Time Frame |
Baseline up to end of study (up to 52 weeks)
|
Adverse Event Reporting Description |
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety population.
|
|
Arm/Group Title
|
Rituximab-EU
|
PF-05280586
|
Arm/Group Description |
Participants received Rituximab-EU ...
|
Participants received PF-05280586 I...
|
Arm/Group Description |
Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
|
Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.
|
|
|
Rituximab-EU
|
PF-05280586
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
1/197 (0.51%) |
1/196 (0.51%) |
|
|
Rituximab-EU
|
PF-05280586
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
15/197 (7.61%) |
17/196 (8.67%) |
Cardiac disorders |
|
|
Angina unstable |
1/197 (0.51%) |
0/196 (0.00%) |
Atrial fibrillation |
0/197 (0.00%) |
1/196 (0.51%) |
Intracardiac thrombus |
1/197 (0.51%) |
0/196 (0.00%) |
Gastrointestinal disorders |
|
|
Abdominal pain |
0/197 (0.00%) |
1/196 (0.51%) |
Mesenteric artery stenosis |
0/197 (0.00%) |
1/196 (0.51%) |
Ileus |
0/197 (0.00%) |
1/196 (0.51%) |
Inguinal hernia |
1/197 (0.51%) |
0/196 (0.00%) |
General disorders |
|
|
Disease progression |
1/197 (0.51%) |
1/196 (0.51%) |
Non-cardiac chest pain |
1/197 (0.51%) |
0/196 (0.00%) |
Pyrexia |
0/197 (0.00%) |
1/196 (0.51%) |
Hepatobiliary disorders |
|
|
Cholelithiasis |
1/197 (0.51%) |
0/196 (0.00%) |
Immune system disorders |
|
|
Serum sickness |
1/197 (0.51%) |
0/196 (0.00%) |
Infections and infestations |
|
|
Appendicitis |
0/197 (0.00%) |
1/196 (0.51%) |
Clostridium difficile infection |
0/197 (0.00%) |
1/196 (0.51%) |
Diverticulitis |
0/197 (0.00%) |
1/196 (0.51%) |
Escherichia sepsis |
1/197 (0.51%) |
0/196 (0.00%) |
Hepatitis B |
1/197 (0.51%) |
0/196 (0.00%) |
Kidney infection |
1/197 (0.51%) |
0/196 (0.00%) |
Peritonitis |
0/197 (0.00%) |
1/196 (0.51%) |
Urinary tract infection |
0/197 (0.00%) |
1/196 (0.51%) |
Viral sinusitis |
1/197 (0.51%) |
0/196 (0.00%) |
Injury, poisoning and procedural complications |
|
|
Contusion |
0/197 (0.00%) |
1/196 (0.51%) |
Infusion related reaction |
1/197 (0.51%) |
0/196 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
Intervertebral disc disorder |
0/197 (0.00%) |
1/196 (0.51%) |
Polyarthritis |
1/197 (0.51%) |
0/196 (0.00%) |
Spinal column stenosis |
1/197 (0.51%) |
0/196 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Bladder cancer |
1/197 (0.51%) |
0/196 (0.00%) |
Lung adenocarcinoma stage I |
0/197 (0.00%) |
1/196 (0.51%) |
Prostate cancer |
0/197 (0.00%) |
1/196 (0.51%) |
Squamous cell carcinoma of lung |
1/197 (0.51%) |
0/196 (0.00%) |
Uterine cancer |
0/197 (0.00%) |
1/196 (0.51%) |
Colon adenoma |
0/197 (0.00%) |
1/196 (0.51%) |
Nervous system disorders |
|
|
Paraesthesia |
0/197 (0.00%) |
1/196 (0.51%) |
Transient ischaemic attack |
0/197 (0.00%) |
1/196 (0.51%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Dyspnoea |
1/197 (0.51%) |
0/196 (0.00%) |
