Trial Outcomes & Findings for A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis (NCT NCT00535782)
NCT ID: NCT00535782
Last Updated: 2017-07-26
Results Overview
Small LDL particles are associated with an increased risk of cardiovascular disease: more of these small particles lead to a greater risk. The concentration of fasting small LDL particles was determined using the Nuclear Magnetic Resonance (NMR) methodology.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
132 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2017-07-26
Participant Flow
Participant milestones
| Measure |
Part 1: TCZ + MTX
During Part 1 of the study participants in this group received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
|
Part 1: Placebo + MTX
During Part 1 of the study participants in this group received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
|
Part 2: TCZ + MTX
During Part 2 of the study, from Week 24 to Week 104, all participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly.
|
|---|---|---|---|
|
Part 1: 24-Week Double-blind Period
STARTED
|
69
|
63
|
0
|
|
Part 1: 24-Week Double-blind Period
Treated With TCZ + MTX
|
69
|
2
|
0
|
|
Part 1: 24-Week Double-blind Period
Treated With Placebo + MTX
|
0
|
62
|
0
|
|
Part 1: 24-Week Double-blind Period
COMPLETED
|
65
|
59
|
0
|
|
Part 1: 24-Week Double-blind Period
NOT COMPLETED
|
4
|
4
|
0
|
|
Part 2: 80-Week Open-label Period
STARTED
|
0
|
0
|
124
|
|
Part 2: 80-Week Open-label Period
COMPLETED
|
0
|
0
|
98
|
|
Part 2: 80-Week Open-label Period
NOT COMPLETED
|
0
|
0
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
TCZ + MTX
n=69 Participants
During Part 1 of the study participants received 8 mg/kg tocilizumab (TCZ) by intravenous (IV) infusion every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks. During Part 2, from Week 24 to Week 104, participants received open-label 8 mg/kg TCZ every 4 weeks plus 7.5-25 mg MTX weekly.
|
Placebo + MTX
n=63 Participants
During Part 1 of the study participants received placebo intravenous (IV) infusion every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks. During Part 2, from Week 24 to Week 104, participants received 8 mg/kg TCZ IV every 4 weeks plus 7.5-25 mg MTX weekly.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<52 years
|
23 participants
n=99 Participants
|
20 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Age, Customized
≥52 years
|
46 participants
n=99 Participants
|
43 participants
n=107 Participants
|
89 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
63 participants
n=99 Participants
|
55 participants
n=107 Participants
|
118 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=99 Participants
|
46 participants
n=107 Participants
|
87 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
23 participants
n=99 Participants
|
16 participants
n=107 Participants
|
39 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
6 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.
Small LDL particles are associated with an increased risk of cardiovascular disease: more of these small particles lead to a greater risk. The concentration of fasting small LDL particles was determined using the Nuclear Magnetic Resonance (NMR) methodology.
Outcome measures
| Measure |
TCZ + MTX
n=69 Participants
Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
|
Placebo + MTX
n=63 Participants
Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
|
|---|---|---|
|
Change From Baseline in Small Low Density Lipoprotein (sLDL) Particle Numbers
Baseline (n=63, 59)
|
737.79 nmol/L
Standard Deviation 467.097
|
792.78 nmol/L
Standard Deviation 392.051
|
|
Change From Baseline in Small Low Density Lipoprotein (sLDL) Particle Numbers
Week 12 (n=69, 63)
|
768.04 nmol/L
Standard Deviation 628.281
|
777.71 nmol/L
Standard Deviation 394.527
|
|
Change From Baseline in Small Low Density Lipoprotein (sLDL) Particle Numbers
Change from Baseline at Week 12 (n=63, 59)
|
23.73 nmol/L
Standard Deviation 368.273
|
22.41 nmol/L
Standard Deviation 237.476
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.
Aortic (central) arterial stiffness was assessed with Pulse Wave Analysis (PWA) of the radial artery and carotid-femoral PWV using applanation tonometry after the patient had rested in a supine position for at least 10 minutes.
