Trial Outcomes & Findings for A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis (NCT NCT01532869)
NCT ID: NCT01532869
Last Updated: 2016-09-23
Results Overview
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
87 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2016-09-23
Participant Flow
Randomization was stratified by joint involvement at baseline (\>=4 or \<4 tender joints of 28 tender joint count \[TJC\]). The study consisted of double-blind (Week 0-Week 48) and open-label (Week 48-Week 96) periods. Data analyzed up to Weeks 24 and 48 (data cut-off: 11 July 2014), and up to Week 96 (data cut-off: 05 August 2015) are reported.
Participant milestones
| Measure |
Placebo
Participants received tocilizumab (TCZ) matched placebo by subcutaneous (SC) injection every week (qw) for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 milligrams \[mg\]) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Blinded-Treatment Period (Up to Week 24)
STARTED
|
44
|
43
|
|
Blinded-Treatment Period (Up to Week 24)
COMPLETED
|
36
|
35
|
|
Blinded-Treatment Period (Up to Week 24)
NOT COMPLETED
|
8
|
8
|
|
Blinded-Treatment Period (Up to Week 48)
STARTED
|
44
|
43
|
|
Blinded-Treatment Period (Up to Week 48)
COMPLETED
|
33
|
30
|
|
Blinded-Treatment Period (Up to Week 48)
NOT COMPLETED
|
11
|
13
|
|
Open-label Period (Week 48 to Week 96)
STARTED
|
31
|
30
|
|
Open-label Period (Week 48 to Week 96)
COMPLETED
|
24
|
27
|
|
Open-label Period (Week 48 to Week 96)
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Participants received tocilizumab (TCZ) matched placebo by subcutaneous (SC) injection every week (qw) for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 milligrams \[mg\]) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Blinded-Treatment Period (Up to Week 24)
Death
|
0
|
1
|
|
Blinded-Treatment Period (Up to Week 24)
Adverse Event
|
2
|
3
|
|
Blinded-Treatment Period (Up to Week 24)
Lost to Follow-up
|
0
|
1
|
|
Blinded-Treatment Period (Up to Week 24)
Non-compliance
|
1
|
0
|
|
Blinded-Treatment Period (Up to Week 24)
Lack of Efficacy
|
1
|
1
|
|
Blinded-Treatment Period (Up to Week 24)
Withdrawal by Subject
|
4
|
2
|
|
Blinded-Treatment Period (Up to Week 48)
Death
|
0
|
3
|
|
Blinded-Treatment Period (Up to Week 48)
Adverse Event
|
4
|
5
|
|
Blinded-Treatment Period (Up to Week 48)
Lost to Follow-up
|
0
|
1
|
|
Blinded-Treatment Period (Up to Week 48)
Non-Compliance
|
1
|
0
|
|
Blinded-Treatment Period (Up to Week 48)
Lack of Efficacy
|
0
|
1
|
|
Blinded-Treatment Period (Up to Week 48)
Withdrawal by Subject
|
5
|
3
|
|
Blinded-Treatment Period (Up to Week 48)
Physician Decision
|
1
|
0
|
|
Open-label Period (Week 48 to Week 96)
Adverse Event
|
4
|
1
|
|
Open-label Period (Week 48 to Week 96)
Non-compliance
|
1
|
0
|
|
Open-label Period (Week 48 to Week 96)
Lack of Efficacy
|
1
|
1
|
|
Open-label Period (Week 48 to Week 96)
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis
Baseline characteristics by cohort
| Measure |
Placebo
n=44 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
n=43 Participants
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
51.2 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
49.6 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Intent-to-treat (ITT) population included all participants randomized who had received any study drug at the time of the Week 24 cutoff date (14 January 2014). Here, number of participants analyzed included only those participants who were evaluable for this outcome measure at any time point up to Week 24.