Pulmonary embolism |
1/197 (0.51%) |
0/196 (0.00%) |
Term from vocabulary, MedDRA (v20.1)
Indicates events were collected by non-systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
Rituximab-EU
|
PF-05280586
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
143/197 (72.59%) |
153/196 (78.06%) |
Blood and lymphatic system disorders |
|
|
Anaemia |
1/197 (0.51%) |
1/196 (0.51%) |
Lymph node pain |
0/197 (0.00%) |
1/196 (0.51%) |
Lymphopenia |
1/197 (0.51%) |
1/196 (0.51%) |
Neutropenia |
3/197 (1.52%) |
1/196 (0.51%) |
Thrombocytopenia |
1/197 (0.51%) |
0/196 (0.00%) |
Cardiac disorders |
|
|
Angina pectoris |
1/197 (0.51%) |
0/196 (0.00%) |
Angina unstable |
1/197 (0.51%) |
0/196 (0.00%) |
Atrial fibrillation |
0/197 (0.00%) |
2/196 (1.02%) |
Bradycardia |
1/197 (0.51%) |
0/196 (0.00%) |
Cardiac failure congestive |
0/197 (0.00%) |
1/196 (0.51%) |
Palpitations |
2/197 (1.02%) |
5/196 (2.55%) |
Sinus bradycardia |
1/197 (0.51%) |
0/196 (0.00%) |
Tachycardia |
2/197 (1.02%) |
0/196 (0.00%) |
Ear and labyrinth disorders |
|
|
Ear discomfort |
0/197 (0.00%) |
2/196 (1.02%) |
Ear disorder |
0/197 (0.00%) |
1/196 (0.51%) |
Ear pain |
1/197 (0.51%) |
1/196 (0.51%) |
Ear pruritus |
2/197 (1.02%) |
3/196 (1.53%) |
Hypoacusis |
2/197 (1.02%) |
2/196 (1.02%) |
Tinnitus |
1/197 (0.51%) |
1/196 (0.51%) |
Vertigo |
3/197 (1.52%) |
2/196 (1.02%) |
Vertigo positional |
1/197 (0.51%) |
0/196 (0.00%) |
Endocrine disorders |
|
|
Hyperthyroidism |
1/197 (0.51%) |
0/196 (0.00%) |
Hypothyroidism |
2/197 (1.02%) |
0/196 (0.00%) |
Thyroid cyst |
0/197 (0.00%) |
1/196 (0.51%) |
Eye disorders |
|
|
Accommodation disorder |
0/197 (0.00%) |
1/196 (0.51%) |
Cataract |
1/197 (0.51%) |
2/196 (1.02%) |
Conjunctival disorder |
1/197 (0.51%) |
0/196 (0.00%) |
Diplopia |
1/197 (0.51%) |
0/196 (0.00%) |
Dry eye |
2/197 (1.02%) |
0/196 (0.00%) |
Erythema of eyelid |
0/197 (0.00%) |
1/196 (0.51%) |
Eye pruritus |
3/197 (1.52%) |
0/196 (0.00%) |
Lacrimation increased |
1/197 (0.51%) |
0/196 (0.00%) |
Meibomianitis |
1/197 (0.51%) |
0/196 (0.00%) |
Ocular hyperaemia |
1/197 (0.51%) |
0/196 (0.00%) |
Entropion |
0/197 (0.00%) |
1/196 (0.51%) |
Visual impairment |
0/197 (0.00%) |
1/196 (0.51%) |
Gastrointestinal disorders |
|
|
Abdominal discomfort |
1/197 (0.51%) |
1/196 (0.51%) |
Abdominal pain |
3/197 (1.52%) |
7/196 (3.57%) |
Abdominal pain lower |
0/197 (0.00%) |
1/196 (0.51%) |
Abdominal pain upper |
5/197 (2.54%) |
9/196 (4.59%) |
Cheilitis |
0/197 (0.00%) |
1/196 (0.51%) |
Chronic gastritis |
0/197 (0.00%) |
1/196 (0.51%) |
Colitis |
0/197 (0.00%) |
1/196 (0.51%) |
Constipation |
8/197 (4.06%) |
8/196 (4.08%) |
Dental caries |
0/197 (0.00%) |
2/196 (1.02%) |
Diarrhoea |
12/197 (6.09%) |
14/196 (7.14%) |
Diverticulum intestinal |
1/197 (0.51%) |
0/196 (0.00%) |
Dry mouth |
1/197 (0.51%) |
0/196 (0.00%) |
Dyspepsia |
2/197 (1.02%) |
5/196 (2.55%) |
Dysphagia |
1/197 (0.51%) |
0/196 (0.00%) |
