Time Frame |
All Adverse Events (AE) were collected from signature of the informed consent form in the extension study up to the end of extension study visit (up to Year 6) regardless of seriousness or relationship to investigational product.
|
Adverse Event Reporting Description |
Reported AEs are treatment-emergent adverse events (TEAEs), AEs that developed/worsened during or at any time after first alemtuzumab treatment. Alemtuzumab TEAEs were defined as AEs with start dates and start times on or after the date and time of the first alemtuzumab treatment in CAMMS03409 or in prior studies (CAMMS223, CAMMS323, or CAMMS324).
|
|
Arm/Group Title
|
Alemtuzumab
|
Arm/Group Description |
Participants enrolled in any of the...
|
Arm/Group Description |
Participants enrolled in any of the previous studies who had received alemtuzumab. Participants enrolled in any of the previous studies who had received IFNB-1a, who received alemtuzumab 12 mg/day infusion in this study.
|
|
|
Alemtuzumab
|
|
Affected / at Risk (%) |
Total |
--/-- |
|
|
Alemtuzumab
|
|
Affected / at Risk (%) |
Total |
376/1314 (28.61%) |
Blood and lymphatic system disorders |
|
Acquired haemophilia |
1/1314 (0.08%) |
Anaemia |
3/1314 (0.23%) |
Autoimmune haemolytic anaemia |
1/1314 (0.08%) |
Autoimmune pancytopenia |
1/1314 (0.08%) |
Febrile neutropenia |
1/1314 (0.08%) |
Haemolytic anaemia |
2/1314 (0.15%) |
Haemorrhagic anaemia |
1/1314 (0.08%) |
Immune thrombocytopenic purpura |
16/1314 (1.22%) |
Lymphadenopathy |
1/1314 (0.08%) |
Neutropenia |
1/1314 (0.08%) |
Pancytopenia |
1/1314 (0.08%) |
Thrombocytopenia |
1/1314 (0.08%) |
Cardiac disorders |
|
Acute myocardial infarction |
3/1314 (0.23%) |
Angina pectoris |
4/1314 (0.30%) |
Atrial fibrillation |
1/1314 (0.08%) |
Bradycardia |
2/1314 (0.15%) |
Bradycardia foetal |
1/1314 (0.08%) |
Bradycardia neonatal |
1/1314 (0.08%) |
Bundle branch block right |
1/1314 (0.08%) |
Cardiac arrest |
1/1314 (0.08%) |
Cardiac failure congestive |
2/1314 (0.15%) |
Congestive cardiomyopathy |
1/1314 (0.08%) |
Myocardial infarction |
2/1314 (0.15%) |
Pericarditis |
1/1314 (0.08%) |
Sinus bradycardia |
1/1314 (0.08%) |
Tachycardia |
3/1314 (0.23%) |
Congenital, familial and genetic disorders |
|
Foetal cystic hygroma |
1/1314 (0.08%) |
Ear and labyrinth disorders |
|
Vertigo |
1/1314 (0.08%) |
Endocrine disorders |
|
Autoimmune hypothyroidism |
1/1314 (0.08%) |
Autoimmune thyroiditis |
4/1314 (0.30%) |
Basedow's disease |
39/1314 (2.97%) |
Goitre |
3/1314 (0.23%) |
Hyperparathyroidism |
1/1314 (0.08%) |
Hyperthyroidism |
14/1314 (1.07%) |
Hypothyroidism |
4/1314 (0.30%) |
Eye disorders |
|
Cataract |
1/1314 (0.08%) |
Endocrine ophthalmopathy |
4/1314 (0.30%) |
Glaucoma |
1/1314 (0.08%) |
Iridocyclitis |
1/1314 (0.08%) |
Optic atrophy |
1/1314 (0.08%) |
Vision blurred |
1/1314 (0.08%) |
Gastrointestinal disorders |
|
Abdominal distension |
1/1314 (0.08%) |