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
n=41 Participants
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24
|
-1.22 unit on a scale
Interval -3.42 to 0.98
|
-3.92 unit on a scale
Interval -6.17 to -1.67
|
PRIMARY outcome
Timeframe: Week 48Population: Safety population.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 8 after last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
n=43 Participants
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-emergent adverse events
|
90.9 percentage of participants
|
97.7 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-emergent serious adverse events
|
34.1 percentage of participants
|
32.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 48Population: ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and "n" included those who were evaluable for the specific item at specified time point in specified timeframe.
SHAQ-DI assessed five scleroderma-specific visual analogue scale (VAS) items to explore the impact of participant's disease. These items were developed to measure the effect of scleroderma on five elements of disease that could have a great impact on a participant's daily activities. Each VAS item was rated separately (0-100 millimeters \[mm\]), with higher scores indicating more severe disease. The five items were: 1) intestinal disease, 2) breathing problem, 3) Raynaud syndrome, 4) finger ulcers, and 5) overall disease.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
n=41 Participants
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)
Week 24: Intestinal VAS Score (n=42, 41)
|
5.81 mm
Interval -1.43 to 13.06
|
5.38 mm
Interval -1.98 to 12.74
|
|
Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)
Week 24: Breathing VAS Scores (n=42, 41)
|
8.54 mm
Interval 0.81 to 16.27
|
4.42 mm
Interval -3.47 to 12.31
|
|
Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)
Week 24: Raynaud syndrome (n=42, 41)
|
2.41 mm
Interval -6.96 to 11.78
|
1.13 mm
Interval -8.47 to 10.73
|
|
Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)
Week 24: Finger ulcers VAS Score (n=42, 41)
|
9.20 mm
Interval -0.22 to 18.61
|
14.09 mm
Interval 4.45 to 23.73
|
|
Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)
Week 24: Overall disease (n=42, 41)
|
1.89 mm
Interval -4.99 to 8.77
|
1.81 mm
Interval -5.21 to 8.84
|
|
Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)
Week 48: Intestinal VAS Score (n=41, 41)
|
7.91 mm
Interval -0.37 to 16.18
|
1.11 mm
Interval -6.88 to 9.1
|
|
Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)
Week 48: Breathing VAS Scores (n=41, 41)
|
0.55 mm
Interval -7.09 to 8.19
|
2.09 mm
Interval -5.39 to 9.57
|
|
Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)
Week 48: Raynaud syndrome (n=41, 41)
|
0.30 mm
Interval -9.51 to 10.12
|
-4.18 mm
Interval -13.87 to 5.51
|
|
Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)
Week 48: Finger ulcers VAS Score (n=41, 41)
|
4.97 mm
Interval -3.15 to 13.1
|
-0.83 mm
Interval -8.83 to 7.17
|
|
Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)
Week 48: Overall disease (n=41, 41)
|
3.46 mm
Interval -4.5 to 11.41
|
-4.36 mm
Interval -12.27 to 3.55
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 48Population: ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and "n" included those who were evaluable for the specific item at specified time point in specified time frame.
The HAQ-DI scale consisted of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The total score indicated the participant's self-assessed level of disability. There are four possible responses for each component: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The HAQ-DI was the sum of the domain scores, divided by the number of domains that have a score (i.e. the average score), with total range of 0 to 3, higher scores showing larger functional limitation.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
n=41 Participants
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 48
Week 24 (n=42, 41)
|
0.118 units on a scale
Interval -0.026 to 0.262
|
0.137 units on a scale
Interval -0.01 to 0.285
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 48
Week 48 (n=41, 41)
|
0.205 units on a scale
Interval 0.017 to 0.393
|
-0.002 units on a scale
Interval -0.188 to 0.183
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 48Population: ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and "n" included those who were evaluable for the specific item at specified time point in specified time frame.