Enterocolitis |
0/197 (0.00%) |
1/196 (0.51%) |
Faeces soft |
1/197 (0.51%) |
0/196 (0.00%) |
Flatulence |
0/197 (0.00%) |
1/196 (0.51%) |
Functional gastrointestinal disorder |
1/197 (0.51%) |
0/196 (0.00%) |
Gastritis |
0/197 (0.00%) |
1/196 (0.51%) |
Gastrointestinal disorder |
0/197 (0.00%) |
3/196 (1.53%) |
Gastrooesophageal reflux disease |
0/197 (0.00%) |
1/196 (0.51%) |
Gingival pain |
1/197 (0.51%) |
0/196 (0.00%) |
Gingival swelling |
0/197 (0.00%) |
1/196 (0.51%) |
Haematochezia |
1/197 (0.51%) |
0/196 (0.00%) |
Haemorrhoids |
2/197 (1.02%) |
0/196 (0.00%) |
Inguinal hernia |
1/197 (0.51%) |
0/196 (0.00%) |
Lip oedema |
1/197 (0.51%) |
0/196 (0.00%) |
Mouth swelling |
0/197 (0.00%) |
1/196 (0.51%) |
Nausea |
17/197 (8.63%) |
15/196 (7.65%) |
Odynophagia |
1/197 (0.51%) |
1/196 (0.51%) |
Oral discomfort |
0/197 (0.00%) |
1/196 (0.51%) |
Oral mucosal erythema |
0/197 (0.00%) |
1/196 (0.51%) |
Paraesthesia oral |
1/197 (0.51%) |
0/196 (0.00%) |
Periodontal disease |
1/197 (0.51%) |
0/196 (0.00%) |
Rectal haemorrhage |
0/197 (0.00%) |
1/196 (0.51%) |
Salivary gland pain |
0/197 (0.00%) |
1/196 (0.51%) |
Stomatitis |
3/197 (1.52%) |
0/196 (0.00%) |
Swollen tongue |
0/197 (0.00%) |
1/196 (0.51%) |
Tooth disorder |
0/197 (0.00%) |
1/196 (0.51%) |
Toothache |
2/197 (1.02%) |
2/196 (1.02%) |
Vomiting |
7/197 (3.55%) |
3/196 (1.53%) |
General disorders |
|
|
Asthenia |
13/197 (6.60%) |
9/196 (4.59%) |
Axillary pain |
1/197 (0.51%) |
0/196 (0.00%) |
Catheter site pain |
1/197 (0.51%) |
0/196 (0.00%) |
Catheter site related reaction |
1/197 (0.51%) |
0/196 (0.00%) |
Chest discomfort |
1/197 (0.51%) |
2/196 (1.02%) |
Chest pain |
3/197 (1.52%) |
2/196 (1.02%) |
Chills |
3/197 (1.52%) |
3/196 (1.53%) |
Discomfort |
1/197 (0.51%) |
0/196 (0.00%) |
Face oedema |
0/197 (0.00%) |
1/196 (0.51%) |
Facial pain |
1/197 (0.51%) |
0/196 (0.00%) |
Fatigue |
13/197 (6.60%) |
12/196 (6.12%) |
Feeling abnormal |
1/197 (0.51%) |
0/196 (0.00%) |
Feeling cold |
0/197 (0.00%) |
1/196 (0.51%) |
Feeling hot |
2/197 (1.02%) |
2/196 (1.02%) |
Generalised oedema |
0/197 (0.00%) |
2/196 (1.02%) |
Influenza like illness |
4/197 (2.03%) |
2/196 (1.02%) |
Infusion site bruising |
1/197 (0.51%) |
0/196 (0.00%) |
General physical health deterioration |
1/197 (0.51%) |
0/196 (0.00%) |
Infusion site erythema |
1/197 (0.51%) |
0/196 (0.00%) |
Infusion site extravasation |
1/197 (0.51%) |
0/196 (0.00%) |
Infusion site pain |
0/197 (0.00%) |
1/196 (0.51%) |
Malaise |
0/197 (0.00%) |
3/196 (1.53%) |
Non-cardiac chest pain |
1/197 (0.51%) |
1/196 (0.51%) |
Oedema |
1/197 (0.51%) |
2/196 (1.02%) |
Oedema peripheral |
7/197 (3.55%) |
2/196 (1.02%) |
Pain |
3/197 (1.52%) |
3/196 (1.53%) |
Peripheral swelling |
1/197 (0.51%) |
0/196 (0.00%) |
Pyrexia |
11/197 (5.58%) |
11/196 (5.61%) |
Suprapubic pain |
1/197 (0.51%) |
0/196 (0.00%) |
Swelling |
0/197 (0.00%) |
1/196 (0.51%) |
Hepatobiliary disorders |
|
|