Outcome measures
| Measure |
TCZ + MTX
n=69 Participants
Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
|
Placebo + MTX
n=63 Participants
Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
|
|---|---|---|
|
Change From Baseline to Week 12 in Aortic Pulse Wave Velocity (PWV)
Baseline (n=69, 59)
|
8.97 meters/second
Standard Deviation 1.970
|
9.01 meters/second
Standard Deviation 2.519
|
|
Change From Baseline to Week 12 in Aortic Pulse Wave Velocity (PWV)
Week 12 (n=69, 62)
|
8.94 meters/second
Standard Deviation 2.510
|
8.39 meters/second
Standard Deviation 1.836
|
|
Change From Baseline to Week 12 in Aortic Pulse Wave Velocity (PWV)
Change from Baseline at Week 12 (n=69, 59)
|
-0.03 meters/second
Standard Deviation 1.970
|
-0.68 meters/second
Standard Deviation 1.741
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.
Small LDL particles are associated with an increased risk of cardiovascular disease: more of these small particles lead to a greater risk. The concentration of fasting small LDL particles was determined using the Nuclear Magnetic Resonance (NMR) methodology.
Outcome measures
| Measure |
TCZ + MTX
n=69 Participants
Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
|
Placebo + MTX
n=63 Participants
Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in Small Low Density Lipoprotein (sLDL) Particle Numbers
Change from Baseline at Week 24 (n=63, 59)
|
39.03 nmol/L
Standard Deviation 367.786
|
32.41 nmol/L
Standard Deviation 250.576
|
|
Change From Baseline to Week 24 in Small Low Density Lipoprotein (sLDL) Particle Numbers
Baseline (n=63, 59)
|
737.79 nmol/L
Standard Deviation 467.097
|
792.78 nmol/L
Standard Deviation 392.051
|
|
Change From Baseline to Week 24 in Small Low Density Lipoprotein (sLDL) Particle Numbers
Week 24 (n=69, 63)
|
792.78 nmol/L
Standard Deviation 605.485
|
801.78 nmol/L
Standard Deviation 398.910
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.
Aortic (central) arterial stiffness was assessed with Pulse Wave Analysis (PWA) of the radial artery and carotid-femoral PWV using applanation tonometry after the patient had rested in a supine position for at least 10 minutes.
Outcome measures
| Measure |
TCZ + MTX
n=69 Participants
Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
|
Placebo + MTX
n=63 Participants
Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in Aortic Pulse Wave Velocity (PWV)
Baseline (n=69, 59)
|
8.97 meters/second
Standard Deviation 1.970
|
9.01 meters/second
Standard Deviation 2.519
|
|
Change From Baseline to Week 24 in Aortic Pulse Wave Velocity (PWV)
Week 24 (n=69, 62)
|
8.98 meters/second
Standard Deviation 2.337
|
8.85 meters/second
Standard Deviation 2.014
|
|
Change From Baseline to Week 24 in Aortic Pulse Wave Velocity (PWV)
Change from Baseline at Week 24 (n=69, 59)
|
0.01 meters/second
Standard Deviation 1.946
|
-0.20 meters/second
Standard Deviation 1.792
|
SECONDARY outcome
Timeframe: Up to Week 24Population: The safety population includes all patients who received any part of an infusion of study drug and who provided at least one assessment of safety. Randomized patients who received the incorrect therapy from that intended are summarized in the group according to the therapy actually received.
A severe AE is an event in which the intensity of the event results in an inability to work or perform normal daily activity. A Serious AE is fatal, life-threatening, requires in-patient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant or requires intervention to prevent one of the above outcomes. AEs of special interest include infection, gastrointestinal, infusion reaction (occurring during or within 24 hours of infusion), hepatic disorder, myocardial infarction and stroke.
