Trial Outcomes & Findings for Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults (NCT NCT00534495)
NCT ID: NCT00534495
Last Updated: 2015-12-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
At Week 12
Results posted on
2015-12-11
Participant Flow
71 participants enrolled. 1 participant was erroneously randomized and was not included in the analysis. This patient was not exposed to study drug
Participant milestones
| Measure |
Rilonacept
Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week followed by a placebo loading dose and then rilonacept in the long term extension phase Rilonacept: 2.2 mg/kg subcutaneously
|
Placebo
Placebo loading dose followed by maintenance dose for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the long term extension
Rilonacept: 2.2 mg/kg subcutaneously
|
Long Term Extension All Participants
All participants who benefited from rilonacept were eligible to enroll this phase and receive rilonacept 2.2mg/kg weekly
|
|---|---|---|---|
|
Double Blind Placebo Phase Week 0-4
STARTED
|
36
|
35
|
0
|
|
Double Blind Placebo Phase Week 0-4
COMPLETED
|
36
|
34
|
0
|
|
Double Blind Placebo Phase Week 0-4
NOT COMPLETED
|
0
|
1
|
0
|
|
All Active Treatment Phase Week 4-24
STARTED
|
36
|
34
|
0
|
|
All Active Treatment Phase Week 4-24
COMPLETED
|
32
|
25
|
0
|
|
All Active Treatment Phase Week 4-24
NOT COMPLETED
|
4
|
9
|
0
|
|
Long Term Ext. Phase Week 24-month 21
STARTED
|
0
|
0
|
40
|
|
Long Term Ext. Phase Week 24-month 21
COMPLETED
|
0
|
0
|
29
|
|
Long Term Ext. Phase Week 24-month 21
NOT COMPLETED
|
0
|
0
|
11
|
Reasons for withdrawal
| Measure |
Rilonacept
Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week followed by a placebo loading dose and then rilonacept in the long term extension phase Rilonacept: 2.2 mg/kg subcutaneously
|
Placebo
Placebo loading dose followed by maintenance dose for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the long term extension
Rilonacept: 2.2 mg/kg subcutaneously
|
Long Term Extension All Participants
All participants who benefited from rilonacept were eligible to enroll this phase and receive rilonacept 2.2mg/kg weekly
|
|---|---|---|---|
|
Double Blind Placebo Phase Week 0-4
randomized in error
|
0
|
1
|
0
|
|
All Active Treatment Phase Week 4-24
Adverse Event
|
1
|
0
|
0
|
|
All Active Treatment Phase Week 4-24
Lack of Efficacy
|
1
|
7
|
0
|
|
All Active Treatment Phase Week 4-24
Lost to Follow-up
|
1
|
1
|
0
|
|
All Active Treatment Phase Week 4-24
Withdrawal by Subject
|
1
|
1
|
0
|
|
Long Term Ext. Phase Week 24-month 21
Adverse Event
|
0
|
0
|
1
|
|
Long Term Ext. Phase Week 24-month 21
Lack of Efficacy
|
0
|
0
|
5
|
|
Long Term Ext. Phase Week 24-month 21
Withdrawal by Subject
|
0
|
0
|
3
|
|
Long Term Ext. Phase Week 24-month 21
non compliance
|
0
|
0
|
2
|
Baseline Characteristics
Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults
Baseline characteristics by cohort
| Measure |
Rilonacept
n=36 Participants
Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Placebo
n=35 Participants
Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.5 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
10.5 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
10 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Disease Duration
|
2.6 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
2.6 years
STANDARD_DEVIATION 3.1 • n=7 Participants
|
2.6 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
No.of joints with active disease
|
11.7 joints
STANDARD_DEVIATION 9.6 • n=5 Participants
|
10.5 joints
STANDARD_DEVIATION 7.6 • n=7 Participants
|
11.1 joints
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Prior medications
Corticosteroids
|
30 participants
n=5 Participants
|
33 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Prior medications
Methotrexate
|
21 participants
n=5 Participants
|
26 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Prior medications
Leflunomide
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Prior medications
Infliximab
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Prior medications
Etanercept
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Prior medications
Abatacept
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Prior medications
Anakinra
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Prior medications
unknown Anakinra
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Disease characteristics in the past
Incomplete Macrophage Activation Syndrome
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Disease characteristics in the past
Complete Macrophage Activation Syndrome
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Disease characteristics in the past
Serositis
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Disease characteristics in the past
Systemic JIA rash
|
32 participants
n=5 Participants
|
33 participants
n=7 Participants
|
65 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 12Outcome measures
| Measure |
Rilonacept
n=36 Participants
Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Placebo
n=35 Participants
Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Week 24- All Subjects
|
|---|---|---|---|
|
Time to Response to Treatment, as Determined by a Modified JIA ACR30 Requiring no Fever, Coupled With a Requirement for Corticosteroid Taper in Participants Who Are Taking Corticosteroids
|
4 weeks
Interval 2.0 to 10.0
|
8 weeks
Interval 6.0 to
not estimable too few events
|
—
|
PRIMARY outcome
Timeframe: At Weeks 0- 24Outcome measures
| Measure |
Rilonacept
n=36 Participants
Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Placebo
n=35 Participants
Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Week 24- All Subjects
n=40 Participants
|
|---|---|---|---|
|
Number of Serious Adverse Events,Adverse Events, Infections, Development of MAS
Serious Adverse Events
|
4 events
|
2 events
|
8 events
|
|
Number of Serious Adverse Events,Adverse Events, Infections, Development of MAS
Adverse Events
|
98 events
|
186 events
|
110 events
|
|
Number of Serious Adverse Events,Adverse Events, Infections, Development of MAS
Infections
|
27 events
|
31 events
|
37 events
|
|
Number of Serious Adverse Events,Adverse Events, Infections, Development of MAS
MAS
|
1 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: At Week 4 and week 12Population: Participants in the study at week 4 (rilonacept 35 and placebo 33).Participants in the study at week 12 ( Rilonacept 33 and placebo 29).