Hepatic steatosis |
1/197 (0.51%) |
0/196 (0.00%) |
Hepatocellular injury |
0/197 (0.00%) |
1/196 (0.51%) |
Immune system disorders |
|
|
Contrast media allergy |
1/197 (0.51%) |
2/196 (1.02%) |
Cytokine release syndrome |
0/197 (0.00%) |
1/196 (0.51%) |
Drug hypersensitivity |
0/197 (0.00%) |
1/196 (0.51%) |
Hypersensitivity |
1/197 (0.51%) |
0/196 (0.00%) |
Hypogammaglobulinaemia |
1/197 (0.51%) |
0/196 (0.00%) |
Infections and infestations |
|
|
Acarodermatitis |
0/197 (0.00%) |
1/196 (0.51%) |
Acute sinusitis |
1/197 (0.51%) |
1/196 (0.51%) |
Atypical mycobacterial infection |
1/197 (0.51%) |
0/196 (0.00%) |
Bronchitis |
7/197 (3.55%) |
3/196 (1.53%) |
Cellulitis |
0/197 (0.00%) |
1/196 (0.51%) |
Conjunctivitis |
3/197 (1.52%) |
0/196 (0.00%) |
Cystitis |
3/197 (1.52%) |
1/196 (0.51%) |
Cystitis bacterial |
1/197 (0.51%) |
0/196 (0.00%) |
Diverticulitis |
0/197 (0.00%) |
1/196 (0.51%) |
Enteritis infectious |
1/197 (0.51%) |
0/196 (0.00%) |
Folliculitis |
1/197 (0.51%) |
0/196 (0.00%) |
Gastroenteritis |
3/197 (1.52%) |
2/196 (1.02%) |
Genital herpes |
0/197 (0.00%) |
1/196 (0.51%) |
Gingivitis |
1/197 (0.51%) |
0/196 (0.00%) |
Herpes zoster |
3/197 (1.52%) |
1/196 (0.51%) |
Infected bite |
1/197 (0.51%) |
0/196 (0.00%) |
Influenza |
6/197 (3.05%) |
4/196 (2.04%) |
Laryngitis |
1/197 (0.51%) |
0/196 (0.00%) |
Nasopharyngitis |
9/197 (4.57%) |
5/196 (2.55%) |
Oral herpes |
2/197 (1.02%) |
3/196 (1.53%) |
Otitis externa fungal |
1/197 (0.51%) |
0/196 (0.00%) |
Paronychia |
0/197 (0.00%) |
1/196 (0.51%) |
Pertussis |
1/197 (0.51%) |
0/196 (0.00%) |
Pharyngitis |
4/197 (2.03%) |
4/196 (2.04%) |
Pneumonia |
0/197 (0.00%) |
1/196 (0.51%) |
Purulence |
0/197 (0.00%) |
1/196 (0.51%) |
Respiratory tract infection |
1/197 (0.51%) |
3/196 (1.53%) |
Rhinitis |
3/197 (1.52%) |
1/196 (0.51%) |
Sinusitis |
2/197 (1.02%) |
5/196 (2.55%) |
Skin infection |
2/197 (1.02%) |
0/196 (0.00%) |
Sycosis barbae |
1/197 (0.51%) |
0/196 (0.00%) |
Systemic infection |
1/197 (0.51%) |
0/196 (0.00%) |
Tracheitis |
0/197 (0.00%) |
1/196 (0.51%) |
Trichophytosis |
1/197 (0.51%) |
0/196 (0.00%) |
Upper respiratory tract infection |
5/197 (2.54%) |
9/196 (4.59%) |
Urinary tract infection |
5/197 (2.54%) |
4/196 (2.04%) |
Viral infection |
0/197 (0.00%) |
1/196 (0.51%) |
Viral pharyngitis |
2/197 (1.02%) |
0/196 (0.00%) |
Viral upper respiratory tract infection |
1/197 (0.51%) |
0/196 (0.00%) |
Injury, poisoning and procedural complications |
|
|
Bone contusion |
0/197 (0.00%) |
1/196 (0.51%) |
Chest injury |
1/197 (0.51%) |
1/196 (0.51%) |
Contusion |
1/197 (0.51%) |
2/196 (1.02%) |
Fall |
2/197 (1.02%) |
5/196 (2.55%) |
Hand fracture |
1/197 (0.51%) |
0/196 (0.00%) |
Head injury |
2/197 (1.02%) |
0/196 (0.00%) |
Humerus fracture |
1/197 (0.51%) |
0/196 (0.00%) |
Infusion related reaction |
58/197 (29.44%) |
49/196 (25.00%) |
Laceration |
2/197 (1.02%) |
0/196 (0.00%) |
Limb injury |
0/197 (0.00%) |