Outcome measures
| Measure |
TCZ + MTX
n=70 Participants
Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
|
Placebo + MTX
n=62 Participants
Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
|
|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
Hepatic disorder AEs
|
0 participants
|
0 participants
|
|
Number of Participants Experiencing Adverse Events (AEs)
Myocardial infarction
|
0 participants
|
0 participants
|
|
Number of Participants Experiencing Adverse Events (AEs)
Stroke
|
0 participants
|
0 participants
|
|
Number of Participants Experiencing Adverse Events (AEs)
Any AE
|
59 participants
|
45 participants
|
|
Number of Participants Experiencing Adverse Events (AEs)
Severe AE
|
7 participants
|
4 participants
|
|
Number of Participants Experiencing Adverse Events (AEs)
Serious AE
|
3 participants
|
2 participants
|
|
Number of Participants Experiencing Adverse Events (AEs)
Deaths
|
0 participants
|
0 participants
|
|
Number of Participants Experiencing Adverse Events (AEs)
Withdrawals due to AE
|
2 participants
|
1 participants
|
|
Number of Participants Experiencing Adverse Events (AEs)
Pregnancy
|
0 participants
|
0 participants
|
|
Number of Participants Experiencing Adverse Events (AEs)
Infection AEs
|
42 participants
|
17 participants
|
|
Number of Participants Experiencing Adverse Events (AEs)
Gastrointestinal AEs
|
22 participants
|
10 participants
|
|
Number of Participants Experiencing Adverse Events (AEs)
Infusion reaction AEs
|
12 participants
|
7 participants
|
Adverse Events
Part 1: TCZ + MTX
Serious events: 3 serious events
Other events: 59 other events
Deaths: 0 deaths
Part 1: Placebo + MTX
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
All TCZ + MTX
Serious events: 30 serious events
Other events: 124 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: TCZ + MTX
n=70 participants at risk
During Part 1 of the study participants in this group received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
|
Part 1: Placebo + MTX
n=62 participants at risk
During Part 1 of the study participants in this group received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
|
All TCZ + MTX
n=130 participants at risk
Includes patients who received at least one dose of active tocilizumab (TCZ) regardless of when they received it during the study and whether it was double-blind (Part 1) or open-label (Part 2). Participants received 8 mg/kg TCZ by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/70
|
1.6%
1/62
|
0.00%
0/130
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Bronchitis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Device related infection
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Pneumonia
|
0.00%
0/70
|
1.6%
1/62
|
0.77%
1/130
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Puncture site abscess
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/70
|
0.00%
0/62
|
3.1%
4/130
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
General disorders
Non-cardiac chest pain
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
General disorders
Chest pain
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Hepatobiliary disorders
Hepatic artery aneurysm
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Endocrine disorders
Goitre
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Renal and urinary disorders
Urinary incontinence
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
Other adverse events
| Measure |
Part 1: TCZ + MTX
n=70 participants at risk
During Part 1 of the study participants in this group received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
|
Part 1: Placebo + MTX
n=62 participants at risk
During Part 1 of the study participants in this group received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
|
All TCZ + MTX
n=130 participants at risk
Includes patients who received at least one dose of active tocilizumab (TCZ) regardless of when they received it during the study and whether it was double-blind (Part 1) or open-label (Part 2). Participants received 8 mg/kg TCZ by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
11.4%
8/70
|
9.7%
6/62
|
30.0%
39/130
|
|
Infections and infestations
Urinary tract infection
|
10.0%
7/70
|
3.2%
2/62
|
19.2%
25/130
|
|
Infections and infestations
Bronchitis
|
4.3%
3/70
|
3.2%
2/62
|
17.7%
23/130
|
|
Infections and infestations
Sinusitis
|
5.7%
4/70
|
1.6%
1/62
|
14.6%
19/130
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
5/70
|
0.00%
0/62
|
12.3%
16/130
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/70
|
3.2%
2/62
|
6.9%
9/130
|
|
Infections and infestations
Pneumonia
|
0.00%
0/70
|
0.00%
0/62
|
5.4%
7/130
|
|
Infections and infestations
Cellulitis
|
1.4%
1/70
|
0.00%
0/62
|
4.6%
6/130
|
|
Infections and infestations
Gastroenteritis viral
|
1.4%
1/70
|
0.00%
0/62
|
4.6%
6/130
|
|
Infections and infestations
Lower respiratory tract infection
|
2.9%
2/70
|
0.00%
0/62
|
4.6%
6/130
|
|
Infections and infestations
Oral herpes
|
1.4%
1/70
|
0.00%
0/62
|
4.6%
6/130
|
|
Infections and infestations
Otitis media
|
0.00%
0/70
|
0.00%
0/62
|
3.8%
5/130
|
|
Infections and infestations
Influenza
|
1.4%
1/70
|
3.2%
2/62
|
3.1%
4/130
|
|
Infections and infestations
Cystitis
|
2.9%
