Time Frame |
All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 264) regardless of seriousness or relationship to investigational product.
|
Adverse Event Reporting Description |
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (the time from the first infusion of the study drug up to 28 days after the last infusion of study drug). Safety population included all randomized participants who received at least one infusion of Fabrazyme.
|
|
Arm/Group Title
|
Fabrazyme 0.5 mg/kg
|
Fabrazyme 1.0 mg/kg
|
Arm/Group Description |
Fabrazyme 0.5 mg/kg was administere...
|
Fabrazyme 1.0 mg/kg was administere...
|
Arm/Group Description |
Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusion) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
|
Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusion) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
|
|
|
Fabrazyme 0.5 mg/kg
|
Fabrazyme 1.0 mg/kg
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
|
|
Fabrazyme 0.5 mg/kg
|
Fabrazyme 1.0 mg/kg
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
6/16 (37.50%) |
5/15 (33.33%) |
Gastrointestinal disorders |
|
|
GASTROINTESTINAL HAEMORRHAGE |
0/16 (0.00%) |
1/15 (6.67%) |
General disorders |
|
|
MEDICAL DEVICE COMPLICATION |
0/16 (0.00%) |
1/15 (6.67%) |
PYREXIA |
1/16 (6.25%) |
1/15 (6.67%) |
CHILLS |
1/16 (6.25%) |
0/15 (0.00%) |
Infections and infestations |
|
|
CELLULITIS |
1/16 (6.25%) |
0/15 (0.00%) |
ERYSIPELAS |
0/16 (0.00%) |
1/15 (6.67%) |
OTITIS MEDIA |
0/16 (0.00%) |
1/15 (6.67%) |
PNEUMONIA |
0/16 (0.00%) |
1/15 (6.67%) |
SEPSIS |
0/16 (0.00%) |
1/15 (6.67%) |
TINEA PEDIS |
0/16 (0.00%) |
1/15 (6.67%) |
Injury, poisoning and procedural complications |
|
|
MULTIPLE INJURIES |
1/16 (6.25%) |
0/15 (0.00%) |
OVERDOSE |
1/16 (6.25%) |
0/15 (0.00%) |
Investigations |
|
|
BODY MASS INDEX DECREASED |
1/16 (6.25%) |
0/15 (0.00%) |
Nervous system disorders |
|
|
PARAESTHESIA |
1/16 (6.25%) |
1/15 (6.67%) |
TREMOR |
0/16 (0.00%) |
1/15 (6.67%) |
Psychiatric disorders |
|
|
SUICIDAL IDEATION |
1/16 (6.25%) |
0/15 (0.00%) |
Renal and urinary disorders |
|
|
MICROALBUMINURIA |
1/16 (6.25%) |
1/15 (6.67%) |
Respiratory, thoracic and mediastinal disorders |
|
|
COUGH |