2/196 (1.02%) |
Neck injury |
1/197 (0.51%) |
0/196 (0.00%) |
Post procedural haemorrhage |
0/197 (0.00%) |
1/196 (0.51%) |
Road traffic accident |
1/197 (0.51%) |
0/196 (0.00%) |
Skin abrasion |
0/197 (0.00%) |
1/196 (0.51%) |
Suture related complication |
1/197 (0.51%) |
0/196 (0.00%) |
Suture rupture |
1/197 (0.51%) |
0/196 (0.00%) |
Tendon rupture |
1/197 (0.51%) |
0/196 (0.00%) |
Thermal burn |
1/197 (0.51%) |
1/196 (0.51%) |
Upper limb fracture |
0/197 (0.00%) |
1/196 (0.51%) |
Wound complication |
2/197 (1.02%) |
0/196 (0.00%) |
Wrist fracture |
0/197 (0.00%) |
1/196 (0.51%) |
Incision site pain |
1/197 (0.51%) |
0/196 (0.00%) |
Procedural pain |
0/197 (0.00%) |
1/196 (0.51%) |
Investigations |
|
|
Alanine aminotransferase increased |
3/197 (1.52%) |
0/196 (0.00%) |
Aspartate aminotransferase increased |
1/197 (0.51%) |
1/196 (0.51%) |
Blood bilirubin increased |
1/197 (0.51%) |
0/196 (0.00%) |
Blood creatinine increased |
0/197 (0.00%) |
1/196 (0.51%) |
Blood glucose increased |
0/197 (0.00%) |
1/196 (0.51%) |
Blood lactate dehydrogenase increased |
1/197 (0.51%) |
3/196 (1.53%) |
Blood potassium increased |
1/197 (0.51%) |
0/196 (0.00%) |
Blood pressure decreased |
2/197 (1.02%) |
0/196 (0.00%) |
Blood pressure increased |
1/197 (0.51%) |
1/196 (0.51%) |
Blood thyroid stimulating hormone increased |
0/197 (0.00%) |
1/196 (0.51%) |
Blood urine present |
1/197 (0.51%) |
0/196 (0.00%) |
C-reactive protein increased |
1/197 (0.51%) |
0/196 (0.00%) |
Gamma-glutamyltransferase increased |
1/197 (0.51%) |
1/196 (0.51%) |
Lymphocyte count decreased |
1/197 (0.51%) |
1/196 (0.51%) |
Neutrophil count decreased |
0/197 (0.00%) |
5/196 (2.55%) |
Neutrophil count increased |
1/197 (0.51%) |
0/196 (0.00%) |
Serum ferritin decreased |
0/197 (0.00%) |
1/196 (0.51%) |
Weight decreased |
1/197 (0.51%) |
0/196 (0.00%) |
White blood cell count decreased |
1/197 (0.51%) |
4/196 (2.04%) |
Breath sounds abnormal |
1/197 (0.51%) |
1/196 (0.51%) |
Metabolism and nutrition disorders |
|
|
Decreased appetite |
1/197 (0.51%) |
2/196 (1.02%) |
Dehydration |
0/197 (0.00%) |
2/196 (1.02%) |
Diabetes mellitus |
0/197 (0.00%) |
2/196 (1.02%) |
Dyslipidaemia |
0/197 (0.00%) |
1/196 (0.51%) |
Fluid retention |
1/197 (0.51%) |
0/196 (0.00%) |
Hypercholesterolaemia |
1/197 (0.51%) |
1/196 (0.51%) |
Hyperglycaemia |
4/197 (2.03%) |
1/196 (0.51%) |
Hypertriglyceridaemia |
1/197 (0.51%) |
3/196 (1.53%) |
Hyperuricaemia |
2/197 (1.02%) |
0/196 (0.00%) |
Hypoglycaemia |
1/197 (0.51%) |
0/196 (0.00%) |
Hypokalaemia |
1/197 (0.51%) |
0/196 (0.00%) |
Type 2 diabetes mellitus |
1/197 (0.51%) |
1/196 (0.51%) |
Vitamin D deficiency |
1/197 (0.51%) |
1/196 (0.51%) |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
6/197 (3.05%) |
7/196 (3.57%) |
Back pain |
10/197 (5.08%) |
8/196 (4.08%) |
Bone loss |
0/197 (0.00%) |
1/196 (0.51%) |
Bone pain |
3/197 (1.52%) |
0/196 (0.00%) |
Costochondritis |
