Trial Outcomes & Findings for Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease (NCT NCT01306929)
NCT ID: NCT01306929
Last Updated: 2022-02-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
134 participants
Primary outcome timeframe
From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
Results posted on
2022-02-09
Participant Flow
The study recruited adult patients with Huntington's Disease (HD) who had completed studies ACR16C009 (NCT00724048) or TV7820-CNS-20002 (NCT02006472). The first patient was recruited on 24 Mar 2011, and the last patient completed the trial on 5 Jan 2018.
Participant milestones
| Measure |
Pridopidine
Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon.
|
|---|---|
|
Overall Study
STARTED
|
134
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
94
|
Reasons for withdrawal
| Measure |
Pridopidine
Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
23
|
|
Overall Study
Adverse Event
|
21
|
|
Overall Study
Physician Decision
|
13
|
|
Overall Study
Death
|
8
|
|
Overall Study
Withdrawal by parent/guardian
|
5
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Non-compliance with study drug
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Various
|
17
|
Baseline Characteristics
Data available for 132 of 134 patients.
Baseline characteristics by cohort
| Measure |
Pridopidine
n=134 Participants
Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon.
|
|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 9.98 • n=134 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=134 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=134 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=134 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=134 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=134 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=134 Participants
|
|
Race (NIH/OMB)
White
|
129 Participants
n=134 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=134 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=134 Participants
|
|
Region of Enrollment
Canada
|
50 participants
n=134 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=134 Participants
|
|
Weight
|
74.7 kg
STANDARD_DEVIATION 18.6 • n=132 Participants • Data available for 132 of 134 patients.
|
PRIMARY outcome
Timeframe: From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 yearsPopulation: Safety analysis set, including all enrolled patients who received at least 1 dose of study drug.
Outcome measures
| Measure |
Pridopidine
n=134 Participants
Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon.
|
|---|---|
|
Number of Patients With at Least One Adverse Event
|
119 Participants
|
SECONDARY outcome
Timeframe: Baseline and at Month 12, 24, 36, 48, 60, and 72Population: Full analysis set, comprising all enrolled patients who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline UHDRS-TMS assessment.
TMS was defined as the sum of all UHDRS motor domains ratings. The motor section of the UHDRS assesses motor features of Huntington's Disease (HD) with standardized ratings of oculo-motor function, dysarthria, chorea, dystonia, gait, and postural stability. Each of 31 assessments is rated on a scale of 0 (normal) to 4 (marked impairment) for a TMS range of 0-124.
Outcome measures
| Measure |
Pridopidine
n=123 Participants
Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon.
|
|---|---|
|
Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS)
Baseline
|
38.3 score on a scale
Standard Deviation 15.2
|
|
Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS)
Month 12
|
41.5 score on a scale
Standard Deviation 18.7
|
|
Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS)
Month 24
|
41.7 score on a scale
Standard Deviation 20.7
|
|
Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS)
Month 36
|
44.7 score on a scale
Standard Deviation 19.8
|
|
Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS)
Month 48
|
45.3 score on a scale
Standard Deviation 19.7
|
|
Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS)
Month 60
|
45.7 score on a scale
Standard Deviation 20.6
|
|
Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS)
Month 72
|
50.0 score on a scale
Standard Deviation 23.2
|
Adverse Events
Pridopidine
Serious events: 31 serious events
Other events: 119 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Pridopidine
n=134 participants at risk
Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon.
|
|---|---|
|
Cardiac disorders
Arteriosclerosis cornonary artery
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Cardiac disorders
Bungle branch block right
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Cardiac disorders
Cardiac failure congestive
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Cardiac disorders
Myocardial infarction
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Eye disorders
Retinal detachment
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Cellulitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Clostridium difficile colitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Device related infection
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Endocarditis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Gastroenteritis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Periorbital cellulitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Pneumonia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Urinary tract infection
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Fall
|
3.0%
4/134 • Number of events 5 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
3.0%
4/134 • Number of events 5 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Skull fracture
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Laceration
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Starvation
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.75%
1/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Convulsion
|
1.5%
2/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Loss of consciousness
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Balance disorder
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Cognitive disorder
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Encephalitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Status migrainosus
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Syncope
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Agitation
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Depression
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Intentional self-injury
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Abnormal behaviour
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Aggression
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Anxiety
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Completed suicide
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Delirium
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Psychotic disorder
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Suicide attempt
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Vascular disorders
Haematoma
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
Other adverse events
| Measure |
Pridopidine
n=134 participants at risk
Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
6/134 • Number of events 6 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Cardiac disorders
Palpitations
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Cardiac disorders
Tachycardia
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Cardiac disorders
Aortic valve incompetence
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.75%
1/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Cardiac disorders
Bradycardia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Cardiac disorders
Bundle branch block right
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Cardiac disorders
Cardiac failure congestive
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Cardiac disorders
Mitral valve incompetence
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Cardiac disorders
Myocardial infarction
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Ear and labyrinth disorders
Ear pain
|
1.5%
2/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Eye disorders
Asthenopia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Eye disorders
Cataract
|
0.75%
1/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Eye disorders
Conjunctival haemorrhage
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Eye disorders
Conjunctivitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Eye disorders
Dry eye
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Eye disorders
Macular degeneration
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Eye disorders
Photopsia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Eye disorders
Retinal tear
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Eye disorders
Vision blurred
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Eye disorders
Vitreous floaters
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Diarrhoea
|
11.9%
16/134 • Number of events 19 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Nausea
|
8.2%
11/134 • Number of events 15 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
10/134 • Number of events 17 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Constipation
|
5.2%
7/134 • Number of events 7 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Dysphagia
|
5.2%
7/134 • Number of events 8 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
5/134 • Number of events 5 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Dental caries
|
3.0%
4/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Dyspepsia
|
3.0%
4/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Faecal incontinence
|
3.0%
4/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.5%
2/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.5%
2/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Diverticulum
|
0.75%
1/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Gastritis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Gingival disorder
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Oesophagitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Periodontitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Tongue disorder
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Tooth impacted
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
General disorders
Irritability
|
9.7%
13/134 • Number of events 17 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
General disorders
Gait disturbance
|
6.0%
8/134 • Number of events 9 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
General disorders
Fatigue
|
3.0%
4/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
General disorders
Pyrexia
|
3.0%
4/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
General disorders
Asthenia
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
General disorders
Cyst
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
General disorders
Oedema peripheral
|
1.5%
2/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
General disorders
Chest pain
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
General disorders
Facial pain
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
General disorders
Influenza like illness
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
General disorders
Non-cardiac chest pain
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
General disorders
Pain
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Hepatobiliary disorders
Hepatitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Immune system disorders
Seasonal allergy
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Nasopharyngitis
|
11.9%
16/134 • Number of events 22 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
9/134 • Number of events 17 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Sinusitis
|
6.0%
8/134 • Number of events 11 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Urinary tract infection
|
6.0%
8/134 • Number of events 19 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Bronchitis
|
5.2%
7/134 • Number of events 7 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Influenza
|
4.5%
6/134 • Number of events 9 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Gastroenteritis
|
3.0%
4/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Ear infection
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Tooth abscess
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Clostridium difficile colitis
|
1.5%
2/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Fungal skin infection
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Furuncle
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Herpes zoster
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Hordeolum
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Onychomycosis
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Skin infection
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Cellulitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Cystitis
|
0.75%
1/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Diverticulitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Enterococcal infection
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Eye infection
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Gingival infection
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Infected dermal cyst
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Laryngitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Localised infection
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Lower respiratory tract infection
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Oral fungal infection
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Otitis media
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Pneumonia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Pneumonia bacterial
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Rhinitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Tinea pedis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Viral infection
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Wound infection
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Fall
|
34.3%
46/134 • Number of events 148 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Contusion
|
13.4%
18/134 • Number of events 28 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Laceration
|
13.4%
18/134 • Number of events 32 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Excoriation
|
8.2%
11/134 • Number of events 15 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Head injury
