Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Raxone in LHON Patients (NCT NCT02774005)
NCT ID: NCT02774005
Last Updated: 2023-04-21
Results Overview
Proportion (number) of eyes with clinically relevant recovery of visual acuity (VA) from Baseline or in which Baseline VA better than 1.0 logMAR was maintained at Month 12 in patients treated with Raxone® ≤1 year after the onset of symptoms, compared to matching external natural history control group
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
199 participants
Primary outcome timeframe
12 months
Results posted on
2023-04-21
Participant Flow
Participant milestones
| Measure |
Raxone
Raxone® (idebenone) 150 mg film-coated tablets. 900 mg/day (2 x 150 mg taken orally 3 times daily with meals)
|
|---|---|
|
Overall Study
STARTED
|
199
|
|
Overall Study
Safety Population
|
198
|
|
Overall Study
Intent-to-Treat (ITT) Population
|
196
|
|
Overall Study
Modified Intent-to-Treat (mITT) Population
|
181
|
|
Overall Study
COMPLETED
|
138
|
|
Overall Study
NOT COMPLETED
|
61
|
Reasons for withdrawal
| Measure |
Raxone
Raxone® (idebenone) 150 mg film-coated tablets. 900 mg/day (2 x 150 mg taken orally 3 times daily with meals)
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Withdrawal by Subject
|
23
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Genetic diagnosis reveals that a patient does not harbour a LHON-specific mtDNA mutation
|
12
|
|
Overall Study
Due to Covid-19 lockdown V9 was not completed
|
1
|
|
Overall Study
Pt not willing to perform onsite V9,did not withdraw consent,not triggered by Covid19 situation
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Patient unable to return for visits. Sent medication back to site
|
1
|
|
Overall Study
Lack of compliance with study medication
|
4
|
|
Overall Study
subject is enrolling in a different LHON study that excludes use of idebenone
|
1
|
|
Overall Study
another study
|
1
|
|
Overall Study
cardiologist imposed travel restriction
|
1
|
Baseline Characteristics
Study to Assess the Efficacy and Safety of Raxone in LHON Patients
Baseline characteristics by cohort
| Measure |
Raxone
n=199 Participants
Raxone® (idebenone) 150 mg film-coated tablets. 900 mg/day (2 x 150 mg taken orally 3 times daily with meals)
|
|---|---|
|
Age, Categorical
<=18 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
164 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
131 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
15 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
12 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
29 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: In the Month 12 dataset with eyes ≤ 1 year after the onset of symptoms at Baseline, used in the evaluation of the primary endpoint, there were 80 patients in the LEROS mITT who contributed 142 eyes for the evaluation.
Proportion (number) of eyes with clinically relevant recovery of visual acuity (VA) from Baseline or in which Baseline VA better than 1.0 logMAR was maintained at Month 12 in patients treated with Raxone® ≤1 year after the onset of symptoms, compared to matching external natural history control group
Outcome measures
| Measure |
Raxone
n=142 eyes
Raxone® (idebenone) 150 mg film-coated tablets. 900 mg/day (2 x 150 mg taken orally 3 times daily with meals)
|
|---|---|
|
Proportion (Number) of Eyes With Clinically Relevant Recovery of Visual Acuity From Baseline
|
60 eyes
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: In the Month 12 dataset with eyes ≤ 1 year after the onset of symptoms at Baseline, used in the evaluation of the primary endpoint, there were 80 patients in the LEROS mITT who contributed 142 eyes for the evaluation.