0/16 (0.00%) |
1/15 (6.67%) |
Skin and subcutaneous tissue disorders |
|
|
DERMATITIS |
0/16 (0.00%) |
1/15 (6.67%) |
Surgical and medical procedures |
|
|
CENTRAL VENOUS CATHETERISATION |
1/16 (6.25%) |
0/15 (0.00%) |
ELECTIVE SURGERY |
1/16 (6.25%) |
0/15 (0.00%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 18.0
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Fabrazyme 0.5 mg/kg
|
Fabrazyme 1.0 mg/kg
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
16/16 (100.00%) |
15/15 (100.00%) |
Blood and lymphatic system disorders |
|
|
ANAEMIA |
1/16 (6.25%) |
1/15 (6.67%) |
EOSINOPHILIA |
0/16 (0.00%) |
1/15 (6.67%) |
LEUKOPENIA |
0/16 (0.00%) |
2/15 (13.33%) |
LYMPHADENOPATHY |
2/16 (12.50%) |
0/15 (0.00%) |
MONOCYTOPENIA |
0/16 (0.00%) |
1/15 (6.67%) |
Cardiac disorders |
|
|
ARRHYTHMIA |
0/16 (0.00%) |
1/15 (6.67%) |
TACHYCARDIA |
2/16 (12.50%) |
1/15 (6.67%) |
Ear and labyrinth disorders |
|
|
CONDUCTIVE DEAFNESS |
1/16 (6.25%) |
2/15 (13.33%) |
DEAFNESS |
1/16 (6.25%) |
0/15 (0.00%) |
DEAFNESS BILATERAL |
1/16 (6.25%) |
0/15 (0.00%) |
DEAFNESS NEUROSENSORY |
1/16 (6.25%) |
0/15 (0.00%) |
DEAFNESS UNILATERAL |
1/16 (6.25%) |
2/15 (13.33%) |
MIDDLE EAR EFFUSION |
0/16 (0.00%) |
1/15 (6.67%) |
OTORRHOEA |
0/16 (0.00%) |
1/15 (6.67%) |
TINNITUS |
3/16 (18.75%) |
4/15 (26.67%) |
TYMPANIC MEMBRANE HYPERAEMIA |
1/16 (6.25%) |
0/15 (0.00%) |
Endocrine disorders |
|
|
HYPERPARATHYROIDISM SECONDARY |
1/16 (6.25%) |
1/15 (6.67%) |
Eye disorders |
|
|
CONJUNCTIVAL HYPERAEMIA |
0/16 (0.00%) |
2/15 (13.33%) |
CORNEAL DEPOSITS |
1/16 (6.25%) |
0/15 (0.00%) |
DRY EYE |
1/16 (6.25%) |
0/15 (0.00%) |
LACRIMATION INCREASED |
0/16 (0.00%) |
1/15 (6.67%) |
OCULAR VASCULAR DISORDER |
0/16 (0.00%) |
1/15 (6.67%) |
PHOTOPHOBIA |
1/16 (6.25%) |
0/15 (0.00%) |
VISION BLURRED |
0/16 (0.00%) |
1/15 (6.67%) |
VISUAL ACUITY REDUCED |
1/16 (6.25%) |
0/15 (0.00%) |
PERIORBITAL OEDEMA |
1/16 (6.25%) |
0/15 (0.00%) |
Gastrointestinal disorders |
|
|
ABDOMINAL PAIN |
9/16 (56.25%) |
6/15 (40.00%) |
ABDOMINAL PAIN LOWER |
1/16 (6.25%) |
0/15 (0.00%) |
ABDOMINAL PAIN UPPER |
4/16 (25.00%) |
4/15 (26.67%) |
CONSTIPATION |
2/16 (12.50%) |
0/15 (0.00%) |
DENTAL CARIES |
1/16 (6.25%) |
1/15 (6.67%) |