Outcome measures
| Measure |
Rilonacept
n=35 Participants
Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Placebo
n=33 Participants
Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Week 24- All Subjects
|
|---|---|---|---|
|
Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70
week 4 ,ACR 50
|
21 participants
|
10 participants
|
—
|
|
Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70
week 12, ACR 50
|
26 participants
|
13 participants
|
—
|
|
Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70
week 4 ,ACR 70
|
21 participants
|
10 participants
|
—
|
|
Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70
week 12,ACR 70
|
28 participants
|
19 participants
|
—
|
SECONDARY outcome
Timeframe: At Weeks 4, 12 and 24Population: At Week 4 ,36 Rilonacept and 34 Placebo patient. At week 12, Rilonacept 33 patients and Placebo 29.At baseline Rilonacept 36 and Placebo 35 participants.
Visual Analog Score (0-100 mm) 0 very well , 100 very poor
Outcome measures
| Measure |
Rilonacept
n=36 Participants
Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Placebo
n=35 Participants
Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Week 24- All Subjects
n=57 Participants
|
|---|---|---|---|
|
Pediatric Quality of Life Inventory
week 12
|
3.5 units on a scale
Interval 0.0 to 17.0
|
8 units on a scale
Interval 2.0 to 38.0
|
NA units on a scale
At week 24 both arms were combined
|
|
Pediatric Quality of Life Inventory
week 4
|
12 units on a scale
Interval 3.0 to 23.0
|
34 units on a scale
Interval 15.0 to 67.0
|
NA units on a scale
At week 24 both arms were combined
|
|
Pediatric Quality of Life Inventory
week 24
|
NA units on a scale
At week 24 both arms were combined
|
NA units on a scale
At week 24 both arms were combined
|
7 units on a scale
Interval 1.0 to 29.0
|
|
Pediatric Quality of Life Inventory
baseline
|
49.5 units on a scale
Interval 33.0 to 65.0
|
53.0 units on a scale
Interval 28.0 to 68.0
|
NA units on a scale
At week 24 both arms were combined
|
SECONDARY outcome
Timeframe: At Weeks 12 and 24Population: 36 Rilonacept and 35 placebo at baseline , 36 Rilonacept and 34 placebo at week 4, 33 Rilonacept and 29 placebo at week 12, and 57 combined at week 24.
Childhood Health Assesment Questionairre dissability index (C-HAQ)-DI, Disability Index Calculation: The index is calculated by adding the scores for each of the categories and dividing by the number of categories answered. This gives a score in the 0 to 3.0 range. lower is better
Outcome measures
| Measure |
Rilonacept
n=36 Participants
Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Placebo
n=35 Participants
Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Week 24- All Subjects
n=57 Participants
|
|---|---|---|---|
|
Physical Function as Determined by Childhood Health Assessment Questionnaire ( CHAQ)
week 4
|
0.43 units on a scale
Interval 0.0 to 1.13
|
0.88 units on a scale
Interval 0.38 to 1.63
|
NA units on a scale
Groups were combined at week 24
|
|
Physical Function as Determined by Childhood Health Assessment Questionnaire ( CHAQ)
week 12
|
0.25 units on a scale
Interval 0.0 to 0.88
|
0.25 units on a scale
Interval 0.0 to 1.25
|
NA units on a scale
Groups were combined at week 24
|
|
Physical Function as Determined by Childhood Health Assessment Questionnaire ( CHAQ)
week 24
|
NA units on a scale
Groups were combined at week 24
|
NA units on a scale
Groups were combined at week 24
|
0.13 units on a scale
Interval 0.0 to 1.0
|
|
Physical Function as Determined by Childhood Health Assessment Questionnaire ( CHAQ)
baseline
|
1.00 units on a scale
Interval 0.75 to 1.63
|
1.25 units on a scale
Interval 0.5 to 1.63
|
NA units on a scale
Groups were combined at week 24
|
SECONDARY outcome
Timeframe: At Weeks 4, 12 and 24Population: At week 4 ,Rilonacept 36 and Placebo 34 participants , at week 12 , Rilonacept 33 and 29 Placebo participants , and at week 24 combined group with 57 participants, at baseline Rilonacept 36 and Placebo 35 participants.