CRR is defined as: * Improvement from "off-chart" (the equivalent of Counting fingers, Hand motion, Light perception or No light perception) Visual Acuity to at least 1.6 logMAR value, OR * Improvement of at least 0.2 logMAR value within "on-chart" Visual Acuity A patient had a CRR if at least one eye had CRR. logMAR = Logarithm of the minimum angle of resolution
Outcome measures
| Measure |
Raxone
n=142 eyes
Raxone® (idebenone) 150 mg film-coated tablets. 900 mg/day (2 x 150 mg taken orally 3 times daily with meals)
|
|---|---|
|
Components of the Primary Endpoint: Proportion of Eyes With Clinically Relevant Recovery (CRR) of VA From Baseline at Month 12 Compared to Matching External National History (NH) Control Group
|
47 eyes
|
SECONDARY outcome
Timeframe: 12 monthsFor proportion of eyes in which baseline VA better than 1.0 logMAR was maintained at Month 12 (CRS) compared to matching external NH control group only patients having VA \< 1.0 at baseline are taking into account. Clinically relevant stabilization (CRS) was defined as maintenance of VA \<1.0 logMAR in eyes with VA \<1.0 logMAR at Baseline. A patient had a CRS if at least one eye had CRS. logMAR = Logarithm of the minimum angle of resolution
Outcome measures
| Measure |
Raxone
n=31 eyes
Raxone® (idebenone) 150 mg film-coated tablets. 900 mg/day (2 x 150 mg taken orally 3 times daily with meals)
|
|---|---|
|
Components of the Primary Endpoint: Proportion of Eyes in Which Baseline Visual Acuity (VA) Better Than 1.0 logMAR Was Maintained at Month 12 (Clinically Relevant Stabilization) Compared to Matching External NH Control Group
|
20 eyes
|
Adverse Events
Raxone
Serious events: 27 serious events
Other events: 148 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Raxone
n=198 participants at risk
Raxone® (idebenone) 150 mg film-coated tablets. 900 mg/day (2 x 150 mg taken orally 3 times daily with meals)
|
|---|---|
|
Cardiac disorders
Cardiac Arrest
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Cardiac disorders
Total
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Total
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
General disorders
Total
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
General disorders
Disease Reoccurance
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Immune system disorders
Total
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Total
|
4.0%
8/198 • Number of events 8 • through study completion, an average of 24 months
|
|
Infections and infestations
Appendicitis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Diverticulitis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Pyelonephritis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Trichomoniasis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Urinary tract infection
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Viral infection
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Vulvovaginitis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Total
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
Total
|
1.5%
3/198 • Number of events 7 • through study completion, an average of 24 months
|
|
Investigations
Alanine aminotransferase increased
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
Blood creatine phosphokinase increased
|
0.51%
1/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
Urobilinogen urine increased
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Metabolism and nutrition disorders
Total
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Nervous system disorders
Total
|
2.5%
5/198 • Number of events 5 • through study completion, an average of 24 months
|
|
Nervous system disorders
Dizziness
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Nervous system disorders
Epilepsy
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Nervous system disorders
Migraine
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Nervous system disorders
Multiple sclerosis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Nervous system disorders
Syncope
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Total
|
2.5%
5/198 • Number of events 10 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Suicide attempt
|
1.5%
3/198 • Number of events 3 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Alcohol abuse
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Anxiety disorder
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Delirium
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Depression
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Major depression
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Psychotic behaviour
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Renal and urinary disorders
Total
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Skin and subcutaneous tissue disorders
Total
|
0.51%
1/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Social circumstances
Total
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Social circumstances
Miscarriage of partner
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Hepatobiliary disorders
Hepatic failure
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
Other adverse events
| Measure |
Raxone
n=198 participants at risk
Raxone® (idebenone) 150 mg film-coated tablets. 900 mg/day (2 x 150 mg taken orally 3 times daily with meals)
|
|---|---|
|
Blood and lymphatic system disorders
Total
|
1.5%
3/198 • Number of events 3 • through study completion, an average of 24 months
|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Cardiac disorders
Total
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Cardiac disorders
Coronary artery disease
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Cardiac disorders
Tachycardia
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Congenital, familial and genetic disorders
Total
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Congenital, familial and genetic disorders
Hereditary optic atrophy
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Ear and labyrinth disorders
Total
|
3.0%
6/198 • Number of events 6 • through study completion, an average of 24 months
|
|
Ear and labyrinth disorders
Ear pain
|
1.5%
3/198 • Number of events 3 • through study completion, an average of 24 months
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Ear and labyrinth disorders
Motion sickness