2/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Infections and infestations
Eye infection
|
0.00%
0/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Infections and infestations
Laryngitis
|
0.00%
0/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Infections and infestations
Localised infection
|
1.4%
1/70
|
1.6%
1/62
|
2.3%
3/130
|
|
Infections and infestations
Paronychia
|
1.4%
1/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Infections and infestations
Ear infection
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Infections and infestations
Folliculitis
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Infections and infestations
Furuncle
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Infections and infestations
Infected bites
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Infections and infestations
Labyrinthitis
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/70
|
1.6%
1/62
|
1.5%
2/130
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/70
|
1.6%
1/62
|
1.5%
2/130
|
|
Infections and infestations
Viral infection
|
0.00%
0/70
|
1.6%
1/62
|
1.5%
2/130
|
|
Infections and infestations
Alveolar osteitis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Blister infected
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Burn infection
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Fungal infection
|
0.00%
0/70
|
1.6%
1/62
|
0.77%
1/130
|
|
Infections and infestations
Fungal skin infection
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Gingival infection
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Hordeolum
|
1.4%
1/70
|
1.6%
1/62
|
0.77%
1/130
|
|
Infections and infestations
Impetigo
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Infected cyst
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Kidney infection
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Nail infection
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Osteomyelitis
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Papilloma viral infection
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Pharyngitis
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Rhinitis
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Sinobronchitis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Tinea cruris
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Tooth infection
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Wound infection
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Infections and infestations
Genital herpes
|
1.4%
1/70
|
0.00%
0/62
|
0.00%
0/130
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
5.7%
4/70
|
9.7%
6/62
|
12.3%
16/130
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/70
|
3.2%
2/62
|
10.0%
13/130
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/70
|
0.00%
0/62
|
8.5%
11/130
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.9%
2/70
|
0.00%
0/62
|
6.9%
9/130
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
1/70
|
1.6%
1/62
|
6.2%
8/130
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/70
|
0.00%
0/62
|
4.6%
6/130
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/70
|
0.00%
0/62
|
3.8%
5/130
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/70
|
0.00%
0/62
|
3.8%
5/130
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.4%
1/70
|
1.6%
1/62
|
3.1%
4/130
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid nodule
|
2.9%
2/70
|
1.6%
1/62
|
3.1%
4/130
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
4.3%
3/70
|
1.6%
1/62
|
3.1%
4/130
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/70
|
1.6%
1/62
|
2.3%
3/130
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/70
|
1.6%
1/62
|
2.3%
3/130
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/70
|
1.6%
1/62
|
1.5%
2/130
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Ligament disorder
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Plantar fascitis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/70
|
1.6%
1/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/70
|
1.6%
1/62
|
0.00%
0/130
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/70
|
1.6%
1/62
|
0.00%
0/130
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/70
|
1.6%
1/62
|
0.00%
0/130
|
|
Gastrointestinal disorders
Diarrhoea
|
12.9%
9/70
|
3.2%
2/62
|
16.9%
22/130
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/70
|
3.2%
2/62
|
9.2%
12/130
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
4/70
|
1.6%
1/62
|
7.7%
10/130
|
|
Gastrointestinal disorders
Gastritis
|
7.1%
5/70
|
0.00%
0/62
|
6.2%
8/130
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
2/70
|
3.2%
2/62
|
5.4%
7/130
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
1/70
|
0.00%
0/62
|
5.4%
7/130
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/70
|
1.6%
1/62
|
5.4%
7/130
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
1/70
|
0.00%
0/62
|
4.6%
6/130
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.4%
1/70
|
0.00%
0/62
|
3.8%
5/130
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/70
|
0.00%
0/62
|
3.8%
5/130
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.7%
4/70
|
0.00%
0/62
|
3.8%
5/130
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.4%
1/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/70