Outcome measures
| Measure |
Rilonacept
n=36 Participants
Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Placebo
n=35 Participants
Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Week 24- All Subjects
n=57 Participants
|
|---|---|---|---|
|
Number of Participants With Presence of Systemic Features ( Fever, Rash)
Fever at week 4
|
3 participants
|
5 participants
|
NA participants
data not collected
|
|
Number of Participants With Presence of Systemic Features ( Fever, Rash)
Rash at week 4
|
3 participants
|
8 participants
|
NA participants
data not collected
|
|
Number of Participants With Presence of Systemic Features ( Fever, Rash)
Fever at week12
|
4 participants
|
1 participants
|
NA participants
data not collected
|
|
Number of Participants With Presence of Systemic Features ( Fever, Rash)
Rash at week 12
|
3 participants
|
1 participants
|
NA participants
data not collected
|
|
Number of Participants With Presence of Systemic Features ( Fever, Rash)
week 24 Fever
|
NA participants
not collected
|
NA participants
not collected
|
NA participants
not collected
|
|
Number of Participants With Presence of Systemic Features ( Fever, Rash)
week 24 Rash
|
NA participants
both groups were combined at 24 weeks
|
NA participants
both groups were combined at 24 weeks
|
4 participants
|
|
Number of Participants With Presence of Systemic Features ( Fever, Rash)
baseline Fever
|
10 participants
|
6 participants
|
NA participants
data not collected
|
|
Number of Participants With Presence of Systemic Features ( Fever, Rash)
beseline Rash
|
15 participants
|
15 participants
|
NA participants
data not collected
|
Adverse Events
Rilonacept Week (0-4)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo Week (0-4)
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Rilonacept Week (4-24)
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo Week (4-24)
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Long Term Extension 24 Weeks to 21 Months
Serious events: 6 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rilonacept Week (0-4)
n=36 participants at risk
Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Placebo Week (0-4)
n=35 participants at risk
Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Rilonacept Week (4-24)
n=35 participants at risk
Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Placebo Week (4-24)
n=33 participants at risk
Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Long Term Extension 24 Weeks to 21 Months
n=40 participants at risk
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Juvenile Arthritis
|
2.8%
1/36
|
2.9%
1/35
|
0.00%
0/35
|
3.0%
1/33
|
2.5%
1/40
|
|
Gastrointestinal disorders
Abnormal Liver Function Test
|
0.00%
0/36
|
0.00%
0/35
|
2.9%
1/35
|
0.00%
0/33
|
0.00%
0/40
|
|
Infections and infestations
Pyrexia
|
0.00%
0/36
|
0.00%
0/35
|
2.9%
1/35
|
0.00%
0/33
|
0.00%
0/40
|
|
Infections and infestations
Variccela
|
0.00%
0/36
|
0.00%
0/35
|
2.9%
1/35
|
0.00%
0/33
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Viral uper respiratory tract infestion
|
0.00%
0/36
|
0.00%
0/35
|
0.00%
0/35
|
0.00%
0/33
|
2.5%
1/40
|
|
Psychiatric disorders
Mental status Changes
|
0.00%
0/36
|
0.00%
0/35
|
0.00%
0/35
|
0.00%
0/33
|
2.5%
1/40
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/36
|
0.00%
0/35
|
0.00%
0/35
|
0.00%
0/33
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Pharingitis,Streptoccocal
|
0.00%
0/36
|
0.00%
0/35
|
0.00%
0/35
|
0.00%
0/33
|
2.5%
1/40
|
|
Gastrointestinal disorders
Gastroenteritis ,Salmonela
|
0.00%
0/36
|
0.00%
0/35
|
0.00%
0/35
|
0.00%
0/33
|
2.5%
1/40
|
|
Blood and lymphatic system disorders