DIARRHOEA |
10/16 (62.50%) |
8/15 (53.33%) |
EPIGASTRIC DISCOMFORT |
0/16 (0.00%) |
1/15 (6.67%) |
FOOD POISONING |
1/16 (6.25%) |
0/15 (0.00%) |
FREQUENT BOWEL MOVEMENTS |
0/16 (0.00%) |
1/15 (6.67%) |
GASTROINTESTINAL DISORDER |
2/16 (12.50%) |
1/15 (6.67%) |
NAUSEA |
9/16 (56.25%) |
7/15 (46.67%) |
ORAL MUCOSAL ERYTHEMA |
0/16 (0.00%) |
1/15 (6.67%) |
SALIVARY HYPERSECRETION |
0/16 (0.00%) |
1/15 (6.67%) |
STOMATITIS |
1/16 (6.25%) |
0/15 (0.00%) |
TOOTHACHE |
0/16 (0.00%) |
1/15 (6.67%) |
VOMITING |
9/16 (56.25%) |
7/15 (46.67%) |
ABDOMINAL TENDERNESS |
1/16 (6.25%) |
0/15 (0.00%) |
IRRITABLE BOWEL SYNDROME |
1/16 (6.25%) |
0/15 (0.00%) |
General disorders |
|
|
ASTHENIA |
3/16 (18.75%) |
1/15 (6.67%) |
CATHETER SITE PAIN |
0/16 (0.00%) |
1/15 (6.67%) |
CHEST DISCOMFORT |
0/16 (0.00%) |
2/15 (13.33%) |
CHILLS |
6/16 (37.50%) |
2/15 (13.33%) |
FACE OEDEMA |
2/16 (12.50%) |
0/15 (0.00%) |
FATIGUE |
5/16 (31.25%) |
2/15 (13.33%) |
FEELING COLD |
3/16 (18.75%) |
1/15 (6.67%) |
FEELING HOT |
0/16 (0.00%) |
3/15 (20.00%) |
FEELING OF BODY TEMPERATURE CHANGE |
0/16 (0.00%) |
1/15 (6.67%) |
INFLUENZA LIKE ILLNESS |
2/16 (12.50%) |
0/15 (0.00%) |
INFUSION SITE PAIN |
1/16 (6.25%) |
0/15 (0.00%) |
INJECTION SITE HAEMORRHAGE |
1/16 (6.25%) |
0/15 (0.00%) |
MALAISE |
2/16 (12.50%) |
1/15 (6.67%) |
MEDICAL DEVICE COMPLICATION |
1/16 (6.25%) |
1/15 (6.67%) |
OEDEMA PERIPHERAL |
3/16 (18.75%) |
2/15 (13.33%) |
PAIN |
4/16 (25.00%) |
3/15 (20.00%) |
PYREXIA |
12/16 (75.00%) |
8/15 (53.33%) |
SOFT TISSUE INFLAMMATION |
0/16 (0.00%) |
1/15 (6.67%) |
GENERAL PHYSICAL HEALTH DETERIORATION |
1/16 (6.25%) |
0/15 (0.00%) |
INFUSION SITE EXTRAVASATION |
1/16 (6.25%) |
0/15 (0.00%) |
Immune system disorders |
|
|
ALLERGY TO ARTHROPOD BITE |
0/16 (0.00%) |
1/15 (6.67%) |
Infections and infestations |
|
|
ACUTE SINUSITIS |
1/16 (6.25%) |
0/15 (0.00%) |
BRONCHITIS |
1/16 (6.25%) |
1/15 (6.67%) |
CATHETER SITE INFECTION |
0/16 (0.00%) |
1/15 (6.67%) |
CHLAMYDIAL INFECTION |
0/16 (0.00%) |
1/15 (6.67%) |
CONJUNCTIVITIS |
0/16 (0.00%) |
1/15 (6.67%) |
COXSACKIE VIRAL INFECTION |
1/16 (6.25%) |
0/15 (0.00%) |
EAR INFECTION |
5/16 (31.25%) |
1/15 (6.67%) |
ENTEROBIASIS |
0/16 (0.00%) |
1/15 (6.67%) |
ERYSIPELAS |