Abdominal hernia |
1/1314 (0.08%) |
Abdominal pain |
11/1314 (0.84%) |
Abdominal pain upper |
1/1314 (0.08%) |
Ascites |
1/1314 (0.08%) |
Colitis |
3/1314 (0.23%) |
Colitis ischaemic |
1/1314 (0.08%) |
Constipation |
1/1314 (0.08%) |
Diarrhoea |
3/1314 (0.23%) |
Duodenitis |
1/1314 (0.08%) |
Enteritis |
1/1314 (0.08%) |
Faecaloma |
1/1314 (0.08%) |
Gastric ulcer haemorrhage |
1/1314 (0.08%) |
Gastritis |
2/1314 (0.15%) |
Impaired gastric emptying |
1/1314 (0.08%) |
Inguinal hernia |
2/1314 (0.15%) |
Nausea |
7/1314 (0.53%) |
Oesophagitis |
1/1314 (0.08%) |
Pancreatic fistula |
1/1314 (0.08%) |
Pancreatic pseudocyst |
1/1314 (0.08%) |
Pancreatitis |
1/1314 (0.08%) |
Pancreatitis acute |
1/1314 (0.08%) |
Peptic ulcer |
1/1314 (0.08%) |
Small intestinal obstruction |
1/1314 (0.08%) |
Upper gastrointestinal haemorrhage |
1/1314 (0.08%) |
Vomiting |
6/1314 (0.46%) |
General disorders |
|
Catheter site pain |
1/1314 (0.08%) |
Chest pain |
1/1314 (0.08%) |
Chills |
1/1314 (0.08%) |
Death |
1/1314 (0.08%) |
Device dislocation |
1/1314 (0.08%) |
Fatigue |
1/1314 (0.08%) |
Inflammation |
1/1314 (0.08%) |
Non-cardiac chest pain |
2/1314 (0.15%) |
Perforated ulcer |
1/1314 (0.08%) |
Pyrexia |
2/1314 (0.15%) |
Hepatobiliary disorders |
|
Biliary dyskinesia |
1/1314 (0.08%) |
Cholangitis |
1/1314 (0.08%) |
Cholecystitis |
4/1314 (0.30%) |
Cholecystitis acute |
2/1314 (0.15%) |
Cholelithiasis |
4/1314 (0.30%) |
Hepatitis acute |
1/1314 (0.08%) |
Sphincter of Oddi dysfunction |
1/1314 (0.08%) |
Immune system disorders |
|
Anaphylactoid reaction |
1/1314 (0.08%) |
Drug hypersensitivity |
1/1314 (0.08%) |
Hypersensitivity |
3/1314 (0.23%) |
Infections and infestations |
|
Abscess bacterial |
1/1314 (0.08%) |
Abscess limb |
1/1314 (0.08%) |
Appendicitis |
2/1314 (0.15%) |
Appendicitis perforated |
1/1314 (0.08%) |
Bone abscess |
1/1314 (0.08%) |
Breast abscess |
1/1314 (0.08%) |
Bronchitis |
1/1314 (0.08%) |
Cellulitis |
6/1314 (0.46%) |
Chronic hepatitis C |
1/1314 (0.08%) |
Device related infection |
1/1314 (0.08%) |
Diverticulitis |
2/1314 (0.15%) |
Endometritis |
1/1314 (0.08%) |
Escherichia urinary tract infection |
1/1314 (0.08%) |
Furuncle |
1/1314 (0.08%) |
Gastroenteritis |
7/1314 (0.53%) |
Gastroenteritis bacterial |
1/1314 (0.08%) |
Gastroenteritis viral |
2/1314 (0.15%) |
HIV infection |
1/1314 (0.08%) |
Helicobacter infection |
1/1314 (0.08%) |
Herpes zoster |
10/1314 (0.76%) |
Infection |
1/1314 (0.08%) |
Infectious colitis |
1/1314 (0.08%) |
Infective myositis |
1/1314 (0.08%) |
Influenza |
2/1314 (0.15%) |
Lower respiratory tract infection |
2/1314 (0.15%) |
Lung abscess |
1/1314 (0.08%) |
Oral herpes |
1/1314 (0.08%) |
Pancreas infection |
1/1314 (0.08%) |
Pneumonia |
13/1314 (0.99%) |
Pneumonia fungal |
1/1314 (0.08%) |
Pneumonia legionella |
1/1314 (0.08%) |
Post procedural infection |
1/1314 (0.08%) |
Pulmonary tuberculosis |
1/1314 (0.08%) |
Pyelonephritis |