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Endocrine disorders
Total
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Endocrine disorders
Thyroiditis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Eye disorders
Total
|
7.6%
15/198 • Number of events 22 • through study completion, an average of 24 months
|
|
Eye disorders
Blepharitis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Eye disorders
Eye haemorrhage
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Eye disorders
Eye pain
|
2.5%
5/198 • Number of events 5 • through study completion, an average of 24 months
|
|
Eye disorders
Eyelid pain
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Eye disorders
Lacrimation increased
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Eye disorders
Ocular hyperaemia
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Eye disorders
Photophobia
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Eye disorders
Photopsia
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Eye disorders
Pupils unequal
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Eye disorders
Vision blurred
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Eye disorders
Visual acuity reduced
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Eye disorders
Visual impairment
|
2.5%
5/198 • Number of events 5 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Total
|
32.3%
64/198 • Number of events 133 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.5%
3/198 • Number of events 4 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Abdominal migraine
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
8/198 • Number of events 10 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.6%
13/198 • Number of events 14 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Constipation
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Dental caries
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Dental necrosis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
9.6%
19/198 • Number of events 28 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
5/198 • Number of events 9 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Eosinophilic oesophagitis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Food poisoning
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
2/198 • Number of events 10 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Malpositioned teeth
|
0.51%
1/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Nausea
|
7.6%
15/198 • Number of events 20 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Tooth disorder
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Tooth impacted
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Toothache
|
3.5%
7/198 • Number of events 14 • through study completion, an average of 24 months
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
6/198 • Number of events 7 • through study completion, an average of 24 months
|
|
General disorders
Total
|
13.6%
27/198 • Number of events 37 • through study completion, an average of 24 months
|
|
General disorders
Chest pain
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
General disorders
Chills
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
General disorders
Cyst
|
1.0%
2/198 • Number of events 3 • through study completion, an average of 24 months
|
|
General disorders
Fatigue
|
4.0%
8/198 • Number of events 8 • through study completion, an average of 24 months
|
|
General disorders
Influenza like illness
|
2.0%
4/198 • Number of events 5 • through study completion, an average of 24 months
|
|
General disorders
Malaise
|
2.5%
5/198 • Number of events 5 • through study completion, an average of 24 months
|
|
General disorders
Medical device pain
|
0.51%
1/198 • Number of events 2 • through study completion, an average of 24 months
|
|
General disorders
Pain
|
2.0%
4/198 • Number of events 4 • through study completion, an average of 24 months
|
|
General disorders
Polyp
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
General disorders
Pyrexia
|
2.5%
5/198 • Number of events 6 • through study completion, an average of 24 months
|
|
Hepatobiliary disorders
Total
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Immune system disorders
Total
|
2.0%
4/198 • Number of events 7 • through study completion, an average of 24 months
|
|
Immune system disorders
Hypersensitivity
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Immune system disorders
Seasonal allergy
|
1.5%
3/198 • Number of events 6 • through study completion, an average of 24 months
|
|
Infections and infestations
Total
|
34.3%
68/198 • Number of events 127 • through study completion, an average of 24 months
|
|
Infections and infestations
Bacterial abdominal infection
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Bacteriuria
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Bronchitis
|
2.0%
4/198 • Number of events 6 • through study completion, an average of 24 months
|
|
Infections and infestations
Bronchitis viral
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Candida infection
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Cellulitis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Conjunctivitis
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Infections and infestations
Ear infection
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Infections and infestations
Enterobiasis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Eye infection
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Fungal skin infection
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Infections and infestations
Gastroenteritis
|
2.0%
4/198 • Number of events 5 • through study completion, an average of 24 months
|
|
Infections and infestations
Gastroenteritis viral
|
1.5%
3/198 • Number of events 3 • through study completion, an average of 24 months
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Immune system disorders
Hepatitis C
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Herpes zoster
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Hordeolum
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Infection
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Influenza
|
4.0%
8/198 • Number of events 9 • through study completion, an average of 24 months
|
|
Infections and infestations
Lower respiratory tract infection