1/197 (0.51%) |
0/196 (0.00%) |
Flank pain |
2/197 (1.02%) |
1/196 (0.51%) |
Groin pain |
2/197 (1.02%) |
3/196 (1.53%) |
Haemarthrosis |
1/197 (0.51%) |
0/196 (0.00%) |
Intervertebral disc protrusion |
1/197 (0.51%) |
0/196 (0.00%) |
Joint effusion |
1/197 (0.51%) |
0/196 (0.00%) |
Joint stiffness |
1/197 (0.51%) |
1/196 (0.51%) |
Joint swelling |
1/197 (0.51%) |
1/196 (0.51%) |
Muscle contracture |
0/197 (0.00%) |
1/196 (0.51%) |
Muscle spasms |
1/197 (0.51%) |
0/196 (0.00%) |
Muscle twitching |
0/197 (0.00%) |
1/196 (0.51%) |
Muscular weakness |
2/197 (1.02%) |
1/196 (0.51%) |
Musculoskeletal chest pain |
1/197 (0.51%) |
0/196 (0.00%) |
Musculoskeletal discomfort |
0/197 (0.00%) |
2/196 (1.02%) |
Musculoskeletal pain |
2/197 (1.02%) |
1/196 (0.51%) |
Musculoskeletal stiffness |
2/197 (1.02%) |
2/196 (1.02%) |
Myalgia |
5/197 (2.54%) |
9/196 (4.59%) |
Neck pain |
3/197 (1.52%) |
2/196 (1.02%) |
Osteoarthritis |
1/197 (0.51%) |
0/196 (0.00%) |
Pain in extremity |
4/197 (2.03%) |
7/196 (3.57%) |
Posture abnormal |
1/197 (0.51%) |
0/196 (0.00%) |
Pubic pain |
1/197 (0.51%) |
0/196 (0.00%) |
Spinal osteoarthritis |
1/197 (0.51%) |
0/196 (0.00%) |
Spinal pain |
2/197 (1.02%) |
2/196 (1.02%) |
Spondylolisthesis |
1/197 (0.51%) |
0/196 (0.00%) |
Tendon calcification |
0/197 (0.00%) |
1/196 (0.51%) |
Tendonitis |
1/197 (0.51%) |
1/196 (0.51%) |
Periarthritis |
1/197 (0.51%) |
0/196 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Basal cell carcinoma |
2/197 (1.02%) |
1/196 (0.51%) |
Infected neoplasm |
1/197 (0.51%) |
0/196 (0.00%) |
Lung adenocarcinoma stage I |
0/197 (0.00%) |
1/196 (0.51%) |
Meningioma |
0/197 (0.00%) |
1/196 (0.51%) |
Non-Hodgkin's lymphoma |
0/197 (0.00%) |
1/196 (0.51%) |
Nervous system disorders |
|
|
Burning sensation |
1/197 (0.51%) |
1/196 (0.51%) |
Dizziness |
6/197 (3.05%) |
2/196 (1.02%) |
Dysgeusia |
1/197 (0.51%) |
0/196 (0.00%) |
Head discomfort |
0/197 (0.00%) |
1/196 (0.51%) |
Headache |
19/197 (9.64%) |
16/196 (8.16%) |
Hypoaesthesia |
1/197 (0.51%) |
1/196 (0.51%) |
Hypotonia |
0/197 (0.00%) |
1/196 (0.51%) |
Intercostal neuralgia |
0/197 (0.00%) |
1/196 (0.51%) |
Lethargy |
0/197 (0.00%) |
1/196 (0.51%) |
Migraine |
0/197 (0.00%) |
1/196 (0.51%) |
Nerve compression |
0/197 (0.00%) |
1/196 (0.51%) |
Neuralgia |
1/197 (0.51%) |
0/196 (0.00%) |
Neuropathy peripheral |
1/197 (0.51%) |
1/196 (0.51%) |
Paraesthesia |
3/197 (1.52%) |
2/196 (1.02%) |
Polyneuropathy |
0/197 (0.00%) |
1/196 (0.51%) |
Presyncope |
1/197 (0.51%) |
0/196 (0.00%) |
Restless legs syndrome |
1/197 (0.51%) |
3/196 (1.53%) |
Somnolence |
3/197 (1.52%) |
2/196 (1.02%) |
Speech disorder |
1/197 (0.51%) |
0/196 (0.00%) |
Syncope |
0/197 (0.00%) |
1/196 (0.51%) |
Tension headache |
1/197 (0.51%) |
0/196 (0.00%) |
Psychiatric disorders |
|
|
Affect lability |
0/197 (0.00%) |
1/196 (0.51%) |
Agitation |
1/197 (0.51%) |
0/196 (0.00%) |
Anxiety |
7/197 (3.55%) |
6/196 (3.06%) |
Confusional state |
1/197 (0.51%) |
0/196 (0.00%) |
Depression |
2/197 (1.02%) |
3/196 (1.53%) |
Gastrointestinal somatic symptom disorder |
0/197 (0.00%) |
1/196 (0.51%) |
Insomnia |
8/197 (4.06%) |
5/196 (2.55%) |
Irritability |
1/197 (0.51%) |
1/196 (0.51%) |
Panic attack |
0/197 (0.00%) |
1/196 (0.51%) |
Restlessness |
1/197 (0.51%) |
0/196 (0.00%) |
Renal and urinary disorders |
|
|
Bladder spasm |
0/197 (0.00%) |
1/196 (0.51%) |
Calculus bladder |
1/197 (0.51%) |
0/196 (0.00%) |
Dysuria |
1/197 (0.51%) |
2/196 (1.02%) |
Nocturia |
0/197 (0.00%) |
1/196 (0.51%) |
Pollakiuria |
1/197 (0.51%) |
0/196 (0.00%) |
Renal pain |
1/197 (0.51%) |
0/196 (0.00%) |
Strangury |
1/197 (0.51%) |
0/196 (0.00%) |
Urinary retention |
1/197 (0.51%) |
0/196 (0.00%) |
Urinary tract pain |
0/197 (0.00%) |
1/196 (0.51%) |
Reproductive system and breast disorders |
|
|
Benign prostatic hyperplasia |
1/197 (0.51%) |
0/196 (0.00%) |
Breast pain |
1/197 (0.51%) |
0/196 (0.00%) |
Breast tenderness |
0/197 (0.00%) |
1/196 (0.51%) |
Genital burning sensation |
0/197 (0.00%) |
1/196 (0.51%) |
Menorrhagia |
1/197 (0.51%) |
1/196 (0.51%) |
Metrorrhagia |
1/197 (0.51%) |
0/196 (0.00%) |
Ovarian cyst |
1/197 (0.51%) |
0/196 (0.00%) |
Pelvic pain |
1/197 (0.51%) |
1/196 (0.51%) |
Prostatitis |
1/197 (0.51%) |
0/196 (0.00%) |
Scrotal pain |
0/197 (0.00%) |
1/196 (0.51%) |
Testicular pain |
0/197 (0.00%) |
1/196 (0.51%) |
Vaginal haemorrhage |
0/197 (0.00%) |
3/196 (1.53%) |
Vulvovaginal inflammation |
0/197 (0.00%) |
1/196 (0.51%) |
Vulvovaginal pain |
0/197 (0.00%) |
1/196 (0.51%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Bronchospasm |
1/197 (0.51%) |
0/196 (0.00%) |
Cough |
11/197 (5.58%) |
11/196 (5.61%) |
Dry throat |
1/197 (0.51%) |
2/196 (1.02%) |
Dysphonia |
2/197 (1.02%) |
0/196 (0.00%) |
Dyspnoea |
8/197 (4.06%) |
6/196 (3.06%) |
Dyspnoea exertional |
1/197 (0.51%) |
0/196 (0.00%) |
Emphysema |
1/197 (0.51%) |
0/196 (0.00%) |
Epistaxis |
1/197 (0.51%) |
1/196 (0.51%) |
Hiccups |
0/197 (0.00%) |
1/196 (0.51%) |
Hyperventilation |
0/197 (0.00%) |
1/196 (0.51%) |
Laryngeal discomfort |
1/197 (0.51%) |
0/196 (0.00%) |
Laryngeal inflammation |
1/197 (0.51%) |
0/196 (0.00%) |
Laryngeal oedema |
2/197 (1.02%) |
0/196 (0.00%) |
Laryngeal pain |
1/197 (0.51%) |
0/196 (0.00%) |
Lung disorder |
1/197 (0.51%) |
0/196 (0.00%) |
Nasal congestion |
1/197 (0.51%) |
2/196 (1.02%) |
Nasal discomfort |
1/197 (0.51%) |
1/196 (0.51%) |
Nasal pruritus |
1/197 (0.51%) |
0/196 (0.00%) |
Oropharyngeal discomfort |
1/197 (0.51%) |
4/196 (2.04%) |
Oropharyngeal pain |
10/197 (5.08%) |
2/196 (1.02%) |
Paranasal sinus mucosal hypertrophy |
1/197 (0.51%) |
1/196 (0.51%) |
Pharyngeal erythema |
0/197 (0.00%) |
2/196 (1.02%) |
Pharyngeal inflammation |
0/197 (0.00%) |
1/196 (0.51%) |
Pharyngeal oedema |
1/197 (0.51%) |
1/196 (0.51%) |
Pharyngeal paraesthesia |
1/197 (0.51%) |
2/196 (1.02%) |
Productive cough |