4/1314 (0.30%) |
Pyelonephritis acute |
1/1314 (0.08%) |
Respiratory tract infection viral |
2/1314 (0.15%) |
Scrotal abscess |
1/1314 (0.08%) |
Sepsis |
8/1314 (0.61%) |
Soft tissue infection |
1/1314 (0.08%) |
Staphylococcal abscess |
1/1314 (0.08%) |
Subcutaneous abscess |
1/1314 (0.08%) |
Tracheobronchitis |
1/1314 (0.08%) |
Tubo-ovarian abscess |
1/1314 (0.08%) |
Urinary tract infection |
7/1314 (0.53%) |
Urosepsis |
1/1314 (0.08%) |
Varicella zoster virus infection |
1/1314 (0.08%) |
Viral infection |
1/1314 (0.08%) |
Injury, poisoning and procedural complications |
|
Accidental overdose |
1/1314 (0.08%) |
Ankle fracture |
1/1314 (0.08%) |
Cartilage injury |
1/1314 (0.08%) |
Cervical vertebral fracture |
1/1314 (0.08%) |
Concussion |
3/1314 (0.23%) |
Contusion |
2/1314 (0.15%) |
Femur fracture |
1/1314 (0.08%) |
Fibula fracture |
2/1314 (0.15%) |
Gastrostomy failure |
1/1314 (0.08%) |
Hip fracture |
1/1314 (0.08%) |
Humerus fracture |
1/1314 (0.08%) |
Incision site oedema |
1/1314 (0.08%) |
Intentional overdose |
2/1314 (0.15%) |
Laceration |
2/1314 (0.15%) |
Ligament sprain |
1/1314 (0.08%) |
Lumbar vertebral fracture |
1/1314 (0.08%) |
Meniscus injury |
1/1314 (0.08%) |
Multiple fractures |
1/1314 (0.08%) |
Overdose |
2/1314 (0.15%) |
Pancreatic injury |
1/1314 (0.08%) |
Pelvic fracture |
1/1314 (0.08%) |
Post lumbar puncture syndrome |
1/1314 (0.08%) |
Post procedural fistula |
1/1314 (0.08%) |
Post procedural haematoma |
1/1314 (0.08%) |
Procedural nausea |
1/1314 (0.08%) |
Procedural pain |
1/1314 (0.08%) |
Skull fractured base |
1/1314 (0.08%) |
Spinal column injury |
1/1314 (0.08%) |
Splenic rupture |
1/1314 (0.08%) |
Subdural haematoma |
1/1314 (0.08%) |
Tibia fracture |
2/1314 (0.15%) |
Ulna fracture |
1/1314 (0.08%) |
Wound |
1/1314 (0.08%) |
Wound dehiscence |
1/1314 (0.08%) |
Wrist fracture |
2/1314 (0.15%) |
Investigations |
|
Blood creatinine increased |
1/1314 (0.08%) |
Urine ketone body present |
1/1314 (0.08%) |
Metabolism and nutrition disorders |
|
Dehydration |
6/1314 (0.46%) |
Diabetic ketoacidosis |
1/1314 (0.08%) |
Electrolyte imbalance |
1/1314 (0.08%) |
Hyperglycaemia |
1/1314 (0.08%) |
Hypocalcaemia |
2/1314 (0.15%) |
Hypokalaemia |
2/1314 (0.15%) |
Hypophosphataemia |
1/1314 (0.08%) |
Malnutrition |
1/1314 (0.08%) |
Obesity |
1/1314 (0.08%) |
Type 1 diabetes mellitus |
1/1314 (0.08%) |
Musculoskeletal and connective tissue disorders |
|
Arthralgia |
2/1314 (0.15%) |
Arthritis |
1/1314 (0.08%) |
Back disorder |
1/1314 (0.08%) |
Back pain |
2/1314 (0.15%) |
Chondropathy |
1/1314 (0.08%) |
Costochondritis |
2/1314 (0.15%) |
Flank pain |
2/1314 (0.15%) |
Haemarthrosis |
1/1314 (0.08%) |
Joint effusion |
1/1314 (0.08%) |
Joint instability |
1/1314 (0.08%) |
Joint range of motion decreased |
1/1314 (0.08%) |
Muscle spasms |
1/1314 (0.08%) |
Muscular weakness |
2/1314 (0.15%) |
Musculoskeletal chest pain |
2/1314 (0.15%) |
