Trial Outcomes & Findings for A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (NCT NCT01936181)
NCT ID: NCT01936181
Last Updated: 2017-09-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
584 participants
Primary outcome timeframe
Week 30
Results posted on
2017-09-14
Participant Flow
Participant milestones
| Measure |
SB2 (Proposed Biosimilar to Inflixmab)
SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
SB2 (proposed biosimilar to infliximab)
|
Remicade (Infliximab)
Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70.
|
Remicade (Infliximab), Switch to SB2
SB2 3mg/kg at week 54, 62, 70
SB2 (proposed biosimilar to infliximab)
|
Remicade (Infliximab), Continue as Remicade
Remicade 3mg/kg at week 54, 62, 70
Remicade (infliximab)
|
|---|---|---|---|---|
|
Randomised, Double-blind
STARTED
|
291
|
293
|
0
|
0
|
|
Randomised, Double-blind
COMPLETED
|
227
|
225
|
0
|
0
|
|
Randomised, Double-blind
NOT COMPLETED
|
64
|
68
|
0
|
0
|
|
Transition-extension
STARTED
|
201
|
0
|
94
|
101
|
|
Transition-extension
COMPLETED
|
186
|
0
|
88
|
96
|
|
Transition-extension
NOT COMPLETED
|
15
|
0
|
6
|
5
|
Reasons for withdrawal
| Measure |
SB2 (Proposed Biosimilar to Inflixmab)
SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
SB2 (proposed biosimilar to infliximab)
|
Remicade (Infliximab)
Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70.
|
Remicade (Infliximab), Switch to SB2
SB2 3mg/kg at week 54, 62, 70
SB2 (proposed biosimilar to infliximab)
|
Remicade (Infliximab), Continue as Remicade
Remicade 3mg/kg at week 54, 62, 70
Remicade (infliximab)
|
|---|---|---|---|---|
|
Randomised, Double-blind
Adverse Event
|
27
|
21
|
0
|
0
|
|
Randomised, Double-blind
Protocol Violation
|
1
|
5
|
0
|
0
|
|
Randomised, Double-blind
Lack of Efficacy
|
5
|
6
|
0
|
0
|
|
Randomised, Double-blind
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Randomised, Double-blind
Pregnancy
|
0
|
1
|
0
|
0
|
|
Randomised, Double-blind
Physician Decision
|
4
|
4
|
0
|
0
|
|
Randomised, Double-blind
Withdrawal by Subject
|
23
|
26
|
0
|
0
|
|
Randomised, Double-blind
Subjects from Eastern Ukraine sites
|
4
|
4
|
0
|
0
|
|
Transition-extension
Adverse Event
|
3
|
0
|
3
|
1
|
|
Transition-extension
Lost to Follow-up
|
3
|
0
|
1
|
2
|
|
Transition-extension
Physician Decision
|
2
|
0
|
0
|
1
|
|
Transition-extension
Withdrawal by Subject
|
7
|
0
|
2
|
1
|
Baseline Characteristics
A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Baseline characteristics by cohort
| Measure |
SB2 (Proposed Biosimilar to Inflixmab)
n=291 Participants
SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
SB2 (proposed biosimilar to infliximab)
|
Remicade (Infliximab)
n=293 Participants
Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70.
|
Total
n=584 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 11.92 • n=5 Participants
|
52.6 years
STANDARD_DEVIATION 11.74 • n=7 Participants
|
52.1 years
STANDARD_DEVIATION 11.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
232 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
468 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 30Outcome measures
| Measure |
SB2 (Proposed Biosimilar to Inflixmab)
n=231 Participants
SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
SB2 (proposed biosimilar to infliximab)
|
Remicade (Infliximab)
n=247 Participants
Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70.
|
SB2 at Week 78
SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
SB2 (proposed biosimilar to infliximab)
|
Remicade (Infliximab), Switch to SB2 at Week 78
Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised to be transitioned to SB2 (Remicade/SB2) up to Week 70 and received SB2 3mg/kg at week 54, 62, 70.
SB2 (proposed biosimilar to infliximab)
|
Remicade (Infliximab), Continue as Remicade
Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised to continue on Remicade (Remicade/Remicade) up to Week 70 and received Remicade 3mg/kg at week 54, 62, 70.
|
|---|---|---|---|---|---|
|
American College of Rheumatology 20% Response Criteria (ACR20)
|
64.1 percentage of participants
|
66.0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 54, Week 78Outcome measures
| Measure |
SB2 (Proposed Biosimilar to Inflixmab)
n=202 Participants
SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
SB2 (proposed biosimilar to infliximab)
|
Remicade (Infliximab)
n=208 Participants
Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70.
|
SB2 at Week 78
n=180 Participants
SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
SB2 (proposed biosimilar to infliximab)
|
Remicade (Infliximab), Switch to SB2 at Week 78
n=85 Participants
Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised to be transitioned to SB2 (Remicade/SB2) up to Week 70 and received SB2 3mg/kg at week 54, 62, 70.
SB2 (proposed biosimilar to infliximab)
|
Remicade (Infliximab), Continue as Remicade
n=93 Participants
Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised to continue on Remicade (Remicade/Remicade) up to Week 70 and received Remicade 3mg/kg at week 54, 62, 70.
|
|---|---|---|---|---|---|
|
ACR20
|
65.3 percentage of participants
|
69.2 percentage of participants
|
68.3 percentage of participants
|
63.5 percentage of participants
|
68.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 30, Week 54, Week 78Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 30, Week 54, Week 78Outcome measures
Outcome data not reported
Adverse Events
SB2 (Proposed Biosimilar to Inflixmab)
Serious events: 36 serious events
Other events: 201 other events
Deaths: 0 deaths
Remicade (Infliximab)
Serious events: 38 serious events
Other events: 203 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SB2 (Proposed Biosimilar to Inflixmab)
n=290 participants at risk
SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
SB2 (proposed biosimilar to infliximab)
|
Remicade (Infliximab)
n=293 participants at risk
Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Cardiac disorders
Angina Unstable
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Cardiac disorders
Atrial Fibrillation
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Cardiac disorders
Myocardial Infarction
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Cardiac disorders
Left Ventricular Failure
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Gastrointestinal disorders
Ileus Paralytic
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Gastrointestinal disorders
Abdominal Wall Haemorrhage
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Ileal Perforation
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Peptic Ulcer Haemorrhage
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Salivary Gland Calculus
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
General disorders
Device Damage
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Immune system disorders
Anaphylactic Reaction
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Immune system disorders
Hypersensitivity
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Immune system disorders
Anaphylactic Shock
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.0%
3/290 • Number of events 3
|
0.68%
2/293 • Number of events 2
|
|
Infections and infestations
Appendicitis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Bronchitis
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Pneumonia Bacterial
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Pseudomembranous Colitis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Pyelonephritis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Soft Tissue Infection
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Tuberculous Pleurisy
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Urinary Tract Infection
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Urosepsis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Arthritis Bacterial
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Diabetic Foot Infection
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Erysipelas
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Haematoma Infection
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Wound Infection
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Periprosthetic Fracture
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
1.4%
4/290 • Number of events 4
|
1.4%
4/293 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Lung Neoplasm
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Salivary Gland Neoplasm
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip And/Or Oral Cavity Cancer
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Reproductive system and breast disorders
Endometriosis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Reproductive system and breast disorders
Ovarian Cyst Torsion
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
Other adverse events
| Measure |
SB2 (Proposed Biosimilar to Inflixmab)
n=290 participants at risk
SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
SB2 (proposed biosimilar to infliximab)
|
Remicade (Infliximab)
n=293 participants at risk
Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70.
|
|---|---|---|
|
Investigations
Weight Increased
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.34%
1/290 • Number of events 1
|
0.68%
2/293 • Number of events 2
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Metabolism and nutrition disorders
Gout
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.34%
1/290 • Number of events 1
|
0.68%
2/293 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.4%
4/290 • Number of events 5
|
1.4%
4/293 • Number of events 4
|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
3/290 • Number of events 3
|
0.68%
2/293 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.0%
3/290 • Number of events 4
|
0.68%
2/293 • Number of events 2
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.69%
2/290 • Number of events 2
|
0.34%
1/293 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.69%
2/290 • Number of events 2
|
1.0%
3/293 • Number of events 4
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Blood and lymphatic system disorders
Anaemia Of Chronic Disease
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/290
|
1.4%
4/293 • Number of events 5
|
|
Cardiac disorders
Coronary Artery Disease
|
0.69%
2/290 • Number of events 2
|
0.34%
1/293 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.69%
2/290 • Number of events 2
|
0.34%
1/293 • Number of events 1
|
|
Cardiac disorders
Angina Unstable
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Cardiac disorders
Atrial Fibrillation
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Cardiac disorders
Hypertensive Cardiomyopathy
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Cardiac disorders
Myocardial Infarction
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/290
|
0.68%
2/293 • Number of events 3
|
|
Cardiac disorders
Left Ventricular Failure
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Ear and labyrinth disorders
Vertigo
|
0.34%
1/290 • Number of events 1
|
0.68%
2/293 • Number of events 2
|
|
Ear and labyrinth disorders
Hearing Impaired
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Endocrine disorders
Goitre
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Eye disorders
Cataract
|
1.0%
3/290 • Number of events 3
|
0.00%
0/293
|
|
Eye disorders
Conjunctivitis
|
0.69%
2/290 • Number of events 2
|
2.0%
6/293 • Number of events 6
|
|
Eye disorders
Eye Pruritus
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Eye disorders
Dry Eye
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Eye disorders
Eyelid Exfoliation
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Eye disorders
Eyelid Oedema
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Eye disorders
Keratitis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Eye disorders
Lacrimation Increased
|
0.34%
1/290 • Number of events 2
|
0.00%
0/293
|
|
Eye disorders
Myopia
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Eye disorders
Ocular Hyperaemia
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Eye disorders
Presbyopia
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Eye disorders
Retinopathy Hypertensive
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Eye disorders
Visual Impairment
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Eye disorders
Erythema Of Eyelid
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.1%
6/290 • Number of events 6
|
1.4%
4/293 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.7%
5/290 • Number of events 7
|
2.0%
6/293 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.0%
3/290 • Number of events 4
|
1.0%
3/293 • Number of events 3
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
1.0%
3/290 • Number of events 3
|
1.4%
4/293 • Number of events 4
|
|
Gastrointestinal disorders
Toothache
|
1.0%
3/290 • Number of events 4
|
0.00%
0/293
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Gastrointestinal disorders
Constipation
|
0.69%
2/290 • Number of events 2
|
0.68%
2/293 • Number of events 3
|
|
Gastrointestinal disorders
Enterocolitis
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.69%
2/290 • Number of events 2
|
0.68%
2/293 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.69%
2/290 • Number of events 2
|
1.0%
3/293 • Number of events 3
|
|
Gastrointestinal disorders
Dental Caries
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Gastrointestinal disorders
Diarrhoea
|
0.34%
1/290 • Number of events 1
|
1.4%
4/293 • Number of events 4
|
|
Gastrointestinal disorders
Diverticulum
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Gastrointestinal disorders
Dyspepsia
|
0.34%
1/290 • Number of events 3
|
2.4%
7/293 • Number of events 7
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.34%
1/290 • Number of events 2
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Food Poisoning
|
0.34%
1/290 • Number of events 2
|
0.00%
0/293
|
|
Gastrointestinal disorders
Gastric Polyps
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Gastrointestinal disorders
Gastritis
|
0.34%
1/290 • Number of events 1
|
1.0%
3/293 • Number of events 3
|
|
Gastrointestinal disorders
Glossodynia
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.34%
1/290 • Number of events 2
|
0.00%
0/293
|
|
Gastrointestinal disorders
Ileus Paralytic
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Gastrointestinal disorders
Submaxillary Gland Enlargement
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Wall Haemorrhage
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis Atrophic
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Inflammation
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Ischaemia
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Gastrointestinal disorders
Ileal Perforation
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Peptic Ulcer Haemorrhage
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Gastrointestinal disorders
Salivary Gland Calculus
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
General disorders
Fatigue
|
1.4%
4/290 • Number of events 4
|
0.34%
1/293 • Number of events 1
|
|
General disorders
Chest Discomfort
|
1.0%
3/290 • Number of events 3
|
0.00%
0/293
|
|
General disorders
Chest Pain
|
1.0%
3/290 • Number of events 7
|
0.34%
1/293 • Number of events 1
|
|
General disorders
Chills
|
1.0%
3/290 • Number of events 3
|
1.0%
3/293 • Number of events 5
|
|
General disorders
Oedema Peripheral
|
1.0%
3/290 • Number of events 3
|
1.4%
4/293 • Number of events 4
|
|
General disorders
Pyrexia
|
1.0%
3/290 • Number of events 3
|
3.1%
9/293 • Number of events 11
|
|
General disorders
Spinal Pain
|
0.69%
2/290 • Number of events 2
|
0.34%
1/293 • Number of events 1
|
|
General disorders
Asthenia
|
0.34%
1/290 • Number of events 1
|
0.68%
2/293 • Number of events 2
|
|
General disorders
Device Damage
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
General disorders
Face Oedema
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
General disorders
Influenza Like Illness
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
General disorders
Injection Site Hypersensitivity
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
General disorders
Injection Site Pruritus
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
General disorders
Local Swelling
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
General disorders
Malaise
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
General disorders
Nodule
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
General disorders
Thirst
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
General disorders
Feeling Cold
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
General disorders
Hernia
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
General disorders
Impaired Healing
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
General disorders
Injection Site Rash
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
General disorders
Irritability
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Hepatobiliary disorders
Biliary Colic
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Hepatobiliary disorders
Hepatitis Toxic
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Hepatobiliary disorders
Liver Disorder
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Hepatobiliary disorders
Drug-Induced Liver Injury
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic Pain
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
1.0%
3/290 • Number of events 3
|
1.0%
3/293 • Number of events 3
|
|
Immune system disorders
Allergy To Arthropod Sting
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Immune system disorders
Anaphylactic Reaction
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Immune system disorders
Anaphylactic Shock
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Immune system disorders
Food Allergy
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
9.0%
26/290 • Number of events 34
|
8.5%
25/293 • Number of events 34
|
|
Infections and infestations
Latent Tuberculosis
|
8.3%
24/290 • Number of events 31
|
9.2%
27/293 • Number of events 33
|
|
Infections and infestations
Bronchitis
|
4.5%
13/290 • Number of events 15
|
5.1%
15/293 • Number of events 18
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.5%
13/290 • Number of events 15
|
6.1%
18/293 • Number of events 31
|
|
Infections and infestations
Urinary Tract Infection
|
2.8%
8/290 • Number of events 8
|
2.4%
7/293 • Number of events 7
|
|
Infections and infestations
Pneumonia
|
2.4%
7/290 • Number of events 7
|
2.7%
8/293 • Number of events 8
|
|
Infections and infestations
Pharyngitis
|
2.1%
6/290 • Number of events 7
|
3.1%
9/293 • Number of events 12
|
|
Infections and infestations
Cystitis
|
1.0%
3/290 • Number of events 3
|
1.4%
4/293 • Number of events 4
|
|
Infections and infestations
Herpes Zoster
|
1.0%
3/290 • Number of events 3
|
0.68%
2/293 • Number of events 2
|
|
Infections and infestations
Influenza
|
1.0%
3/290 • Number of events 3
|
1.4%
4/293 • Number of events 6
|
|
Infections and infestations
Respiratory Tract Infection
|
1.0%
3/290 • Number of events 3
|
0.68%
2/293 • Number of events 2
|
|
Infections and infestations
Rhinitis
|
1.0%
3/290 • Number of events 3
|
1.7%
5/293 • Number of events 5
|
|
Infections and infestations
Sinusitis
|
1.0%
3/290 • Number of events 3
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Herpes Virus Infection
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Infections and infestations
Oral Herpes
|
0.69%
2/290 • Number of events 3
|
1.0%
3/293 • Number of events 6
|
|
Infections and infestations
Periodontitis
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Infections and infestations
Pulpitis Dental
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Infections and infestations
Acute Tonsillitis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Appendicitis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Laryngitis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Onychomycosis
|
0.34%
1/290 • Number of events 2
|
0.68%
2/293 • Number of events 2
|
|
Infections and infestations
Paronychia
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Parotitis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Pneumonia Bacterial
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Pseudomembranous Colitis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Pyelonephritis
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Pyelonephritis Chronic
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Schistosomiasis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Soft Tissue Infection
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Tonsillitis
|
0.34%
1/290 • Number of events 1
|
2.4%
7/293 • Number of events 13
|
|
Infections and infestations
Tooth Abscess
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Tuberculous Pleurisy
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Urosepsis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Infections and infestations
Viral Infection
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.34%
1/290 • Number of events 1
|
1.7%
5/293 • Number of events 6
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Arthritis Bacterial
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Atypical Mycobacterial Pneumonia
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Infections and infestations
Dacryocystitis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Diabetic Foot Infection
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Ear Infection
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Erysipelas
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Furuncle
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Infections and infestations
Gingivitis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Haematoma Infection
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Lyme Disease
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Otitis Media
|
0.00%
0/290
|
1.0%
3/293 • Number of events 4
|
|
Infections and infestations
Otitis Media Acute
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Peritonitis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Pharyngitis Bacterial
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/290
|
1.0%
3/293 • Number of events 3
|
|
Infections and infestations
Sepsis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Tracheitis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Infections and infestations
Wound Infection
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
1.0%
3/290 • Number of events 3
|
1.7%
5/293 • Number of events 5
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Injury, poisoning and procedural complications
Fall
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Injury, poisoning and procedural complications
Muscle Rupture
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Injury, poisoning and procedural complications
Postoperative Wound Complication
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Injury, poisoning and procedural complications
Stab Wound
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.34%
1/290 • Number of events 2
|
0.00%
0/293
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.34%
1/290 • Number of events 2
|
0.00%
0/293
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Injury, poisoning and procedural complications
Periprosthetic Fracture
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subcutaneous Haematoma
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.00%
0/290
|
1.0%
3/293 • Number of events 3
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Alanine Aminotransferase Increased
|
9.3%
27/290 • Number of events 32
|
4.8%
14/293 • Number of events 15
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.5%
16/290 • Number of events 18
|
5.1%
15/293 • Number of events 15
|
|
Investigations
Lymphocyte Count Decreased
|
2.4%
7/290 • Number of events 8
|
0.68%
2/293 • Number of events 3
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
1.7%
5/290 • Number of events 5
|
1.4%
4/293 • Number of events 4
|
|
Investigations
Neutrophil Count Increased
|
1.4%
4/290 • Number of events 5
|
0.00%
0/293
|
|
Investigations
Blood Creatinine Increased
|
1.0%
3/290 • Number of events 3
|
0.68%
2/293 • Number of events 2
|
|
Investigations
Blood Pressure Increased
|
1.0%
3/290 • Number of events 3
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.69%
2/290 • Number of events 2
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Blood Bilirubin Increased
|
0.69%
2/290 • Number of events 2
|
0.34%
1/293 • Number of events 2
|
|
Investigations
Haemoglobin Decreased
|
0.69%
2/290 • Number of events 2
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Neutrophil Count Decreased
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Investigations
Transaminases Increased
|
0.69%
2/290 • Number of events 3
|
0.00%
0/293
|
|
Investigations
White Blood Cell Count Decreased
|
0.69%
2/290 • Number of events 5
|
0.68%
2/293 • Number of events 4
|
|
Investigations
Aspiration Joint
|
0.34%
1/290 • Number of events 2
|
0.00%
0/293
|
|
Investigations
Blood Calcium Increased
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Investigations
Blood Glucose Increased
|
0.34%
1/290 • Number of events 1
|
1.4%
4/293 • Number of events 4
|
|
Investigations
Blood Phosphorus Decreased
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Investigations
C-Reactive Protein Increased
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Glucose Urine
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Granulocyte Count Decreased
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Investigations
International Normalised Ratio Decreased
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Investigations
International Normalised Ratio Increased
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Investigations
Lymphocyte Count Increased
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Investigations
Platelet Count Decreased
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Investigations
Vitamin B12 Decreased
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Investigations
White Blood Cell Count Increased
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Alanine Aminotransferase Abnormal
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Antinuclear Antibody Increased
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Investigations
Antinuclear Antibody Positive
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Investigations
Blood Cholesterol Increased
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Blood Potassium Increased
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Investigations
Body Temperature Increased
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Double Stranded Dna Antibody
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Investigations
Electrocardiogram Abnormal
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Haematocrit Decreased
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Haematology Test Abnormal
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Red Blood Cell Count Decreased
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Red Blood Cell Sedimentation Rate Increased
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Investigations
Weight Decreased
|
0.00%
0/290
|
0.68%
2/293 • Number of events 3
|
|
Metabolism and nutrition disorders
Obesity
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
8.3%
24/290 • Number of events 30
|
5.1%
15/293 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
8/290 • Number of events 9
|
3.1%
9/293 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.8%
8/290 • Number of events 8
|
4.8%
14/293 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
1.7%
5/290 • Number of events 6
|
0.00%
0/293
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.0%
3/290 • Number of events 5
|
1.0%
3/293 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
3/290 • Number of events 3
|
1.0%
3/293 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.69%
2/290 • Number of events 2
|
1.0%
3/293 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
|
0.34%
1/290 • Number of events 11
|
0.00%
0/293
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.34%
1/290 • Number of events 1
|
1.4%
4/293 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Lupus-Like Syndrome
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Musculoskeletal and connective tissue disorders
Muscle Contracture
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.34%
1/290 • Number of events 2
|
0.68%
2/293 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic Fracture
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Nodule
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/290
|
1.0%
3/293 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Ligament Disorder
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis Postmenopausal
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Lung Neoplasm
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye Naevus
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Submucosal Tumour
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma Of Liver
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Neoplasm
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm Of Thyroid Gland
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Salivary Gland Neoplasm
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip And/Or Oral Cavity Cancer
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Nervous system disorders
Headache
|
5.5%
16/290 • Number of events 30
|
5.1%
15/293 • Number of events 16
|
|
Nervous system disorders
Dizziness
|
1.0%
3/290 • Number of events 4
|
2.4%
7/293 • Number of events 11
|
|
Nervous system disorders
Cerebrovascular Insufficiency
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Nervous system disorders
Demyelination
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Nervous system disorders
Formication
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Nervous system disorders
Hypertensive Encephalopathy
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Nervous system disorders
Hypoaesthesia
|
0.34%
1/290 • Number of events 2
|
0.34%
1/293 • Number of events 1
|
|
Nervous system disorders
Intercostal Neuralgia
|
0.34%
1/290 • Number of events 2
|
0.00%
0/293
|
|
Nervous system disorders
Migraine
|
0.34%
1/290 • Number of events 4
|
0.34%
1/293 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.34%
1/290 • Number of events 1
|
1.0%
3/293 • Number of events 5
|
|
Nervous system disorders
Paraesthesia
|
0.34%
1/290 • Number of events 2
|
1.4%
4/293 • Number of events 4
|
|
Nervous system disorders
Sciatica
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Nervous system disorders
Sinus Headache
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Nervous system disorders
Somnolence
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Nervous system disorders
Syncope
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Nervous system disorders
Trigeminal Neuralgia
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Nervous system disorders
Aphasia
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Nervous system disorders