|
1.5%
3/198 • Number of events 5 • through study completion, an average of 24 months
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
33/198 • Number of events 51 • through study completion, an average of 24 months
|
|
Infections and infestations
Oral herpes
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Pharyngitis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Pulpitis dental
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Rhinitis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Sinusitis
|
3.5%
7/198 • Number of events 8 • through study completion, an average of 24 months
|
|
Infections and infestations
Skin infection
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Tooth abscess
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Tooth infection
|
0.51%
1/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
5/198 • Number of events 7 • through study completion, an average of 24 months
|
|
Infections and infestations
Urinary tract infection
|
2.0%
4/198 • Number of events 5 • through study completion, an average of 24 months
|
|
Infections and infestations
Viral infection
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Total
|
9.1%
18/198 • Number of events 21 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Infections and infestations
Arthropod sting
|
0.51%
1/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.51%
1/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.51%
1/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Product administration error
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Injury, poisoning and procedural complications
Wound
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
Total
|
25.3%
50/198 • Number of events 132 • through study completion, an average of 24 months
|
|
Investigations
Alanine aminotransferase increased
|
7.6%
15/198 • Number of events 16 • through study completion, an average of 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
6.6%
13/198 • Number of events 13 • through study completion, an average of 24 months
|
|
Investigations
Bacterial test positive
|
2.0%
4/198 • Number of events 4 • through study completion, an average of 24 months
|
|
Investigations
Blood alkaline phosphatase increased
|
1.5%
3/198 • Number of events 3 • through study completion, an average of 24 months
|
|
Investigations
Blood bicarbonate decreased
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Investigations
Blood bilirubin increased
|
1.5%
3/198 • Number of events 4 • through study completion, an average of 24 months
|
|
Investigations
Blood cholesterol increased
|
2.0%
4/198 • Number of events 4 • through study completion, an average of 24 months
|
|
Investigations
Blood creatine phosphokinase
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
Blood creatine phosphokinase increased
|
7.1%
14/198 • Number of events 15 • through study completion, an average of 24 months
|
|
Investigations
Blood creatinine increased
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
Blood glucose increased
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
Blood phosphorus decreased
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Investigations
Blood triglycerides increased
|
2.5%
5/198 • Number of events 6 • through study completion, an average of 24 months
|
|
Investigations
Blood urea decreased
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
Blood urea increased
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
Blood uric acid increased
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Investigations
Eosinophil count increased
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.5%
9/198 • Number of events 9 • through study completion, an average of 24 months
|
|
Investigations
Gastric pH decreased
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
Haematocrit decreased
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Investigations
Haemoglobin decreased
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Investigations
Liver function test increased
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
Lymphocyte count decreased
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
Lymphocyte count increased
|
1.5%
3/198 • Number of events 3 • through study completion, an average of 24 months
|
|
Investigations
Mean cell volume increased
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Investigations
Monocyte count decreased
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
Monocyte count increased
|
1.0%
2/198 • Number of events 3 • through study completion, an average of 24 months
|
|
Investigations
Neutrophil count decreased
|
2.0%
4/198 • Number of events 4 • through study completion, an average of 24 months
|
|
Investigations
Neutrophil count increased
|
1.5%
3/198 • Number of events 3 • through study completion, an average of 24 months
|
|
Investigations
Protein urine present
|
2.0%
4/198 • Number of events 5 • through study completion, an average of 24 months
|
|
Investigations
Red blood cell count decreased
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Investigations
Transaminases increased
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
Urinary sediment present
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Investigations
Urine ketone body present
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Investigations
Weight increased
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Investigations
White blood cell count decreased
|
1.5%
3/198 • Number of events 3 • through study completion, an average of 24 months
|
|
Investigations
White blood cells urine positive
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Metabolism and nutrition disorders
Total
|
3.0%
6/198 • Number of events 10 • through study completion, an average of 24 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.5%
3/198 • Number of events 4 • through study completion, an average of 24 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Total
|
12.6%
25/198 • Number of events 38 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
3/198 • Number of events 4 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
9/198 • Number of events 13 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.5%
3/198 • Number of events 5 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.5%