Musculoskeletal stiffness |
1/1314 (0.08%) |
Osteoarthritis |
2/1314 (0.15%) |
Osteonecrosis |
2/1314 (0.15%) |
Pain in jaw |
1/1314 (0.08%) |
Plantar fasciitis |
1/1314 (0.08%) |
Rotator cuff syndrome |
1/1314 (0.08%) |
SAPHO syndrome |
1/1314 (0.08%) |
Spinal pain |
1/1314 (0.08%) |
Temporomandibular joint syndrome |
1/1314 (0.08%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
Anogenital warts |
3/1314 (0.23%) |
B-cell lymphoma |
1/1314 (0.08%) |
Basal cell carcinoma |
1/1314 (0.08%) |
Benign hydatidiform mole |
1/1314 (0.08%) |
Benign neoplasm of thyroid gland |
2/1314 (0.15%) |
Breast cancer |
2/1314 (0.15%) |
Castleman's disease |
1/1314 (0.08%) |
Cervix carcinoma stage II |
1/1314 (0.08%) |
Insulinoma |
1/1314 (0.08%) |
Invasive ductal breast carcinoma |
1/1314 (0.08%) |
Invasive lobular breast carcinoma |
1/1314 (0.08%) |
Malignant melanoma |
1/1314 (0.08%) |
Malignant melanoma in situ |
1/1314 (0.08%) |
Meningioma benign |
1/1314 (0.08%) |
Metastatic malignant melanoma |
1/1314 (0.08%) |
Neoplasm skin |
1/1314 (0.08%) |
Non-small cell lung cancer |
1/1314 (0.08%) |
Ovarian adenoma |
1/1314 (0.08%) |
Pancreatic neuroendocrine tumour |
1/1314 (0.08%) |
Papillary thyroid cancer |
3/1314 (0.23%) |
Parathyroid tumour benign |
1/1314 (0.08%) |
Pituitary tumour |
1/1314 (0.08%) |
Squamous cell carcinoma |
1/1314 (0.08%) |
Thyroid cancer |
1/1314 (0.08%) |
Uterine leiomyoma |
5/1314 (0.38%) |
Vulval cancer stage 0 |
1/1314 (0.08%) |
Nervous system disorders |
|
Altered state of consciousness |
1/1314 (0.08%) |
Basal ganglia haemorrhage |
1/1314 (0.08%) |
Cerebral haemorrhage |
2/1314 (0.15%) |
Complex partial seizures |
1/1314 (0.08%) |
Depressed level of consciousness |
1/1314 (0.08%) |
Dizziness |
2/1314 (0.15%) |
Dysarthria |
1/1314 (0.08%) |
Embolic stroke |
1/1314 (0.08%) |
Headache |
7/1314 (0.53%) |
Intracranial aneurysm |
1/1314 (0.08%) |
Intraventricular haemorrhage |
1/1314 (0.08%) |
Loss of consciousness |
2/1314 (0.15%) |
Migraine |
1/1314 (0.08%) |
Multiple sclerosis |
4/1314 (0.30%) |
Multiple sclerosis relapse |
67/1314 (5.10%) |
Optic neuritis |
1/1314 (0.08%) |
Seizure |
4/1314 (0.30%) |
Status epilepticus |
1/1314 (0.08%) |
Syncope |
9/1314 (0.68%) |
Tension headache |
1/1314 (0.08%) |
Tremor |
1/1314 (0.08%) |
Trigeminal neuralgia |
3/1314 (0.23%) |
Uhthoff's phenomenon |
6/1314 (0.46%) |
Pregnancy, puerperium and perinatal conditions |
|
Abortion |
1/1314 (0.08%) |
Abortion missed |
3/1314 (0.23%) |
Foetal cardiac disorder |
1/1314 (0.08%) |
Foetal death |
1/1314 (0.08%) |
Foetal-maternal haemorrhage |
1/1314 (0.08%) |
HELLP syndrome |
1/1314 (0.08%) |
Low birth weight baby |
1/1314 (0.08%) |
Peripartum cardiomyopathy |
1/1314 (0.08%) |
Placental insufficiency |
1/1314 (0.08%) |
Pre-eclampsia |
1/1314 (0.08%) |
Premature separation of placenta |
2/1314 (0.15%) |
Psychiatric disorders |
|
Adjustment disorder |
1/1314 (0.08%) |