Histiocytosis,hematophagic
|
0.00%
0/36
|
0.00%
0/35
|
0.00%
0/35
|
0.00%
0/33
|
2.5%
1/40
|
Other adverse events
| Measure |
Rilonacept Week (0-4)
n=36 participants at risk
Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Placebo Week (0-4)
n=35 participants at risk
Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Rilonacept Week (4-24)
n=35 participants at risk
Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Placebo Week (4-24)
n=33 participants at risk
Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study
Rilonacept: 2.2 mg/kg subcutaneously
|
Long Term Extension 24 Weeks to 21 Months
n=40 participants at risk
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain ,upper
|
2.8%
1/36
|
5.7%
2/35
|
8.6%
3/35
|
3.0%
1/33
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/36
|
2.9%
1/35
|
5.7%
2/35
|
18.2%
6/33
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/36
|
2.9%
1/35
|
5.7%
2/35
|
9.1%
3/33
|
5.0%
2/40
|
|
General disorders
Headache
|
2.8%
1/36
|
17.1%
6/35
|
2.9%
1/35
|
12.1%
4/33
|
7.5%
3/40
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/36
|
2.9%
1/35
|
2.9%
1/35
|
6.1%
2/33
|
7.5%
3/40
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis,Streptococcal
|
0.00%
0/36
|
0.00%
0/35
|
5.7%
2/35
|
6.1%
2/33
|
10.0%
4/40
|
|
Infections and infestations
Pyrexia
|
0.00%
0/36
|
2.9%
1/35
|
14.3%
5/35
|
3.0%
1/33
|
2.5%
1/40
|
|
Immune system disorders
Rash
|
5.6%
2/36
|
2.9%
1/35
|
2.9%
1/35
|
9.1%
3/33
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory tract infection
|
0.00%
0/36
|
2.9%
1/35
|
14.3%
5/35
|
27.3%
9/33
|
5.0%
2/40
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
1/36
|
5.7%
2/35
|
2.9%
1/35
|
6.1%
2/33
|
10.0%
4/40
|
|
General disorders
injection site reaction
|
5.6%
2/36
|
20.0%
7/35
|
5.7%
2/35
|
9.1%
3/33
|
0.00%
0/40
|
|
Investigations
Body temperature increased
|
0.00%
0/36
|
5.7%
2/35
|
8.6%
3/35
|
6.1%
2/33
|
0.00%
0/40
|
|
Infections and infestations
Urinary tract infections
|
0.00%
0/36
|
0.00%
0/35
|
8.6%
3/35
|
3.0%
1/33
|
0.00%
0/40
|
|
General disorders
Fatigue
|
0.00%
0/36
|
2.9%
1/35
|
2.9%
1/35
|
6.1%
2/33
|
0.00%
0/40
|
|
General disorders
Non Cardiac chest pain
|
0.00%
0/36
|
8.6%
3/35
|
2.9%
1/35
|
12.1%
4/33
|
0.00%
0/40
|
|
General disorders
Pain
|
0.00%
0/36
|
2.9%
1/35
|
0.00%
0/35
|
6.1%
2/33
|
5.0%
2/40
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorea
|
2.8%
1/36
|
2.9%
1/35
|
5.7%
2/35
|
12.1%
4/33
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/36
|
0.00%
0/35
|
5.7%
2/35
|
6.1%
2/33
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/36
|
2.9%
1/35
|
0.00%
0/35
|
6.1%
2/33
|
0.00%
0/40
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/36
|
0.00%
0/35
|
8.6%
3/35
|
3.0%
1/33
|
7.5%
3/40
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/36
|
0.00%
0/35
|
0.00%
0/35
|
6.1%
2/33
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/36
|
0.00%
0/35
|
0.00%
0/35
|
6.1%
2/33
|
7.5%
3/40
|
|
Skin and subcutaneous tissue disorders
dry skin
|
2.8%
1/36
|
0.00%
0/35
|
2.9%
1/35
|
6.1%
2/33
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/36
|
5.7%
2/35
|
2.9%
1/35
|
6.1%
2/33
|
0.00%
0/40
|
|
Nervous system disorders
Dizziness
|
0.00%
0/36
|
2.9%
1/35
|
0.00%
0/35
|
6.1%
2/33
|
0.00%
0/40
|
|
Investigations
Blood fibrinogen dicreased
|
0.00%
0/36
|
0.00%
0/35
|
0.00%
0/35
|
12.1%
4/33
|
0.00%
0/40
|
|
Investigations
Alanine amino transferase Increased
|
0.00%
0/36
|
0.00%
0/35
|
0.00%
0/35
|
0.00%
0/33
|
5.0%
2/40
|
|
Investigations
Aspartate Amino transferase increased
|
0.00%
0/36
|
0.00%
0/35
|
0.00%
0/35
|
0.00%
0/33
|
5.0%
2/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place