3/198 • Number of events 3 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Total
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Nervous system disorders
Total
|
24.7%
49/198 • Number of events 152 • through study completion, an average of 24 months
|
|
Nervous system disorders
Burning sensation
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Nervous system disorders
Dizziness
|
2.0%
4/198 • Number of events 5 • through study completion, an average of 24 months
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Nervous system disorders
Headache
|
18.7%
37/198 • Number of events 131 • through study completion, an average of 24 months
|
|
Nervous system disorders
Hyperaesthesia
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Nervous system disorders
Migraine
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Nervous system disorders
Ophthalmic migraine
|
0.51%
1/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Nervous system disorders
Presyncope
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Nervous system disorders
Seizure
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Nervous system disorders
Sinus headache
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Nervous system disorders
Somnolence
|
2.0%
4/198 • Number of events 4 • through study completion, an average of 24 months
|
|
Nervous system disorders
Syncope
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Nervous system disorders
Tremor
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Total
|
12.6%
25/198 • Number of events 34 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Anger
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Anxiety
|
2.0%
4/198 • Number of events 4 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Confusional state
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Depressed mood
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Depression
|
4.0%
8/198 • Number of events 8 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Depressive symptom
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Hallucination
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Hallucination, visual
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Insomnia
|
2.0%
4/198 • Number of events 4 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Irritability
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Mood altered
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Mood swings
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Panic attack
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Polydipsia psychogenic
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Restlessness
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Sleep disorder
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Suicidal behaviour
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Renal and urinary disorders
Total
|
4.5%
9/198 • Number of events 12 • through study completion, an average of 24 months
|
|
Renal and urinary disorders
Chromaturia
|
1.5%
3/198 • Number of events 6 • through study completion, an average of 24 months
|
|
Renal and urinary disorders
Glycosuria
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Renal and urinary disorders
Haematuria
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Psychiatric disorders
Urine abnormality
|
1.5%
3/198 • Number of events 3 • through study completion, an average of 24 months
|
|
Reproductive system and breast disorders
Total
|
3.0%
6/198 • Number of events 12 • through study completion, an average of 24 months
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.5%
3/198 • Number of events 9 • through study completion, an average of 24 months
|
|
Reproductive system and breast disorders
Prostatitis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Reproductive system and breast disorders
Testicular pain
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Total
|
16.2%
32/198 • Number of events 65 • through study completion, an average of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.51%
1/198 • Number of events 10 • through study completion, an average of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
12/198 • Number of events 14 • through study completion, an average of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
4/198 • Number of events 7 • through study completion, an average of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
14/198 • Number of events 22 • through study completion, an average of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Social circumstances
Total
|
1.5%
3/198 • Number of events 3 • through study completion, an average of 24 months
|
|
Social circumstances
Orthosis user
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Skin and subcutaneous tissue disorders
Pregnancy of partner
|
1.0%
2/198 • Number of events 2 • through study completion, an average of 24 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.0%
2/198 • Number of events 3 • through study completion, an average of 24 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
6/198 • Number of events 7 • through study completion, an average of 24 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Vascular disorders
Total
|
3.0%
6/198 • Number of events 6 • through study completion, an average of 24 months
|
|
Vascular disorders
Hot flush
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Vascular disorders
Hypertension
|
1.5%
3/198 • Number of events 3 • through study completion, an average of 24 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
|
Vascular disorders
Raynaud's phenomenon
|
0.51%
1/198 • Number of events 1 • through study completion, an average of 24 months
|
Additional Information
Head of Regulatory Affairs EU
Santhera Pharmaceuticals (Switzerland) Ltd
Phone: +41 6190689
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The below agreement was included in the Clinical Trial Agreement : Study Team Member agrees not to publish or refer to the study, in whole or in part, without the prior expressed written consent of the sponsor. Study team member will not use the name of the sponsor or \[name of the study co-ordinating Contract Research Organization (CRO)\] in connection with any publication or promotion without sponsor's or \[name co-ordinating CRO\]'s prior, written consent.
- Publication restrictions are in place
Restriction type: OTHER