0/16 (0.00%) |
1/15 (6.67%) |
GASTROENTERITIS |
2/16 (12.50%) |
2/15 (13.33%) |
GASTROENTERITIS VIRAL |
3/16 (18.75%) |
1/15 (6.67%) |
HERPES SIMPLEX |
1/16 (6.25%) |
1/15 (6.67%) |
HERPES VIRUS INFECTION |
0/16 (0.00%) |
1/15 (6.67%) |
IMPETIGO |
2/16 (12.50%) |
1/15 (6.67%) |
INFLUENZA |
3/16 (18.75%) |
3/15 (20.00%) |
LOWER RESPIRATORY TRACT INFECTION |
0/16 (0.00%) |
1/15 (6.67%) |
MOLLUSCUM CONTAGIOSUM |
0/16 (0.00%) |
1/15 (6.67%) |
NASOPHARYNGITIS |
7/16 (43.75%) |
5/15 (33.33%) |
ORAL HERPES |
2/16 (12.50%) |
0/15 (0.00%) |
OTITIS MEDIA CHRONIC |
0/16 (0.00%) |
1/15 (6.67%) |
PARASITIC GASTROENTERITIS |
0/16 (0.00%) |
1/15 (6.67%) |
PHARYNGITIS |
2/16 (12.50%) |
0/15 (0.00%) |
PHARYNGITIS STREPTOCOCCAL |
2/16 (12.50%) |
0/15 (0.00%) |
PNEUMONIA |
0/16 (0.00%) |
1/15 (6.67%) |
RESPIRATORY TRACT INFECTION |
0/16 (0.00%) |
2/15 (13.33%) |
RESPIRATORY TRACT INFECTION VIRAL |
1/16 (6.25%) |
0/15 (0.00%) |
RHINITIS |
5/16 (31.25%) |
3/15 (20.00%) |
SINUSITIS |
3/16 (18.75%) |
1/15 (6.67%) |
STAPHYLOCOCCAL INFECTION |
1/16 (6.25%) |
0/15 (0.00%) |
TINEA INFECTION |
0/16 (0.00%) |
1/15 (6.67%) |
TINEA VERSICOLOUR |
1/16 (6.25%) |
0/15 (0.00%) |
TONSILLITIS |
1/16 (6.25%) |
0/15 (0.00%) |
TOOTH INFECTION |
0/16 (0.00%) |
1/15 (6.67%) |
UPPER RESPIRATORY TRACT INFECTION |
6/16 (37.50%) |
5/15 (33.33%) |
VIRAL INFECTION |
2/16 (12.50%) |
1/15 (6.67%) |
VIRAL PHARYNGITIS |
0/16 (0.00%) |
1/15 (6.67%) |
VIRAL RHINITIS |
1/16 (6.25%) |
0/15 (0.00%) |
VIRAL UPPER RESPIRATORY TRACT INFECTION |
1/16 (6.25%) |
1/15 (6.67%) |
HORDEOLUM |
1/16 (6.25%) |
0/15 (0.00%) |
Injury, poisoning and procedural complications |
|
|
ANIMAL BITE |
1/16 (6.25%) |
1/15 (6.67%) |
ARTHROPOD BITE |
0/16 (0.00%) |
1/15 (6.67%) |
ARTHROPOD STING |
0/16 (0.00%) |
2/15 (13.33%) |
CONCUSSION |
1/16 (6.25%) |
0/15 (0.00%) |
CONTUSION |
2/16 (12.50%) |
1/15 (6.67%) |
EAR INJURY |
0/16 (0.00%) |
1/15 (6.67%) |
EXCORIATION |
0/16 (0.00%) |
1/15 (6.67%) |
FALL |
1/16 (6.25%) |
0/15 (0.00%) |
FROSTBITE |
1/16 (6.25%) |
0/15 (0.00%) |
GENITAL INJURY |
1/16 (6.25%) |
0/15 (0.00%) |
HAND FRACTURE |
1/16 (6.25%) |
0/15 (0.00%) |
HEAD INJURY |
0/16 (0.00%) |
1/15 (6.67%) |
HUMERUS FRACTURE |
1/16 (6.25%) |
0/15 (0.00%) |