The Clinician's Global Assessment evaluated the overall impact of SSc on the participant as assessed by the physician on a VAS with scores ranging from 0 to 100 mm, with higher scores indicating worse disease in terms of severity, damage, or overall disease, but there was no standardization for the scale.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
n=40 Participants
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Change From Baseline in Clinician's Global Assessment at Week 24 and Week 48
Week 24 (n=41, 39)
|
-7.25 mm
Interval -12.99 to -1.51
|
-8.24 mm
Interval -14.06 to -2.41
|
|
Change From Baseline in Clinician's Global Assessment at Week 24 and Week 48
Week 48 (n=41, 40)
|
-9.39 mm
Interval -16.66 to -2.12
|
-18.41 mm
Interval -25.3 to -11.52
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 48Population: ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and "n" included those who were evaluable for the specific item at specified time point in specified time frame.
The Patient's Global Assessment was a patient's reported outcome that represented the participant's overall assessment of his or her current SSc on a 100 mm horizontal VAS scale (0 mm to 100 mm), with higher scores indicating worsening disease.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
n=42 Participants
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Change From Baseline in Patient's Global Assessment at Week 24 and Week 48
Week 24 (n=42, 42)
|
1.53 mm
Interval -4.93 to 7.98
|
-2.33 mm
Interval -8.87 to 4.22
|
|
Change From Baseline in Patient's Global Assessment at Week 24 and Week 48
Week 48 (n=41, 42)
|
-2.70 mm
Interval -10.56 to 5.16
|
-11.00 mm
Interval -18.69 to -3.31
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 48Population: ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and "n" included those who were evaluable for the specific item at specified time point in specified time frame.
This FACIT-Fatigue Scale was a 13-item measure with participants scoring each item on a 5-point scale (0 to 4) up to 52 points. The endpoint measured was fatigue. On this scale, a numerical increase indicated an improvement in the participant's condition.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
n=42 Participants
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24 and Week 48
Week 24 (n=41, 42)
|
1.26 units on a scale
Interval -1.85 to 4.37
|
2.68 units on a scale
Interval -0.41 to 5.77
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24 and Week 48
Week 48 (n=40, 42)
|
0.36 units on a scale
Interval -2.64 to 3.37
|
3.11 units on a scale
Interval 0.28 to 5.95
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 48Population: ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and "n" included those who were evaluable for the specific item at specified time point in specified time frame.
The 5-D Itch Scale contained five domains of duration, degree, direction, disability, and distribution. The endpoint of the scale was pruritus. Each domain was scored on a 5-point scale, the scores of each of the five domains were achieved separately and then summed together to obtain a total 5-D score. 5-D scores ranged between 5 (no pruritus) and 25 (most severe pruritus).
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
n=41 Participants
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Change From Baseline in 5-D Itch Scale at Week 24 and Week 48
Week 24 (n=41, 41)
|
-1.73 units on a scale
Interval -2.95 to -0.5
|
-0.94 units on a scale
Interval -2.15 to 0.28
|
|
Change From Baseline in 5-D Itch Scale at Week 24 and Week 48
Week 48 (n=40, 41)
|
-1.08 units on a scale
Interval -2.6 to 0.43
|
-2.19 units on a scale
Interval -3.58 to -0.8
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure at specified time point up to 48 weeks.
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
n=41 Participants
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Change From Baseline in mRSS at Week 48
|
-2.77 unit on a scale
Interval -5.44 to -0.11
|
-6.33 unit on a scale
Interval -8.86 to -3.79
|
SECONDARY outcome
Timeframe: Week 48Population: ITT population. Here number of participants analyzed included those with mRSS change from baseline \<0 at Week 24 and with non-missing change from baseline in mRSS at Week 48.
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement. Percentage of participants with an improvement in mRSS at Week 24 (change from baseline \<0) that maintained or further improved at Week 48 were reported as "Yes" and "No" with Yes = improvers at week 24 that had a change from baseline in mRSS at Week 48 \<= change from baseline at Week 24.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
n=41 Participants
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Percentage of Participants Who Maintained or Improved in mRSS From Week 24 to Week 48
|
44.4 percentage of participants
|
68.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 8, 16, 24, 32, 40, and 48Population: ITT population. Here, "n" = participants evaluable for the specific item at specified time point in specified time frame.
Joint tenderness was evaluated as per assessment of 28 joints. Joints on both sides of the body, including shoulders, elbows, wrists, 10 metacarpal phalangeal (MCP) joints, 10 proximal interphalangeal joint (PIP) joints, and both knees, were assessed. Joints were classified as not tender = 0 or tender = 1. Observed data was presented for this outcome measure.
Outcome measures
| Measure |
Placebo
n=20 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
n=19 Participants
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Change From Baseline in Tender Joint Count 28 (TJC28)
Week 3 (n=20, 19)
|
-2.75 joint count
Standard Deviation 4.27
|
-2.32 joint count
Standard Deviation 5.55
|
|
Change From Baseline in Tender Joint Count 28 (TJC28)
Week 8 (n=18, 19)
|
-3.06 joint count
Standard Deviation 6.67
|
-4.00 joint count
Standard Deviation 6.16
|
|
Change From Baseline in Tender Joint Count 28 (TJC28)
Week 16 (n=18, 17)
|
-3.50 joint count
Standard Deviation 6.00
|
-3.65 joint count
Standard Deviation 7.59
|
|
Change From Baseline in Tender Joint Count 28 (TJC28)
Week 24 (n=17, 16)
|
-2.06 joint count
Standard Deviation 6.28
|
-4.31 joint count
Standard Deviation 7.34
|
|
Change From Baseline in Tender Joint Count 28 (TJC28)
Week 32 (n=12, 11)
|
-3.33 joint count
Standard Deviation 6.62
|
-3.18 joint count
Standard Deviation 7.40
|
|
Change From Baseline in Tender Joint Count 28 (TJC28)
Week 40 (n=10, 10)
|
-3.80 joint count
Standard Deviation 6.76
|
-4.30 joint count
Standard Deviation 8.23
|
|
Change From Baseline in Tender Joint Count 28 (TJC28)
Week 48 (n=12, 10)
|
-2.92 joint count
Standard Deviation 7.08
|
-5.10 joint count
Standard Deviation 7.29
|
SECONDARY outcome
Timeframe: Pre-dose, 24, 48, 72, 96, 120 or 144, and 168 hours post dose for Baseline and Week 16Population: Pharmacokinetic (PK) population included all participants who received at least one TCZ injection and had at least one PK sample with detectable results. Here, "n" = participants evaluable for the specific item at specified time point in specified time frame.
AUC was a measure of the serum concentration of the drug over time which was measured in micrograms times (\*) hour per milliliters (µg\*hr/mL). It is used to characterize drug absorption.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Area Under the Concentration-Time Curve (AUC) From Time 0 to 168 Hour (AUC0-168)
Baseline (n=7)
|
686 µg*hr/mL
Standard Deviation 455
|
—
|
|
Area Under the Concentration-Time Curve (AUC) From Time 0 to 168 Hour (AUC0-168)
Week 16 (n=4)
|
7508 µg*hr/mL
Standard Deviation 2369
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48Population: Safety population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and "n" included those who were evaluable for the specific item at specified time point in specified time frame.
Observed data was presented for this outcome measure.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
n=43 Participants
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Baseline (n=43, 42)
|
15.02 picograms per milliliters (pg/mL)
Standard Deviation 18.19
|
13.57 picograms per milliliters (pg/mL)
Standard Deviation 14.69
|
|
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Week 1: Absolute values (n=43, 43)
|
17.24 picograms per milliliters (pg/mL)
Standard Deviation 22.77
|
158.91 picograms per milliliters (pg/mL)
Standard Deviation 326.42
|
|
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Week 1: Change From Baseline (n=42, 42)
|
1.33 picograms per milliliters (pg/mL)
Standard Deviation 27.29
|
147.37 picograms per milliliters (pg/mL)
Standard Deviation 326.20
|
|
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Week 2: Absolute values (n=43, 41)
|
12.60 picograms per milliliters (pg/mL)
Standard Deviation 13.78
|
107.10 picograms per milliliters (pg/mL)
Standard Deviation 73.75
|
|
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Week 2: Change From Baseline (n=42, 40)
|
-3.07 picograms per milliliters (pg/mL)
Standard Deviation 17.85
|
94.54 picograms per milliliters (pg/mL)
Standard Deviation 67.99
|
|
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Week 3: Absolute values (n=42, 40)
|
12.47 picograms per milliliters (pg/mL)
Standard Deviation 10.72
|
116.58 picograms per milliliters (pg/mL)
Standard Deviation 75.31
|
|
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Week 3: Change From Baseline (n=41, 39)
|
-3.60 picograms per milliliters (pg/mL)
Standard Deviation 15.28
|
104.44 picograms per milliliters (pg/mL)
Standard Deviation 71.84
|
|
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Week 8: Absolute values (n=42, 39)
|
15.39 picograms per milliliters (pg/mL)
Standard Deviation 19.04
|
115.31 picograms per milliliters (pg/mL)
Standard Deviation 66.39
|
|
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Week 8: Change From Baseline(n=41,38)
|
0.15 picograms per milliliters (pg/mL)
Standard Deviation 18.65
|
104.14 picograms per milliliters (pg/mL)
Standard Deviation 62.95
|
|
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Week 16: Absolute values (n=32,33)
|
12.51 picograms per milliliters (pg/mL)
Standard Deviation 14.06
|
98.36 picograms per milliliters (pg/mL)
Standard Deviation 61.65
|
|
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Week 16: Change From Baseline (n=31,32)
|
-1.26 picograms per milliliters (pg/mL)
Standard Deviation 11.34
|
88.86 picograms per milliliters (pg/mL)
Standard Deviation 59.77
|
|
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Week 24: Absolute values (n=36,34)
|
10.19 picograms per milliliters (pg/mL)
Standard Deviation 10.55
|
84.67 picograms per milliliters (pg/mL)
Standard Deviation 68.37
|
|
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Week 24: Change From Baseline(n=35,33)
|
-2.74 picograms per milliliters (pg/mL)
Standard Deviation 12.43
|
73.61 picograms per milliliters (pg/mL)
Standard Deviation 68.07
|
|
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Week 48: Absolute values (n=32,27)
|
10.50 picograms per milliliters (pg/mL)
Standard Deviation 11.82
|
65.30 picograms per milliliters (pg/mL)
Standard Deviation 35.95
|
|
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Week 48: Change From Baseline (n=31,26)
|
-2.61 picograms per milliliters (pg/mL)
Standard Deviation 14.92
|
55.60 picograms per milliliters (pg/mL)
Standard Deviation 35.86
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48Population: Safety population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and "n" included those who were evaluable for the specific item at specified time point in specified time frame.
Observed data was presented for this outcome measure.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
n=43 Participants
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Baseline (n=44, 42)
|
37.61 pg/mL
Standard Deviation 11.12
|
39.39 pg/mL
Standard Deviation 10.16
|
|
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Week 1: Absolute values (n=44, 43)
|
51.03 pg/mL
Standard Deviation 59.12
|
237.34 pg/mL
Standard Deviation 71.38
|
|
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Week 1: Change From Baseline (n=44, 42)