Affective disorder |
1/1314 (0.08%) |
Bipolar II disorder |
1/1314 (0.08%) |
Completed suicide |
2/1314 (0.15%) |
Depression |
2/1314 (0.15%) |
Hypomania |
1/1314 (0.08%) |
Insomnia |
1/1314 (0.08%) |
Major depression |
1/1314 (0.08%) |
Mental status changes |
4/1314 (0.30%) |
Post-traumatic amnestic disorder |
1/1314 (0.08%) |
Psychogenic pain disorder |
1/1314 (0.08%) |
Psychogenic tremor |
1/1314 (0.08%) |
Psychotic disorder |
1/1314 (0.08%) |
Schizoaffective disorder bipolar type |
1/1314 (0.08%) |
Self injurious behaviour |
1/1314 (0.08%) |
Suicidal ideation |
6/1314 (0.46%) |
Suicide attempt |
1/1314 (0.08%) |
Renal and urinary disorders |
|
Acute kidney injury |
2/1314 (0.15%) |
Automatic bladder |
1/1314 (0.08%) |
Calculus bladder |
1/1314 (0.08%) |
Calculus ureteric |
1/1314 (0.08%) |
Glomerulonephritis |
1/1314 (0.08%) |
Glomerulonephritis membranous |
1/1314 (0.08%) |
Haematuria |
1/1314 (0.08%) |
Nephrolithiasis |
4/1314 (0.30%) |
Renal colic |
1/1314 (0.08%) |
Renal failure |
1/1314 (0.08%) |
Renal mass |
1/1314 (0.08%) |
Renal tubular necrosis |
1/1314 (0.08%) |
Urinary retention |
4/1314 (0.30%) |
Reproductive system and breast disorders |
|
Adnexa uteri mass |
1/1314 (0.08%) |
Cervical dysplasia |
4/1314 (0.30%) |
Cystocele |
2/1314 (0.15%) |
Endometrial hyperplasia |
1/1314 (0.08%) |
Endometriosis |
2/1314 (0.15%) |
Menometrorrhagia |
1/1314 (0.08%) |
Menorrhagia |
2/1314 (0.15%) |
Ovarian cyst |
6/1314 (0.46%) |
Ovarian haemorrhage |
1/1314 (0.08%) |
Parovarian cyst |
1/1314 (0.08%) |
Pelvic adhesions |
1/1314 (0.08%) |
Rectocele |
2/1314 (0.15%) |
Vaginal haemorrhage |
2/1314 (0.15%) |
Vulvar dysplasia |
1/1314 (0.08%) |
Respiratory, thoracic and mediastinal disorders |
|
Acute respiratory distress syndrome |
1/1314 (0.08%) |
Apnoea neonatal |
1/1314 (0.08%) |
Asthma |
2/1314 (0.15%) |
Bronchospasm |
1/1314 (0.08%) |
Chronic obstructive pulmonary disease |
1/1314 (0.08%) |
Dyspnoea |
3/1314 (0.23%) |
Eosinophilic pneumonia |
1/1314 (0.08%) |
Hiccups |
1/1314 (0.08%) |
Interstitial lung disease |
1/1314 (0.08%) |
Pleural effusion |
1/1314 (0.08%) |
Pleurisy |
2/1314 (0.15%) |
Pneumonia aspiration |
2/1314 (0.15%) |
Pneumonitis |
1/1314 (0.08%) |
Pneumothorax spontaneous |
1/1314 (0.08%) |
Pulmonary embolism |
2/1314 (0.15%) |
Respiratory failure |
1/1314 (0.08%) |
Sleep apnoea syndrome |
1/1314 (0.08%) |
Skin and subcutaneous tissue disorders |
|
Erythema nodosum |
1/1314 (0.08%) |
Hyperhidrosis |
1/1314 (0.08%) |
Polymorphic eruption of pregnancy |
1/1314 (0.08%) |
Rash |
1/1314 (0.08%) |
Rash generalised |
2/1314 (0.15%) |
Skin ulcer |
1/1314 (0.08%) |
Urticaria |
2/1314 (0.15%) |
Surgical and medical procedures |
|
Thyroidectomy |
1/1314 (0.08%) |
Vascular disorders |
|
Deep vein thrombosis |
4/1314 (0.30%) |
Haematoma |
1/1314 (0.08%) |
Hypertension |
3/1314 (0.23%) |
Hypertensive crisis |
1/1314 (0.08%) |
Hypotension |
1/1314 (0.08%) |
Orthostatic hypotension |
1/1314 (0.08%) |
Pallor |
1/1314 (0.08%) |
Peripheral arterial occlusive disease |
1/1314 (0.08%) |
Thrombophlebitis |
1/1314 (0.08%) |
Vasculitis |
1/1314 (0.08%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 18.1
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Alemtuzumab
|
|
Affected / at Risk (%) |
Total |
1225/1314 (93.23%) |
Cardiac disorders |
|
Tachycardia |
86/1314 (6.54%) |
Endocrine disorders |
|
Autoimmune thyroiditis |
67/1314 (5.10%) |
Basedow's disease |
165/1314 (12.56%) |
Hyperthyroidism |
142/1314 (10.81%) |
Hypothyroidism |
140/1314 (10.65%) |
Eye disorders |
|
Vision blurred |
75/1314 (5.71%) |
Gastrointestinal disorders |
|
Abdominal pain |
72/1314 (5.48%) |
Constipation |
104/1314 (7.91%) |
Diarrhoea |
170/1314 (12.94%) |
Dyspepsia |
71/1314 (5.40%) |
Nausea |
206/1314 (15.68%) |
Vomiting |
130/1314 (9.89%) |
General disorders |
|
Fatigue |
280/1314 (21.31%) |
Pain |
85/1314 (6.47%) |
Pyrexia |
228/1314 (17.35%) |
Infections and infestations |
|
Bronchitis |
133/1314 (10.12%) |
Gastroenteritis |
81/1314 (6.16%) |
Gastroenteritis viral |
85/1314 (6.47%) |
Herpes zoster |
123/1314 (9.36%) |
Influenza |
155/1314 (11.80%) |
Nasopharyngitis |
382/1314 (29.07%) |
Oral herpes |
78/1314 (5.94%) |
Pharyngitis |
68/1314 (5.18%) |
Sinusitis |
186/1314 (14.16%) |
Upper respiratory tract infection |
272/1314 (20.70%) |
Urinary tract infection |
360/1314 (27.40%) |
Injury, poisoning and procedural complications |
|
Contusion |
141/1314 (10.73%) |
Fall |
87/1314 (6.62%) |
Investigations |
|
Blood creatinine increased |
68/1314 (5.18%) |
Protein urine present |
78/1314 (5.94%) |
Metabolism and nutrition disorders |
|
Vitamin D deficiency |
83/1314 (6.32%) |
Musculoskeletal and connective tissue disorders |
|
Arthralgia |
216/1314 (16.44%) |
Back pain |
205/1314 (15.60%) |
Muscle spasms |
132/1314 (10.05%) |
Muscular weakness |
113/1314 (8.60%) |
Musculoskeletal pain |
75/1314 (5.71%) |
Myalgia |
80/1314 (6.09%) |
Pain in extremity |
189/1314 (14.38%) |
Nervous system disorders |
|
Dizziness |
130/1314 (9.89%) |
Headache |
437/1314 (33.26%) |
Hypoaesthesia |
176/1314 (13.39%) |
Multiple sclerosis |
70/1314 (5.33%) |
Multiple sclerosis relapse |
508/1314 (38.66%) |
Paraesthesia |
168/1314 (12.79%) |
Psychiatric disorders |
|
Anxiety |
133/1314 (10.12%) |
Depression |
154/1314 (11.72%) |
Insomnia |
231/1314 (17.58%) |
Renal and urinary disorders |
|
Haematuria |
92/1314 (7.00%) |
Proteinuria |
122/1314 (9.28%) |
Respiratory, thoracic and mediastinal disorders |
|
Cough |
127/1314 (9.67%) |
Oropharyngeal pain |
91/1314 (6.93%) |
Skin and subcutaneous tissue disorders |
|
Rash |
208/1314 (15.83%) |
Rash generalised |
110/1314 (8.37%) |
Urticaria |
96/1314 (7.31%) |
Vascular disorders |
|
Flushing |
79/1314 (6.01%) |
Hypertension |
92/1314 (7.00%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 18.1
|