JOINT INJURY |
0/16 (0.00%) |
1/15 (6.67%) |
LACERATION |
0/16 (0.00%) |
1/15 (6.67%) |
LIGAMENT RUPTURE |
1/16 (6.25%) |
0/15 (0.00%) |
LIGAMENT SPRAIN |
1/16 (6.25%) |
1/15 (6.67%) |
LIMB INJURY |
1/16 (6.25%) |
1/15 (6.67%) |
MUSCLE RUPTURE |
1/16 (6.25%) |
0/15 (0.00%) |
MUSCLE STRAIN |
0/16 (0.00%) |
1/15 (6.67%) |
OVERDOSE |
1/16 (6.25%) |
0/15 (0.00%) |
POST-TRAUMATIC PAIN |
0/16 (0.00%) |
1/15 (6.67%) |
PROCEDURAL PAIN |
0/16 (0.00%) |
2/15 (13.33%) |
ROAD TRAFFIC ACCIDENT |
1/16 (6.25%) |
1/15 (6.67%) |
SKIN ABRASION |
1/16 (6.25%) |
1/15 (6.67%) |
SOFT TISSUE INJURY |
0/16 (0.00%) |
1/15 (6.67%) |
TOOTH FRACTURE |
0/16 (0.00%) |
2/15 (13.33%) |
WOUND COMPLICATION |
1/16 (6.25%) |
0/15 (0.00%) |
WOUND DEHISCENCE |
1/16 (6.25%) |
0/15 (0.00%) |
TENDON RUPTURE |
1/16 (6.25%) |
0/15 (0.00%) |
Investigations |
|
|
BETA 2 MICROGLOBULIN INCREASED |
0/16 (0.00%) |
1/15 (6.67%) |
BLOOD PRESSURE INCREASED |
0/16 (0.00%) |
1/15 (6.67%) |
BODY TEMPERATURE INCREASED |
0/16 (0.00%) |
1/15 (6.67%) |
EOSINOPHIL COUNT INCREASED |
1/16 (6.25%) |
0/15 (0.00%) |
HEART RATE INCREASED |
0/16 (0.00%) |
1/15 (6.67%) |
NEUTROPHIL COUNT INCREASED |
1/16 (6.25%) |
1/15 (6.67%) |
URINE ALBUMIN/CREATININE RATIO ABNORMAL |
1/16 (6.25%) |
0/15 (0.00%) |
VITAMIN B12 DECREASED |
0/16 (0.00%) |
2/15 (13.33%) |
VITAMIN D DECREASED |
1/16 (6.25%) |
1/15 (6.67%) |
PROTEIN URINE PRESENT |
1/16 (6.25%) |
0/15 (0.00%) |
Metabolism and nutrition disorders |
|
|
FAILURE TO THRIVE |
0/16 (0.00%) |
1/15 (6.67%) |
HYPOPHOSPHATAEMIA |
0/16 (0.00%) |
1/15 (6.67%) |
IRON DEFICIENCY |
1/16 (6.25%) |
0/15 (0.00%) |
OBESITY |
0/16 (0.00%) |
1/15 (6.67%) |
UNDERWEIGHT |
1/16 (6.25%) |
1/15 (6.67%) |
VITAMIN D DEFICIENCY |
0/16 (0.00%) |
1/15 (6.67%) |
VITAMIN B12 DEFICIENCY |
1/16 (6.25%) |
0/15 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
ARTHRALGIA |
4/16 (25.00%) |
1/15 (6.67%) |
BACK PAIN |
2/16 (12.50%) |
2/15 (13.33%) |
FOOT DEFORMITY |
1/16 (6.25%) |
0/15 (0.00%) |
GROIN PAIN |
1/16 (6.25%) |
0/15 (0.00%) |
HAEMARTHROSIS |
0/16 (0.00%) |
1/15 (6.67%) |
INTERVERTEBRAL DISC PROTRUSION |
1/16 (6.25%) |
0/15 (0.00%) |
JOINT RANGE OF MOTION DECREASED |
0/16 (0.00%) |
1/15 (6.67%) |
MUSCLE SPASMS |
1/16 (6.25%) |