1/197 (0.51%) |
2/196 (1.02%) |
Pulmonary embolism |
1/197 (0.51%) |
1/196 (0.51%) |
Respiratory disorder |
1/197 (0.51%) |
1/196 (0.51%) |
Rhinalgia |
1/197 (0.51%) |
0/196 (0.00%) |
Rhinitis allergic |
0/197 (0.00%) |
1/196 (0.51%) |
Rhinorrhoea |
1/197 (0.51%) |
0/196 (0.00%) |
Sleep apnoea syndrome |
1/197 (0.51%) |
0/196 (0.00%) |
Suffocation feeling |
1/197 (0.51%) |
0/196 (0.00%) |
Throat tightness |
1/197 (0.51%) |
0/196 (0.00%) |
Tonsillar disorder |
1/197 (0.51%) |
0/196 (0.00%) |
Tonsillar erythema |
0/197 (0.00%) |
1/196 (0.51%) |
Tonsillar hypertrophy |
1/197 (0.51%) |
0/196 (0.00%) |
Upper respiratory tract inflammation |
3/197 (1.52%) |
1/196 (0.51%) |
Upper-airway cough syndrome |
0/197 (0.00%) |
1/196 (0.51%) |
Sinus disorder |
0/197 (0.00%) |
1/196 (0.51%) |
Sneezing |
0/197 (0.00%) |
1/196 (0.51%) |
Throat irritation |
10/197 (5.08%) |
14/196 (7.14%) |
Skin and subcutaneous tissue disorders |
|
|
Acne |
0/197 (0.00%) |
1/196 (0.51%) |
Angioedema |
0/197 (0.00%) |
1/196 (0.51%) |
Asteatosis |
1/197 (0.51%) |
0/196 (0.00%) |
Blister |
1/197 (0.51%) |
0/196 (0.00%) |
Dermatitis |
0/197 (0.00%) |
1/196 (0.51%) |
Dermatitis allergic |
1/197 (0.51%) |
0/196 (0.00%) |
Dermatitis contact |
1/197 (0.51%) |
1/196 (0.51%) |
Drug eruption |
1/197 (0.51%) |
0/196 (0.00%) |
Dry skin |
0/197 (0.00%) |
1/196 (0.51%) |
Eczema |
3/197 (1.52%) |
1/196 (0.51%) |
Erythema |
2/197 (1.02%) |
7/196 (3.57%) |
Hyperhidrosis |
3/197 (1.52%) |
2/196 (1.02%) |
Hyperkeratosis |
0/197 (0.00%) |
1/196 (0.51%) |
Intertrigo |
0/197 (0.00%) |
1/196 (0.51%) |
Nail disorder |
0/197 (0.00%) |
1/196 (0.51%) |
Neurodermatitis |
1/197 (0.51%) |
0/196 (0.00%) |
Night sweats |
1/197 (0.51%) |
0/196 (0.00%) |
Pruritus allergic |
0/197 (0.00%) |
1/196 (0.51%) |
Rash |
8/197 (4.06%) |
10/196 (5.10%) |
Rash erythematous |
0/197 (0.00%) |
1/196 (0.51%) |
Rash maculo-papular |
0/197 (0.00%) |
1/196 (0.51%) |
Rash pruritic |
0/197 (0.00%) |
2/196 (1.02%) |
Scab |
0/197 (0.00%) |
1/196 (0.51%) |
Seborrhoeic dermatitis |
1/197 (0.51%) |
0/196 (0.00%) |
Skin burning sensation |
1/197 (0.51%) |
0/196 (0.00%) |
Skin lesion |
2/197 (1.02%) |
1/196 (0.51%) |
Swelling face |
1/197 (0.51%) |
0/196 (0.00%) |
Urticaria |
6/197 (3.05%) |
3/196 (1.53%) |
Pruritus |
22/197 (11.17%) |
13/196 (6.63%) |
Pruritus generalised |
0/197 (0.00%) |
1/196 (0.51%) |
Scar pain |
1/197 (0.51%) |
0/196 (0.00%) |
Social circumstances |
|
|
Menopause |
0/106 (0.00%) |
1/110 (0.91%) |
Vascular disorders |
|
|
Deep vein thrombosis |
2/197 (1.02%) |
0/196 (0.00%) |
Flushing |
4/197 (2.03%) |
1/196 (0.51%) |
Hot flush |
2/197 (1.02%) |
1/196 (0.51%) |
Hypertension |
7/197 (3.55%) |
5/196 (2.55%) |
Hypotension |
1/197 (0.51%) |
2/196 (1.02%) |
Lymphoedema |
0/197 (0.00%) |
1/196 (0.51%) |
Haematoma |
0/197 (0.00%) |
1/196 (0.51%) |
Term from vocabulary, MedDRA (v20.1)
Indicates events were collected by non-systematic assessment
|