|
13.42 pg/mL
Standard Deviation 57.91
|
198.39 pg/mL
Standard Deviation 69.41
|
|
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Week 2: Absolute values (n=43, 41)
|
44.07 pg/mL
Standard Deviation 42.15
|
329.90 pg/mL
Standard Deviation 81.93
|
|
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Week 2: Change From Baseline (n=43, 40)
|
6.13 pg/mL
Standard Deviation 41.60
|
291.38 pg/mL
Standard Deviation 79.29
|
|
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Week 3: Absolute values (n=44, 40)
|
41.64 pg/mL
Standard Deviation 27.07
|
384.88 pg/mL
Standard Deviation 99.41
|
|
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Week 3: Change From Baseline (n=44, 39)
|
4.03 pg/mL
Standard Deviation 26.00
|
346.68 pg/mL
Standard Deviation 95.96
|
|
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Week 8: Absolute values (n=42, 39)
|
38.66 pg/mL
Standard Deviation 11.95
|
486.62 pg/mL
Standard Deviation 116.41
|
|
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Week 8: Change From Baseline (n=42, 38)
|
0.91 pg/mL
Standard Deviation 5.07
|
447.77 pg/mL
Standard Deviation 114.40
|
|
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Week 16: Absolute values (n=32, 33)
|
37.71 pg/mL
Standard Deviation 10.30
|
525.48 pg/mL
Standard Deviation 164.90
|
|
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Week 16: Change From Baseline (n=32, 32)
|
-0.08 pg/mL
Standard Deviation 5.71
|
486.43 pg/mL
Standard Deviation 163.32
|
|
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Week 24: Absolute values (n=36, 34)
|
38.72 pg/mL
Standard Deviation 13.06
|
520.18 pg/mL
Standard Deviation 167.97
|
|
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Week 24: Change From Baseline (n=36, 33)
|
1.11 pg/mL
Standard Deviation 6.47
|
482.10 pg/mL
Standard Deviation 168.44
|
|
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Week 48: Absolute values (n=32, 27)
|
36.52 pg/mL
Standard Deviation 9.93
|
491.44 pg/mL
Standard Deviation 164.82
|
|
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Week 48: Change From Baseline (n=32, 26)
|
-0.75 pg/mL
Standard Deviation 5.20
|
454.19 pg/mL
Standard Deviation 163.93
|
SECONDARY outcome
Timeframe: Baseline, and post-baseline (up to Week 48)Population: Safety population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
|
Tocilizumab
n=42 Participants
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
|
|---|---|---|
|
Percentage of Participants With Anti-Tocilizumab Antibody
Baseline
|
7.0 percentage of participants
|
2.4 percentage of participants
|
|
Percentage of Participants With Anti-Tocilizumab Antibody
Post-Baseline
|
0.0 percentage of participants
|
2.4 percentage of participants
|
Adverse Events
Placebo (up to 24 Weeks)
Serious events: 11 serious events
Other events: 26 other events
Deaths: 0 deaths
Tocilizumab (up to 24 Weeks)
Serious events: 9 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo (up to 48 Weeks)
Serious events: 15 serious events
Other events: 32 other events
Deaths: 0 deaths
Tocilizumab (up to 48 Weeks)
Serious events: 14 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo to Tocilizumab (up to 96 Weeks)
Serious events: 22 serious events
Other events: 39 other events
Deaths: 0 deaths
Tocilizumab to Tocilizumab (up to 96 Weeks)
Serious events: 17 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (up to 24 Weeks)
n=44 participants at risk
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for placebo up to Week 24 are presented in this reporting group.
|
Tocilizumab (up to 24 Weeks)
n=43 participants at risk
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for TCZ up to Week 24 was presented in this reporting group.
|
Placebo (up to 48 Weeks)
n=44 participants at risk
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for placebo up to Week 48 are presented in this reporting group.
|
Tocilizumab (up to 48 Weeks)
n=43 participants at risk
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for TCZ up to Week 48 are presented in this reporting group.
|
Placebo to Tocilizumab (up to 96 Weeks)
n=44 participants at risk
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for double-blind placebo to open-label tocilizumab up to Week 96 are presented in this reporting group.