|
2.2%
3/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
1.5%
2/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Lip injury
|
1.5%
2/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Overdose
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.5%
2/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Face injury
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.75%
1/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Scratch
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.75%
1/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Injury, poisoning and procedural complications
Wound
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Weight decreased
|
22.4%
30/134 • Number of events 32 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Electrocardiogram abnormal
|
4.5%
6/134 • Number of events 6 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Blood cholesterol increased
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Weight increased
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Blood potassium increased
|
1.5%
2/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Creatinine renal clearance decreased
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Prostatic specific antigen increased
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Albumin globulin ratio increased
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Antibiotic resistant Staphylococcus test positive
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Blood calcium decreased
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Blood creatinine decreased
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Blood creatinine increased
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Blood potassium decreased
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Blood pressure increased
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Body temperature increased
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Creatinine renal clearance abnormal
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Electrocardiogram ST-T change
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Globulins increased
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Glycosylated haemoglobin increased
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Heart rate abnormal
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Occult blood positive
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Protein total increased
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
Smear cervix abnormal
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Investigations
White blood cell count increased
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.7%
5/134 • Number of events 12 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
3/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Iron deficiency
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Magnesium deficiency
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Metabolism and nutrition disorders
Water intoxication
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.2%
7/134 • Number of events 10 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.0%
4/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Arthraglia
|
2.2%
3/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.75%
1/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Ostenopenia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
2.2%
3/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Chorea
|
13.4%
18/134 • Number of events 18 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Headache
|
9.0%
12/134 • Number of events 20 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Dizziness
|
5.2%
7/134 • Number of events 8 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Amnesia
|
3.0%
4/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Somnolence
|
3.0%
4/134 • Number of events 6 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Balance disorder
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Dysarthria
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Syncope
|
2.2%
3/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Speech disorder
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Tongue biting
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Bradykinesia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Cognitive disorder
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Convulsion
|
0.75%
1/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Dizziness postural
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Dystonia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Hemiparesis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Loss of consciousness
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Migraine
|
0.75%
1/134 • Number of events 8 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Paraesthesia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Presyncope
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Restless legs syndrome
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Sciatica
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Nervous system disorders
Sensory loss
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Anxiety
|
20.1%
27/134 • Number of events 29 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Insomnia
|
17.9%
24/134 • Number of events 28 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Depression
|
14.9%
20/134 • Number of events 27 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Suicidal ideation
|
4.5%
6/134 • Number of events 6 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Apathy
|
3.7%
5/134 • Number of events 5 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Agitation
|
3.0%
4/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Anger
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Panic attack
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Adjustment disorder
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Bruxism
|
1.5%
2/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Delusion
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Depressed mood
|
1.5%
2/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Paranoia
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Alcohol abuse
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Anhedonia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Bradyphrenia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Confusional state
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Depressive symptom
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Hallucination
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Hypomania
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Inappropriate affect
|
0.75%
1/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Initial insomnia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Nightmare
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Obsessive thoughts
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Perseveration
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Pressure of speech
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Rapid eye movements sleep abnormal
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Sleep disorder
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Psychiatric disorders
Tachyphrenia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
9/134 • Number of events 10 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Renal and urinary disorders
Hypertonic bladder
|
5.2%
7/134 • Number of events 7 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Renal and urinary disorders
Pollakiuria
|
3.0%
4/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Renal and urinary disorders
Dysuria
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Renal and urinary disorders
Michurition urgency
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Renal and urinary disorders
Incontinence
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Renal and urinary disorders
Renal cyst
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Renal and urinary disorders
Renal failure acute
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Reproductive system and breast disorders
Genital rash
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
3.7%
5/134 • Number of events 5 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
5/134 • Number of events 6 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.2%
3/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Grunting
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiroatry tract congestion
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.5%
10/134 • Number of events 13 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
3.0%
4/134 • Number of events 5 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Social circumstances
Immobilisation prolonged
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Vascular disorders
Hypertension
|
3.0%
4/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Vascular disorders
Hot flush
|
2.2%
3/134 • Number of events 3 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Vascular disorders
Hypotension
|
1.5%
2/134 • Number of events 2 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Vascular disorders
Haematoma
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Vascular disorders
Lymphoedema
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Vascular disorders
Orthostatic hypotension
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Vascular disorders
Peripheral coldness
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Gastrointestinal disorders
Gingivitis
|
0.75%
1/134 • Number of events 1 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
|
Infections and infestations
Tooth infection
|
3.0%
4/134 • Number of events 4 • From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Data and results owned by Sponsor. Results can be used by institution for (a) internal non-commercial research, education and patient care, and (b) as required under applicable laws and regulations. Other uses require prior written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER