Trial Outcomes & Findings for A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (NCT NCT01895309)
NCT ID: NCT01895309
Last Updated: 2017-08-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
596 participants
Primary outcome timeframe
Week 24
Results posted on
2017-08-17
Participant Flow
Participant milestones
| Measure |
SB4 (Proposed Biosimilar to Etanercept)
SB4 50 mg/week via subcutaneous injection
|
Enbrel (Etanercept)
Enbrel 50 mg/week via subcutaneous injection
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
40
|
51
|
|
Overall Study
STARTED
|
299
|
297
|
|
Overall Study
COMPLETED
|
259
|
246
|
Reasons for withdrawal
| Measure |
SB4 (Proposed Biosimilar to Etanercept)
SB4 50 mg/week via subcutaneous injection
|
Enbrel (Etanercept)
Enbrel 50 mg/week via subcutaneous injection
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
17
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Physician Decision
|
15
|
10
|
|
Overall Study
Withdrawal by Subject
|
9
|
18
|
Baseline Characteristics
A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Baseline characteristics by cohort
| Measure |
SB4 (Proposed Biosimilar to Etanercept)
n=299 Participants
SB4 50 mg/week via subcutaneous injection
|
Enbrel (Etanercept)
n=297 Participants
Enbrel 50 mg/week via subcutaneous injection
|
Total
n=596 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 11.72 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 11.63 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 11.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
249 Participants
n=5 Participants
|
253 Participants
n=7 Participants
|
502 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Outcome measures
| Measure |
SB4 (Proposed Biosimilar to Etanercept)
n=247 Participants
SB4 50 mg/week via subcutaneous injection
|
Enbrel (Etanercept)
n=236 Participants
Enbrel 50 mg/week via subcutaneous injection
|
SB4 (Proposed Biosimilar to Etanercept) at Week 52
SB4 50 mg/week via subcutaneous injection
SB4 (proposed biosimilar to etanercept)
|
Enbrel (Etanercept) at Week 52
Enbrel 50 mg/week via subcutaneous injection
Enbrel (etanercept)
|
|---|---|---|---|---|
|
American College of Rheumatology 20% Response Criteria (ACR20)
|
78.1 percentage of participants
|
80.5 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Outcome measures
| Measure |
SB4 (Proposed Biosimilar to Etanercept)
n=224 Participants
SB4 50 mg/week via subcutaneous injection
|
Enbrel (Etanercept)
n=216 Participants
Enbrel 50 mg/week via subcutaneous injection
|
SB4 (Proposed Biosimilar to Etanercept) at Week 52
SB4 50 mg/week via subcutaneous injection
SB4 (proposed biosimilar to etanercept)
|
Enbrel (Etanercept) at Week 52
Enbrel 50 mg/week via subcutaneous injection
Enbrel (etanercept)
|
|---|---|---|---|---|
|
ACR20
|
80.8 percentage of participants
|
81.5 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24, Week 52Outcome measures
| Measure |
SB4 (Proposed Biosimilar to Etanercept)
n=247 Participants
SB4 50 mg/week via subcutaneous injection
|
Enbrel (Etanercept)
n=236 Participants
Enbrel 50 mg/week via subcutaneous injection
|
SB4 (Proposed Biosimilar to Etanercept) at Week 52
n=224 Participants
SB4 50 mg/week via subcutaneous injection
SB4 (proposed biosimilar to etanercept)
|
Enbrel (Etanercept) at Week 52
n=216 Participants
Enbrel 50 mg/week via subcutaneous injection
Enbrel (etanercept)
|
|---|---|---|---|---|
|
American College of Rheumatology 50% Response Criteria (ACR50)
|
46.2 percentage of participants
|
42.4 percentage of participants
|
58.5 percentage of participants
|
53.2 percentage of participants
|
Adverse Events
SB4 (Proposed Biosimilar to Etanercept)
Serious events: 18 serious events
Other events: 175 other events
Deaths: 0 deaths
Enbrel (Etanercept)
Serious events: 15 serious events
Other events: 179 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB4 (Proposed Biosimilar to Etanercept)
n=299 participants at risk
SB4 50 mg/week via subcutaneous injection
SB4 (proposed biosimilar to etanercept)
|
Enbrel (Etanercept)
n=297 participants at risk
Enbrel 50 mg/week via subcutaneous injection
Enbrel (etanercept)
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Cardiac disorders
Atrial Fibrillation
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
General disorders
Device Failure
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.33%
1/299 • Number of events 2
|
0.00%
0/297
|
|
Hepatobiliary disorders
Cholangitis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Hepatobiliary disorders
Cholecystitis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Hepatobiliary disorders
Gallbladder Perforation
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Liver Abscess
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Peritonitis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Appendicitis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/299
|
0.67%
2/297 • Number of events 2
|
|
Infections and infestations
Erysipelas
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.33%
1/299 • Number of events 1
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Still'S Disease Adult Onset
|
0.33%
1/299 • Number of events 2
|
0.00%
0/297
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Gastric
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Reproductive system and breast disorders
Vaginal Prolapse
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
Other adverse events
| Measure |
SB4 (Proposed Biosimilar to Etanercept)
n=299 participants at risk
SB4 50 mg/week via subcutaneous injection
SB4 (proposed biosimilar to etanercept)
|
Enbrel (Etanercept)
n=297 participants at risk
Enbrel 50 mg/week via subcutaneous injection
Enbrel (etanercept)
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
2.0%
6/299 • Number of events 7
|
1.0%
3/297 • Number of events 4
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
5/299 • Number of events 5
|
1.0%
3/297 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
4/299 • Number of events 4
|
1.7%
5/297 • Number of events 7
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.0%
3/299 • Number of events 3
|
0.00%
0/297
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.67%
2/299 • Number of events 2
|
1.3%
4/297 • Number of events 4
|
|
Blood and lymphatic system disorders
Anaemia Of Chronic Disease
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/299
|
1.0%
3/297 • Number of events 4
|
|
Cardiac disorders
Tachycardia
|
0.67%
2/299 • Number of events 2
|
0.34%
1/297 • Number of events 1
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Cardiac disorders
Atrial Fibrillation
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Cardiac disorders
Cardiovascular Insufficiency
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Cardiac disorders
Mitral Valve Prolapse
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/299
|
0.67%
2/297 • Number of events 2
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
3/299 • Number of events 3
|
0.34%
1/297 • Number of events 1
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Ear and labyrinth disorders
External Ear Inflammation
|
0.00%
0/299
|
0.67%
2/297 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Endocrine disorders
Goitre
|
0.33%
1/299 • Number of events 1
|
0.34%
1/297 • Number of events 1
|
|
Endocrine disorders
Thyroid Cyst
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Eye disorders
Eyelid Oedema
|
0.67%
2/299 • Number of events 3
|
0.00%
0/297
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.33%
1/299 • Number of events 1
|
0.34%
1/297 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Eye disorders
Dry Eye
|
0.33%
1/299 • Number of events 1
|
0.34%
1/297 • Number of events 1
|
|
Eye disorders
Eye Irritation
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Eye disorders
Eyelid Ptosis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Eye disorders
Vision Blurred
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Eye disorders
Cataract
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Eye disorders
Presbyopia
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
5/299 • Number of events 5
|
2.4%
7/297 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.3%
4/299 • Number of events 5
|
1.3%
4/297 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
1.3%
4/299 • Number of events 8
|
0.34%
1/297 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.67%
2/299 • Number of events 2
|
1.0%
3/297 • Number of events 4
|
|
Gastrointestinal disorders
Dyspepsia
|
0.67%
2/299 • Number of events 2
|
1.3%
4/297 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Gastrointestinal disorders
Constipation
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.33%
1/299 • Number of events 1
|
0.34%
1/297 • Number of events 1
|
|
Gastrointestinal disorders
Enterocele
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.33%
1/299 • Number of events 1
|
0.67%
2/297 • Number of events 2
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Gastrointestinal disorders
Parotid Gland Inflammation
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/299
|
0.67%
2/297 • Number of events 2
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/299
|
1.3%
4/297 • Number of events 5
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/299
|
0.67%
2/297 • Number of events 2
|
|
Gastrointestinal disorders
Portal Hypertensive Gastropathy
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Gastrointestinal disorders
Reflux Gastritis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/299
|
1.0%
3/297 • Number of events 3
|
|
General disorders
Injection Site Erythema
|
2.0%
6/299 • Number of events 16
|
11.1%
33/297 • Number of events 85
|
|
General disorders
Influenza Like Illness
|
1.0%
3/299 • Number of events 5
|
0.34%
1/297 • Number of events 1
|
|
General disorders
Oedema Peripheral
|
1.0%
3/299 • Number of events 3
|
1.0%
3/297 • Number of events 4
|
|
General disorders
Asthenia
|
0.67%
2/299 • Number of events 2
|
1.7%
5/297 • Number of events 5
|
|
General disorders
Chest Pain
|
0.67%
2/299 • Number of events 3
|
0.67%
2/297 • Number of events 3
|
|
General disorders
Chills
|
0.67%
2/299 • Number of events 2
|
0.00%
0/297
|
|
General disorders
Fatigue
|
0.67%
2/299 • Number of events 2
|
1.3%
4/297 • Number of events 4
|
|
General disorders
Injection Site Rash
|
0.67%
2/299 • Number of events 2
|
2.0%
6/297 • Number of events 11
|
|
General disorders
Pain
|
0.67%
2/299 • Number of events 2
|
0.34%
1/297 • Number of events 1
|
|
General disorders
Spinal Pain
|
0.67%
2/299 • Number of events 3
|
0.34%
1/297 • Number of events 1
|
|
General disorders
Device Failure
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
General disorders
Injection Site Haematoma
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
General disorders
Injection Site Hypersensitivity
|
0.33%
1/299 • Number of events 1
|
0.67%
2/297 • Number of events 10
|
|
General disorders
Injection Site Pruritus
|
0.33%
1/299 • Number of events 1
|
1.3%
4/297 • Number of events 6
|
|
General disorders
Injection Site Reaction
|
0.33%
1/299 • Number of events 1
|
2.7%
8/297 • Number of events 13
|
|
General disorders
Pyrexia
|
0.33%
1/299 • Number of events 1
|
0.67%
2/297 • Number of events 3
|
|
General disorders
Application Site Erythema
|
0.00%
0/299
|
1.0%
3/297 • Number of events 18
|
|
General disorders
Application Site Reaction
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
General disorders
Face Oedema
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
General disorders
Feeling Hot
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
General disorders
Injection Site Bruising
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
General disorders
Injection Site Dermatitis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 2
|
|
General disorders
Injection Site Inflammation
|
0.00%
0/299
|
0.67%
2/297 • Number of events 2
|
|
General disorders
Injection Site Oedema
|
0.00%
0/299
|
1.0%
3/297 • Number of events 6
|
|
General disorders
Injection Site Pain
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
General disorders
Injection Site Swelling
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
General disorders
Malaise
|
0.00%
0/299
|
0.67%
2/297 • Number of events 3
|
|
General disorders
Soft Tissue Inflammation
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.3%
4/299 • Number of events 4
|
0.00%
0/297
|
|
Hepatobiliary disorders
Liver Disorder
|
1.0%
3/299 • Number of events 3
|
0.00%
0/297
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.67%
2/299 • Number of events 3
|
0.00%
0/297
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.33%
1/299 • Number of events 2
|
0.00%
0/297
|
|
Hepatobiliary disorders
Biliary Colic
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Hepatobiliary disorders
Cholangitis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Hepatobiliary disorders
Cholecystitis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Hepatobiliary disorders
Gallbladder Perforation
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Immune system disorders
Allergy To Arthropod Bite
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.0%
24/299 • Number of events 28
|
5.4%
16/297 • Number of events 18
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
15/299 • Number of events 17
|
5.4%
16/297 • Number of events 17
|
|
Infections and infestations
Viral Infection
|
2.3%
7/299 • Number of events 7
|
1.7%
5/297 • Number of events 5
|
|
Infections and infestations
Bronchitis
|
2.0%
6/299 • Number of events 6
|
2.0%
6/297 • Number of events 6
|
|
Infections and infestations
Rhinitis
|
2.0%
6/299 • Number of events 6
|
1.3%
4/297 • Number of events 5
|
|
Infections and infestations
Pharyngitis
|
1.7%
5/299 • Number of events 5
|
2.7%
8/297 • Number of events 9
|
|
Infections and infestations
Urinary Tract Infection
|
1.7%
5/299 • Number of events 5
|
2.4%
7/297 • Number of events 9
|
|
Infections and infestations
Oral Herpes
|
1.3%
4/299 • Number of events 7
|
1.7%
5/297 • Number of events 6
|
|
Infections and infestations
Herpes Zoster
|
1.0%
3/299 • Number of events 5
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Asymptomatic Bacteriuria
|
0.67%
2/299 • Number of events 3
|
0.00%
0/297
|
|
Infections and infestations
Ear Infection
|
0.67%
2/299 • Number of events 2
|
0.00%
0/297
|
|
Infections and infestations
Otitis Externa
|
0.67%
2/299 • Number of events 2
|
0.00%
0/297
|
|
Infections and infestations
Pharyngotonsillitis
|
0.67%
2/299 • Number of events 2
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.67%
2/299 • Number of events 2
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.67%
2/299 • Number of events 2
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.67%
2/299 • Number of events 2
|
1.0%
3/297 • Number of events 3
|
|
Infections and infestations
Acute Tonsillitis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Bacteriuria
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Cellulitis
|
0.33%
1/299 • Number of events 1
|
0.67%
2/297 • Number of events 2
|
|
Infections and infestations
Chronic Tonsillitis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Diverticulitis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Erysipelas
|
0.33%
1/299 • Number of events 1
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Fungal Infection
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Furuncle
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Gastroenteritis
|
0.33%
1/299 • Number of events 1
|
0.67%
2/297 • Number of events 2
|
|
Infections and infestations
Herpes Simplex
|
0.33%
1/299 • Number of events 1
|
0.67%
2/297 • Number of events 2
|
|
Infections and infestations
Liver Abscess
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Localised Infection
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Lyme Disease
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Otitis Media
|
0.33%
1/299 • Number of events 1
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Peritonitis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Pharyngitis Bacterial
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Pyelonephritis
|
0.33%
1/299 • Number of events 1
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Rash Pustular
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Respiratory Tract Infection
|
0.33%
1/299 • Number of events 1
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Tinea Pedis
|
0.33%
1/299 • Number of events 1
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Tinea Versicolour
|
0.33%
1/299 • Number of events 1
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Tonsillitis
|
0.33%
1/299 • Number of events 1
|
0.67%
2/297 • Number of events 2
|
|
Infections and infestations
Tooth Infection
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Tracheobronchitis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Eczema Infected
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Gingivitis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 2
|
|
Infections and infestations
Herpes Virus Infection
|
0.00%
0/299
|
0.34%
1/297 • Number of events 2
|
|
Infections and infestations
Influenza
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Laryngitis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Nail Candida
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Periodontitis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Peritonitis Bacterial
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Pulpitis Dental
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Infections and infestations
Viral Rhinitis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 2
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.67%
2/299 • Number of events 3
|
0.34%
1/297 • Number of events 1
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.67%
2/299 • Number of events 2
|
0.00%
0/297
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.33%
1/299 • Number of events 1
|
0.34%
1/297 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Injury, poisoning and procedural complications
Traumatic Fracture
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injection Related Reaction
|
0.00%
0/299
|
0.34%
1/297 • Number of events 2
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/299
|
0.34%
1/297 • Number of events 2
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/299
|
0.34%
1/297 • Number of events 2
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/299
|
0.67%
2/297 • Number of events 2
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Investigations
Alanine Aminotransferase Increased
|
6.0%
18/299 • Number of events 25
|
5.7%
17/297 • Number of events 26
|
|
Investigations
Aspartate Aminotransferase Increased
|
2.7%
8/299 • Number of events 13
|
3.0%
9/297 • Number of events 10
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
1.7%
5/299 • Number of events 11
|
1.7%
5/297 • Number of events 6
|
|
Investigations
Lymphocyte Count Decreased
|
1.3%
4/299 • Number of events 4
|
2.0%
6/297 • Number of events 8
|
|
Investigations
Transaminases Increased
|
1.3%
4/299 • Number of events 5
|
1.3%
4/297 • Number of events 4
|
|
Investigations
Blood Pressure Increased
|
1.0%
3/299 • Number of events 4
|
1.0%
3/297 • Number of events 3
|
|
Investigations
Liver Function Test Abnormal
|
1.0%
3/299 • Number of events 4
|
0.67%
2/297 • Number of events 2
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.67%
2/299 • Number of events 4
|
0.00%
0/297
|
|
Investigations
Blood Glucose Increased
|
0.67%
2/299 • Number of events 2
|
0.00%
0/297
|
|
Investigations
Hepatic Enzyme Increased
|
0.67%
2/299 • Number of events 4
|
0.00%
0/297
|
|
Investigations
Neutrophil Count Decreased
|
0.67%
2/299 • Number of events 2
|
0.34%
1/297 • Number of events 1
|
|
Investigations
White Blood Cell Count Decreased
|
0.67%
2/299 • Number of events 2
|
0.34%
1/297 • Number of events 1
|
|
Investigations
Blood Urine Present
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Investigations
Haemoglobin Decreased
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Investigations
Neutrophil Count Increased
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Investigations
Nitrite Urine Present
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Investigations
Urine Analysis Abnormal
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Investigations
Weight Increased
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Investigations
Blood Calcium Decreased
|
0.00%
0/299
|
0.34%
1/297 • Number of events 2
|
|
Investigations
Blood Phosphorus Decreased
|
0.00%
0/299
|
0.67%
2/297 • Number of events 3
|
|
Investigations
Lymphocyte Count Abnormal
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Investigations
Lymphocyte Count Increased
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/299
|
0.34%
1/297 • Number of events 3
|
|
Investigations
Platelet Count Increased
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/299
|
0.67%
2/297 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic Syndrome
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
3.0%
9/299 • Number of events 10
|
3.4%
10/297 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
4/299 • Number of events 5
|
1.7%
5/297 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.3%
4/299 • Number of events 5
|
1.3%
4/297 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.67%
2/299 • Number of events 2
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.67%
2/299 • Number of events 2
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.67%
2/299 • Number of events 2
|
0.67%
2/297 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.67%
2/299 • Number of events 2
|
0.00%
0/297
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Musculoskeletal and connective tissue disorders
Fracture Delayed Union
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.33%
1/299 • Number of events 2
|
0.00%
0/297
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.33%
1/299 • Number of events 1
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.33%
1/299 • Number of events 1
|
0.67%
2/297 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Sjogren'S Syndrome
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Musculoskeletal and connective tissue disorders
Still'S Disease Adult Onset
|
0.33%
1/299 • Number of events 2
|
0.00%
0/297
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Enthesopathy
|
0.00%
0/299
|
0.34%
1/297 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Nuchal Rigidity
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/299
|
0.67%
2/297 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic Fracture
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal Deformity
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.67%
2/299 • Number of events 2
|
0.34%
1/297 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Gastric
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma Of Liver
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic Naevus
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Fibroma
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic Granuloma
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Nervous system disorders
Headache
|
4.3%
13/299 • Number of events 15
|
2.7%
8/297 • Number of events 16
|
|
Nervous system disorders
Dizziness
|
0.67%
2/299 • Number of events 3
|
2.4%
7/297 • Number of events 7
|
|
Nervous system disorders
Syncope
|
0.67%
2/299 • Number of events 2
|
0.34%
1/297 • Number of events 1
|
|
Nervous system disorders
Anosmia
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Nervous system disorders
Disturbance In Attention
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Nervous system disorders
Dystonia
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Nervous system disorders
Hypoaesthesia
|
0.33%
1/299 • Number of events 2
|
0.34%
1/297 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Nervous system disorders
Parosmia
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Nervous system disorders
Radiculopathy
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Nervous system disorders
Sciatica
|
0.33%
1/299 • Number of events 1
|
0.67%
2/297 • Number of events 3
|
|
Nervous system disorders
Stupor
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Nervous system disorders
Aphasia
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Nervous system disorders
Hypertensive Encephalopathy
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Nervous system disorders
Loss Of Consciousness
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/299
|
0.67%
2/297 • Number of events 2
|
|
Nervous system disorders
Tremor
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.67%
2/299 • Number of events 2
|
0.34%
1/297 • Number of events 1
|
|
Psychiatric disorders
Sleep Disorder
|
0.67%
2/299 • Number of events 2
|
0.00%
0/297
|
|
Psychiatric disorders
Anxiety
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Psychiatric disorders
Anxiety Disorder
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Psychiatric disorders
Initial Insomnia
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Psychiatric disorders
Tachyphrenia
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Psychiatric disorders
Neurosis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.67%
2/299 • Number of events 3
|
0.67%
2/297 • Number of events 3
|
|
Renal and urinary disorders
Calculus Bladder
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Renal and urinary disorders
Renal Cyst
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Renal and urinary disorders
Urinary Tract Inflammation
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Reproductive system and breast disorders
Breast Mass
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Reproductive system and breast disorders
Breast Pain
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Reproductive system and breast disorders
Breast Swelling
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Reproductive system and breast disorders
Cervical Polyp
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Reproductive system and breast disorders
Vaginal Prolapse
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Reproductive system and breast disorders
Vulvovaginal Pruritus
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Reproductive system and breast disorders
Breast Induration
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Reproductive system and breast disorders
Menopausal Symptoms
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
4/299 • Number of events 4
|
3.4%
10/297 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.3%
4/299 • Number of events 5
|
0.34%
1/297 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
0.67%
2/299 • Number of events 2
|
0.34%
1/297 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar Hypertrophy
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/299
|
0.67%
2/297 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Inflammation
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Atrophic
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
6/299 • Number of events 6
|
1.3%
4/297 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
1.0%
3/299 • Number of events 3
|
0.34%
1/297 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
1.0%
3/299 • Number of events 4
|
0.34%
1/297 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.67%
2/299 • Number of events 2
|
1.0%
3/297 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.67%
2/299 • Number of events 4
|
3.4%
10/297 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.67%
2/299 • Number of events 2
|
1.0%
3/297 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.67%
2/299 • Number of events 2
|
1.3%
4/297 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.67%
2/299 • Number of events 2
|
0.00%
0/297
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Skin and subcutaneous tissue disorders
Erythema Annulare
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.33%
1/299 • Number of events 1
|
0.34%
1/297 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.33%
1/299 • Number of events 2
|
0.00%
0/297
|
|
Skin and subcutaneous tissue disorders
Skin Mass
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Umbilical Erythema
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Social circumstances
Menopause
|
0.00%
0/299
|
0.34%
1/297 • Number of events 1
|
|
Surgical and medical procedures
Tooth Extraction
|
0.00%
0/299
|
0.67%
2/297 • Number of events 2
|
|
Vascular disorders
Hypertension
|
3.7%
11/299 • Number of events 16
|
3.7%
11/297 • Number of events 12
|
|
Vascular disorders
Hypotension
|
0.67%
2/299 • Number of events 2
|
0.00%
0/297
|
|
Vascular disorders
Hypertensive Crisis
|
0.33%
1/299 • Number of events 1
|
0.34%
1/297 • Number of events 1
|
|
Vascular disorders
Vasculitis
|
0.33%
1/299 • Number of events 1
|
0.00%
0/297
|
|
Vascular disorders
Pallor
|
0.00%
0/299
|
0.34%
1/297 • 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