Burning Sensation
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Nervous system disorders
Cerebral Atrophy
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Nervous system disorders
Loss Of Consciousness
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Psychiatric disorders
Sleep Disorder
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Psychiatric disorders
Anxiety
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Psychiatric disorders
Anxiety Disorder
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Psychiatric disorders
Neurosis
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Renal and urinary disorders
Dysuria
|
0.34%
1/290 • Number of events 2
|
0.00%
0/293
|
|
Renal and urinary disorders
Renal Colic
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Reproductive system and breast disorders
Endometriosis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Reproductive system and breast disorders
Breast Cyst
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Reproductive system and breast disorders
Breast Mass
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Reproductive system and breast disorders
Menopausal Symptoms
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.00%
0/290
|
0.34%
1/293 • Number of events 2
|
|
Reproductive system and breast disorders
Ovarian Cyst Torsion
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal Inflammation
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
7/290 • Number of events 8
|
3.1%
9/293 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
1.0%
3/290 • Number of events 4
|
0.68%
2/293 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.69%
2/290 • Number of events 2
|
0.68%
2/293 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.69%
2/290 • Number of events 2
|
0.00%
0/293
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.34%
1/290 • Number of events 1
|
0.68%
2/293 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Septum Deviation
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Erythema
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Vocal Cord Thickening
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
7/290 • Number of events 8
|
2.4%
7/293 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.69%
2/290 • Number of events 2
|
0.68%
2/293 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic Eczema
|
0.69%
2/290 • Number of events 2
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.69%
2/290 • Number of events 2
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.69%
2/290 • Number of events 2
|
0.68%
2/293 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.34%
1/290 • Number of events 4
|
0.00%
0/293
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.34%
1/290 • Number of events 1
|
1.7%
5/293 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema Nodosum
|
0.34%
1/290 • Number of events 2
|
0.00%
0/293
|
|
Skin and subcutaneous tissue disorders
Pityriasis
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.34%
1/290 • Number of events 2
|
1.7%
5/293 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Pruritus Allergic
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pustular Psoriasis
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.34%
1/290 • Number of events 10
|
0.00%
0/293
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
0.34%
1/290 • Number of events 3
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Swelling
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.34%
1/290 • Number of events 1
|
1.0%
3/293 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative
|
0.00%
0/290
|
0.34%
1/293 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/290
|
1.0%
3/293 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Lichenoid Keratosis
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pigmentation Disorder
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pityriasis Rosea
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/290
|
0.68%
2/293 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Surgical and medical procedures
Tooth Extraction
|
0.00%
0/290
|
1.0%
3/293 • Number of events 3
|
|
Vascular disorders
Hypertension
|
2.8%
8/290 • Number of events 8
|
3.4%
10/293 • Number of events 11
|
|
Vascular disorders
Aortic Arteriosclerosis
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Vascular disorders
Blood Pressure Fluctuation
|
0.34%
1/290 • Number of events 1
|
0.00%
0/293
|
|
Vascular disorders
Flushing
|
0.34%
1/290 • Number of events 3
|
0.34%
1/293 • Number of events 1
|
|
Vascular disorders
Hot Flush
|
0.34%
1/290 • Number of events 1
|
0.34%
1/293 • Number of events 1
|
|
Vascular disorders
Hypertensive Crisis
|
0.34%
1/290 • Number of events 1
|
0.68%
2/293 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.00%
0/290
|
0.68%
2/293 • Number of events 2
|
|
Vascular disorders
Raynaud'S Phenomenon
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Vascular disorders
Varicose Vein
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
|
Vascular disorders
Venous Insufficiency
|
0.00%
0/290
|
0.34%
1/293 • Number of events 1
|
Additional Information
Director, Clinical Development
Samsung Bioepis
Phone: +82 31 8061 4534
Results disclosure agreements
- Principal investigator is a sponsor employee At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them. If the Sponsor requests, the Site shall remove any Confidential Information (other than Study results) prior to submitting or presenting the materials.
- Publication restrictions are in place
Restriction type: OTHER