0/15 (0.00%) |
MUSCULOSKELETAL PAIN |
1/16 (6.25%) |
0/15 (0.00%) |
MYALGIA |
2/16 (12.50%) |
0/15 (0.00%) |
NECK PAIN |
3/16 (18.75%) |
0/15 (0.00%) |
PAIN IN EXTREMITY |
8/16 (50.00%) |
5/15 (33.33%) |
TENDONITIS |
0/16 (0.00%) |
1/15 (6.67%) |
JOINT SWELLING |
1/16 (6.25%) |
0/15 (0.00%) |
MUSCULAR WEAKNESS |
1/16 (6.25%) |
0/15 (0.00%) |
MUSCULOSKELETAL CHEST PAIN |
1/16 (6.25%) |
1/15 (6.67%) |
Nervous system disorders |
|
|
BURNING SENSATION |
1/16 (6.25%) |
1/15 (6.67%) |
DISTURBANCE IN ATTENTION |
1/16 (6.25%) |
0/15 (0.00%) |
DIZZINESS |
4/16 (25.00%) |
4/15 (26.67%) |
DYSGEUSIA |
1/16 (6.25%) |
0/15 (0.00%) |
HEADACHE |
8/16 (50.00%) |
4/15 (26.67%) |
MIGRAINE |
1/16 (6.25%) |
1/15 (6.67%) |
PARAESTHESIA |
6/16 (37.50%) |
3/15 (20.00%) |
PRESYNCOPE |
2/16 (12.50%) |
1/15 (6.67%) |
SLOW RESPONSE TO STIMULI |
1/16 (6.25%) |
0/15 (0.00%) |
SPEECH DISORDER |
0/16 (0.00%) |
1/15 (6.67%) |
TREMOR |
1/16 (6.25%) |
0/15 (0.00%) |
HYPOAESTHESIA |
1/16 (6.25%) |
0/15 (0.00%) |
Psychiatric disorders |
|
|
ABNORMAL BEHAVIOUR |
1/16 (6.25%) |
0/15 (0.00%) |
ANXIETY |
1/16 (6.25%) |
1/15 (6.67%) |
CONFUSIONAL STATE |
1/16 (6.25%) |
0/15 (0.00%) |
DEPRESSION |
0/16 (0.00%) |
1/15 (6.67%) |
DEPRESSIVE SYMPTOM |
1/16 (6.25%) |
0/15 (0.00%) |
DISORIENTATION |
1/16 (6.25%) |
0/15 (0.00%) |
DYSPHORIA |
1/16 (6.25%) |
0/15 (0.00%) |
HALLUCINATION |
1/16 (6.25%) |
0/15 (0.00%) |
INSOMNIA |
2/16 (12.50%) |
0/15 (0.00%) |
LISTLESS |
1/16 (6.25%) |
0/15 (0.00%) |
PANIC ATTACK |
0/16 (0.00%) |
1/15 (6.67%) |
SLEEP DISORDER |
2/16 (12.50%) |
0/15 (0.00%) |
Renal and urinary disorders |
|
|
HAEMATURIA |
2/16 (12.50%) |
1/15 (6.67%) |
HYDRONEPHROSIS |
1/16 (6.25%) |
0/15 (0.00%) |
HYDROURETER |
1/16 (6.25%) |
0/15 (0.00%) |
MICROALBUMINURIA |
0/16 (0.00%) |
1/15 (6.67%) |
Reproductive system and breast disorders |
|
|
PENILE DISCHARGE |
0/16 (0.00%) |
1/15 (6.67%) |
PENILE PAIN |
0/16 (0.00%) |
1/15 (6.67%) |
SCROTAL ANGIOKERATOMA |
2/16 (12.50%) |
1/15 (6.67%) |
Respiratory, thoracic and mediastinal disorders |
|
|
ALLERGIC COUGH |
1/16 (6.25%) |
0/15 (0.00%) |
ALLERGIC RESPIRATORY SYMPTOM |
0/16 (0.00%) |
1/15 (6.67%) |
BRONCHIAL OBSTRUCTION |
1/16 (6.25%) |
1/15 (6.67%) |
BRONCHOSPASM |
1/16 (6.25%) |
1/15 (6.67%) |
COUGH |
8/16 (50.00%) |
5/15 (33.33%) |
DRY THROAT |
0/16 (0.00%) |
1/15 (6.67%) |
DYSPNOEA |
3/16 (18.75%) |
2/15 (13.33%) |
EPISTAXIS |
3/16 (18.75%) |
1/15 (6.67%) |
NASAL CONGESTION |
5/16 (31.25%) |
1/15 (6.67%) |
OROPHARYNGEAL PAIN |
3/16 (18.75%) |
6/15 (40.00%) |
PHARYNGEAL ERYTHEMA |
1/16 (6.25%) |
0/15 (0.00%) |
RESPIRATORY FAILURE |
1/16 (6.25%) |
0/15 (0.00%) |
RESPIRATORY TRACT CONGESTION |
0/16 (0.00%) |
1/15 (6.67%) |
RHINITIS ALLERGIC |
1/16 (6.25%) |
0/15 (0.00%) |
RHINORRHOEA |
1/16 (6.25%) |
1/15 (6.67%) |
SINUS CONGESTION |
1/16 (6.25%) |
1/15 (6.67%) |
SNEEZING |
1/16 (6.25%) |
0/15 (0.00%) |
TACHYPNOEA |
0/16 (0.00%) |
1/15 (6.67%) |
THROAT IRRITATION |
0/16 (0.00%) |
1/15 (6.67%) |
TONSILLAR HYPERTROPHY |
1/16 (6.25%) |
0/15 (0.00%) |
UPPER RESPIRATORY TRACT CONGESTION |
0/16 (0.00%) |
1/15 (6.67%) |
WHEEZING |
1/16 (6.25%) |
0/15 (0.00%) |
CATARRH |
1/16 (6.25%) |
0/15 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
ACNE |
1/16 (6.25%) |
0/15 (0.00%) |
ANGIOKERATOMA |
9/16 (56.25%) |
5/15 (33.33%) |
BLISTER |
0/16 (0.00%) |
1/15 (6.67%) |
DERMATITIS |
0/16 (0.00%) |
1/15 (6.67%) |
DERMATITIS CONTACT |
2/16 (12.50%) |
2/15 (13.33%) |
DRY SKIN |
1/16 (6.25%) |
0/15 (0.00%) |
ECZEMA |
1/16 (6.25%) |
1/15 (6.67%) |
ERYTHEMA |
4/16 (25.00%) |
1/15 (6.67%) |
HYPERHIDROSIS |
0/16 (0.00%) |
1/15 (6.67%) |
MILIARIA |
0/16 (0.00%) |
1/15 (6.67%) |
NIGHT SWEATS |
0/16 (0.00%) |
1/15 (6.67%) |
PETECHIAE |
0/16 (0.00%) |
1/15 (6.67%) |
RASH |
4/16 (25.00%) |
1/15 (6.67%) |
RASH ERYTHEMATOUS |
1/16 (6.25%) |
0/15 (0.00%) |
RASH MACULAR |
1/16 (6.25%) |
1/15 (6.67%) |
SWELLING FACE |
2/16 (12.50%) |
1/15 (6.67%) |
TELANGIECTASIA |
0/16 (0.00%) |
1/15 (6.67%) |
UMBILICAL ERYTHEMA |
0/16 (0.00%) |
1/15 (6.67%) |
PRURITUS |
1/16 (6.25%) |
2/15 (13.33%) |
Surgical and medical procedures |
|
|
SINUS OPERATION |
1/16 (6.25%) |
0/15 (0.00%) |
Vascular disorders |
|
|
ANGIOPATHY |
0/16 (0.00%) |
1/15 (6.67%) |
FLUSHING |
1/16 (6.25%) |
0/15 (0.00%) |
HYPOTENSION |
1/16 (6.25%) |
1/15 (6.67%) |
PALLOR |
2/16 (12.50%) |
1/15 (6.67%) |
RAYNAUD'S PHENOMENON |
0/16 (0.00%) |
1/15 (6.67%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 18.0
|