|
1.6%
1/62
|
2.3%
3/130
|
|
Gastrointestinal disorders
Cheilitis
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Barrett's Oesophagus
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Gingivitis
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/70
|
1.6%
1/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Oesophageal irritation
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Gastrointestinal disorders
Stomach discomfort
|
1.4%
1/70
|
0.00%
0/62
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Oropharnygeal pain
|
8.6%
6/70
|
1.6%
1/62
|
13.1%
17/130
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
2/70
|
1.6%
1/62
|
8.5%
11/130
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/70
|
3.2%
2/62
|
3.1%
4/130
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.4%
1/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
2.9%
2/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Pleural fibrosis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/70
|
1.6%
1/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
1.4%
1/70
|
0.00%
0/62
|
0.00%
0/130
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
4/70
|
3.2%
2/62
|
10.8%
14/130
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.4%
1/70
|
1.6%
1/62
|
5.4%
7/130
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/70
|
0.00%
0/62
|
3.1%
4/130
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
1.4%
1/70
|
1.6%
1/62
|
2.3%
3/130
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
1.4%
1/70
|
1.6%
1/62
|
2.3%
3/130
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.9%
2/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/70
|
1.6%
1/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Granuloma annulare
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/70
|
1.6%
1/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/70
|
1.6%
1/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/70
|
1.6%
1/62
|
0.00%
0/130
|
|
Injury, poisoning and procedural complications
Skin laceration
|
2.9%
2/70
|
0.00%
0/62
|
6.2%
8/130
|
|
Injury, poisoning and procedural complications
Contusion
|
1.4%
1/70
|
1.6%
1/62
|
4.6%
6/130
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/70
|
3.2%
2/62
|
4.6%
6/130
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/70
|
0.00%
0/62
|
3.1%
4/130
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/70
|
1.6%
1/62
|
2.3%
3/130
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
1.4%
1/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/70
|
3.2%
2/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Procedural headache
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
General disorders
Fatigue
|
2.9%
2/70
|
11.3%
7/62
|
8.5%
11/130
|
|
General disorders
Oedema peripheral
|
1.4%
1/70
|
0.00%
0/62
|
6.2%
8/130
|
|
General disorders
Chest pain
|
0.00%
0/70
|
0.00%
0/62
|
3.1%
4/130
|
|
General disorders
Pyrexia
|
1.4%
1/70
|
0.00%
0/62
|
3.1%
4/130
|
|
General disorders
Influenza like illness
|
0.00%
0/70
|
1.6%
1/62
|
2.3%
3/130
|
|
General disorders
Cyst
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
General disorders
Infusion related reaction
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
General disorders
Non-cardiac chest pain
|
2.9%
2/70
|
0.00%
0/62
|
1.5%
2/130
|
|
General disorders
Chills
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
General disorders
Feeling hot
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
General disorders
Impaired healing
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
General disorders
Infusion site rash
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
General disorders
Metaplasia
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
General disorders
Oedema
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
General disorders
Pain
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Nervous system disorders
Headache
|
5.7%
4/70
|
0.00%
0/62
|
11.5%
15/130
|
|
Nervous system disorders
Dizziness
|
2.9%
2/70
|
1.6%
1/62
|
6.9%
9/130
|
|
Nervous system disorders
Amnesia
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Nervous system disorders
Migraine
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Nervous system disorders
Aphasia
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Nervous system disorders
Lethargy
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Nervous system disorders
Tarsal tunnel syndrome
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Nervous system disorders
Tremor
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/70
|
1.6%
1/62
|
0.00%
0/130
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/70
|
1.6%
1/62
|
0.00%
0/130
|
|
Investigations
Hepatic enzyme increased
|
1.4%
1/70
|
1.6%
1/62
|
4.6%
6/130
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/70
|
0.00%
0/62
|
3.1%
4/130
|
|
Investigations
Cardiac murmur
|
0.00%
0/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Investigations
Transaminases increased
|
1.4%
1/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Investigations
Weight increased
|
0.00%
0/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Investigations
Aspartate amniotransferase increased
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Investigations