|
Tocilizumab to Tocilizumab (up to 96 Weeks)
n=43 participants at risk
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for double-blind tocilizumab to open-label tocilizumab up to Week 96 are presented in this reporting group.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Cardiac disorders
Acute myocardial infarction
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Cardiac disorders
Cardiac failure
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Cardiac disorders
Cyanosis
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Gastrointestinal disorders
Colonic pseudo-obstruction
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Gastrointestinal disorders
Retroperitoneal fibrosis
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
General disorders
Impaired healing
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
General disorders
Multi-organ failure
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Bronchitis
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Cellulitis
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.7%
2/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Lower respiratory tract infection
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Lung infection
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.7%
2/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.7%
2/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.7%
2/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Pneumonia
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Sepsis
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Musculoskeletal and connective tissue disorders
Systemic sclerosis
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Nervous system disorders
Headache
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Renal and urinary disorders
Renal failure acute
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Renal and urinary disorders
Scleroderma renal crisis
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.7%
2/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.7%
2/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Vascular disorders
Hypertension
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Vascular disorders
Hypertensive emergency
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Vascular disorders
Raynaud's phenomenon
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Appendicitis
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Device related infection
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
Other adverse events
| Measure |
Placebo (up to 24 Weeks)
n=44 participants at risk
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for placebo up to Week 24 are presented in this reporting group.
|
Tocilizumab (up to 24 Weeks)
n=43 participants at risk
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for TCZ up to Week 24 was presented in this reporting group.
|
Placebo (up to 48 Weeks)
n=44 participants at risk
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for placebo up to Week 48 are presented in this reporting group.
|
Tocilizumab (up to 48 Weeks)
n=43 participants at risk
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for TCZ up to Week 48 are presented in this reporting group.
|
Placebo to Tocilizumab (up to 96 Weeks)
n=44 participants at risk
Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for double-blind placebo to open-label tocilizumab up to Week 96 are presented in this reporting group.
|
Tocilizumab to Tocilizumab (up to 96 Weeks)
n=43 participants at risk
Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for double-blind tocilizumab to open-label tocilizumab up to Week 96 are presented in this reporting group.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
9.3%
4/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
4/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
14.0%
6/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
9.1%
4/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
16.3%
7/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.4%
5/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
27.9%
12/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.1%
4/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
9.3%
4/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.4%
5/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.6%
5/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
15.9%
7/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.6%
5/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.7%
2/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.4%
5/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
General disorders
Asthenia
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
General disorders
Fatigue
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
9.3%
4/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.6%
5/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
14.0%
6/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
General disorders
Oedema peripheral
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
9.3%
4/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
9.3%
4/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Infected skin ulcer
|
11.4%
5/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.4%
5/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
15.9%
7/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
9.1%
4/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.6%
5/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.4%
5/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
18.6%
8/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
13.6%
6/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
18.2%
8/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Urinary tract infection
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.7%
2/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.4%
5/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
14.0%
6/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.6%
6/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
14.0%
6/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
18.2%
8/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
14.0%
6/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
22.7%
10/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
14.0%
6/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.6%
5/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
14.0%
6/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
18.6%
8/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.6%
5/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.6%
5/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
16.3%
7/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Nervous system disorders
Dizziness
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.6%
5/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Nervous system disorders
Headache
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.6%
5/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.4%
5/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
18.6%
8/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
4/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.7%
2/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
9.3%
4/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.6%
5/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
16.3%
7/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
9.1%
4/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
18.6%
8/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
20.5%
9/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
27.9%
12/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
13.6%
6/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
14.0%
6/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
15.9%
7/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
16.3%
7/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
20.5%
9/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
18.6%
8/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Vascular disorders
Hypertension
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.7%
2/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
9.1%
4/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Vascular disorders
Raynaud's phenomenon
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
11.6%
5/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
14.0%
6/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
9.1%
4/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.7%
2/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.7%
2/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
General disorders
Injection site erythema
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.5%
2/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Cellulitis
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
4.7%
2/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
9.3%
4/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
6.8%
3/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
2.3%
1/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
0.00%
0/44 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
7.0%
3/43 • Up to Week 96 (reporting groups up to 24 Weeks and up to 48 Weeks present data as of the 11 July 2014 data cut-off date; reporting groups up to 96 weeks present data as of the 05 August 2015 data cut-off date).
MedDRA 17.0 was utilized up to Week 48; MedDRA 18.0 was utilized for Week 48 up to Week 96
|
Additional Information
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