Blood triglycerides increased
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Investigations
Helicobacter test positive
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Investigations
White blood cell count decreased
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Investigations
Band neutrophil count increased
|
0.00%
0/70
|
1.6%
1/62
|
0.00%
0/130
|
|
Investigations
Helicobacter pylori identification test positive
|
1.4%
1/70
|
0.00%
0/62
|
0.00%
0/130
|
|
Investigations
Occult blood
|
0.00%
0/70
|
1.6%
1/62
|
0.00%
0/130
|
|
Vascular disorders
Hypertension
|
0.00%
0/70
|
1.6%
1/62
|
9.2%
12/130
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/70
|
1.6%
1/62
|
1.5%
2/130
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Vascular disorders
Flushing
|
1.4%
1/70
|
1.6%
1/62
|
0.77%
1/130
|
|
Vascular disorders
Hot flush
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Vascular disorders
Hypotension
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/70
|
1.6%
1/62
|
0.00%
0/130
|
|
Vascular disorders
Phlebitis
|
0.00%
0/70
|
1.6%
1/62
|
0.00%
0/130
|
|
Eye disorders
Cataract
|
0.00%
0/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Eye disorders
Dry eye
|
1.4%
1/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Eye disorders
Asthenopia
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Eye disorders
Conjunctivitis
|
1.4%
1/70
|
1.6%
1/62
|
0.77%
1/130
|
|
Eye disorders
Conjunctivitis allergic
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Eye disorders
Eye irritation
|
0.00%
0/70
|
1.6%
1/62
|
0.77%
1/130
|
|
Eye disorders
Eye swelling
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Eye disorders
Eyelid cyst
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Eye disorders
Glaucoma
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Eye disorders
Macular oedema
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Eye disorders
Retinal tear
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Eye disorders
Visual impairment
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Eye disorders
Myodesopsia
|
1.4%
1/70
|
0.00%
0/62
|
0.00%
0/130
|
|
Psychiatric disorders
Insomnia
|
1.4%
1/70
|
0.00%
0/62
|
6.9%
9/130
|
|
Psychiatric disorders
Depression
|
0.00%
0/70
|
6.5%
4/62
|
3.8%
5/130
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/70
|
1.6%
1/62
|
1.5%
2/130
|
|
Psychiatric disorders
Confusional state
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Psychiatric disorders
Libido increased
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Psychiatric disorders
Restlessness
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/70
|
0.00%
0/62
|
3.8%
5/130
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.4%
1/70
|
0.00%
0/62
|
3.1%
4/130
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.4%
1/70
|
1.6%
1/62
|
2.3%
3/130
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/70
|
1.6%
1/62
|
0.00%
0/130
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/70
|
0.00%
0/62
|
4.6%
6/130
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
1/70
|
0.00%
0/62
|
2.3%
3/130
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Blood and lymphatic system disorders
Lymph node calcification
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Blood and lymphatic system disorders
Splenic lesion
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Reproductive system and breast disorders
Breast calcifications
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Reproductive system and breast disorders
Genital ulceration
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Polymenorrhoea
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Respiratory, thoracic and mediastinal disorders
Uterine synechiae
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/70
|
1.6%
1/62
|
0.00%
0/130
|
|
Cardiac disorders
Palpitations
|
4.3%
3/70
|
0.00%
0/62
|
3.1%
4/130
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Cardiac disorders
Supraventricular extrasystoles
|
1.4%
1/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.4%
1/70
|
1.6%
1/62
|
2.3%
3/130
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/70
|
1.6%
1/62
|
0.77%
1/130
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/70
|
1.6%
1/62
|
1.5%
2/130
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Ear and labyrinth disorders
Ear pain
|
2.9%
2/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Surgical and medical procedures
Mole excision
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Surgical and medical procedures
Retinal operation
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Surgical and medical procedures
Rhinoplasty
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/70
|
1.6%
1/62
|
0.00%
0/130
|
|
Immune system disorders
Seasonal allergy
|
1.4%
1/70
|
1.6%
1/62
|
3.8%
5/130
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/70
|
1.6%
1/62
|
0.00%
0/130
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/70
|
0.00%
0/62
|
1.5%
2/130
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/70
|
0.00%
0/62
|
0.77%
1/130
|
|
Investigations
Blood pressure increased
|
1.4%
1/70
|
0.00%
0/62
|
0.77%
1/130
|
Additional Information
Medical Communications
Hoffman-LaRoche
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER