Trial Outcomes & Findings for A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA) (NCT NCT02373202)
NCT ID: NCT02373202
Last Updated: 2018-01-30
Results Overview
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received IMP and did not necessary have to had a causal relationship with treatment. All AEs that occurred from the first dose of the IMP administration up to 6 weeks after last dose of treatment (up to Week 58) were considered as TEAEs. SAEs were AEs 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 or a medically important event. TEAEs included both SAEs and non-SAEs.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
91 participants
Primary outcome timeframe
Baseline up to Week 58
Results posted on
2018-01-30
Participant Flow
This study was conducted at 40 centers in Japan. A total of 117 participants were screened between 23 February 2015 and 9 September 2015, 26 of whom were screen failures.
A total of 91 participants were randomized to receive monotherapy stratum (in a ratio of 1:1 to sarilumab 150 mg, once in every two weeks \[q2w\] or sarilumab 200 mg, q2w) or combination stratum (background non-methotrexate disease modifying anti-rheumatic drugs \[Non-MTX DMARDs\] along with sarilumab 150/ 200 mg q2w in 1:1 ratio).
Participant milestones
| Measure |
Sarilumab 150 mg q2w + DMARDs
Participants received sarilumab 150 mg, subcutaneous (SC) injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
30
|
31
|
|
Overall Study
COMPLETED
|
13
|
9
|
27
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
3
|
1
|
Reasons for withdrawal
| Measure |
Sarilumab 150 mg q2w + DMARDs
Participants received sarilumab 150 mg, subcutaneous (SC) injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
5
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)
Baseline characteristics by cohort
| Measure |
Sarilumab 150 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w
n=30 Participants
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w
n=31 Participants
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
55.6 years
STANDARD_DEVIATION 12.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 58Population: Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received IMP and did not necessary have to had a causal relationship with treatment. All AEs that occurred from the first dose of the IMP administration up to 6 weeks after last dose of treatment (up to Week 58) were considered as TEAEs. SAEs were AEs 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 or a medically important event. TEAEs included both SAEs and non-SAEs.
Outcome measures
| Measure |
Sarilumab 150 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w
n=30 Participants
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w
n=31 Participants
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any TEAE
|
14 participants
|
13 participants
|
25 participants
|
28 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAE
|
0 participants
|
3 participants
|
1 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 58Population: Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Criteria for potentially clinically significant vital sign abnormalities: * Systolic blood pressure (SBP) supine: \<=95 mmHg and decrease from baseline (DFB) \>=20 mmHg; \>=160 mmHg and increase from baseline (IFB) \>=20 mmHg * Diastolic blood pressure (DBP) supine: \<=45 mmHg and DFB \>=10 mmHg; \>=110 mmHg and IFB ≥10 mmHg * SBP (Orthostatic): \<=-20 mmHg * DBP (Orthostatic): \<=-10 mmHg * Heart rate (HR) supine: \<=50 beats per minute (bpm) and DFB \>=20 bpm; \>=120 bpm and IFB \>=20 bpm * Weight: \>=5% DFB; \>=5% IFB
Outcome measures
| Measure |
Sarilumab 150 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w
n=30 Participants
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w
n=31 Participants
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
SBP (supine) <=95 mmHg and DFB >=20 mmHg
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
SBP (supine) >=160 mmHg and IFB >=20 mmHg
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
DBP (supine) <=45 mmHg and DFB >=10 mmHg
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
DBP (supine) >=110 mmHg and IFB >=10 mmHg
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
SBP (orthostatic) <=-20 mmHg
|
8 participants
|
5 participants
|
5 participants
|
9 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
DBP (orthostatic) <=-10 mmHg
|
3 participants
|
3 participants
|
5 participants
|
10 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
HR (supine) <=50 bpm and DFB >= 20 bpm
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
HR (supine) >=120 bpm and IFB >=20 bpm
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
Weight >=5% DFB
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
Weight >=5% IFB
|
3 participants
|
2 participants
|
12 participants
|
7 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 58Population: Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Criteria for potentially clinically significant ECG abnormalities: * PR Interval: \>200 milliseconds (ms); \>200 ms and IFB \>=25%; \>220 ms; \>220 ms and IFB \>=25%; \>240 ms; \>240 ms and IFB \>=25% * QRS Interval: \>110 ms; \>110 ms and IFB \>=25%; \>120 ms; \>120 ms and IFB \>=25% * QT Interval: \>500 ms * QTc Bazett (QTc B): \>450 ms; \>480 ms; \>500 ms; IFB \>30 and \<=60 ms, IFB \>60 ms * QTc Fridericia (QTc F): \>450 ms; \>480 ms; \>500 ms; IFB \>30 and \<=60 ms; IFB \>60 ms
Outcome measures
| Measure |
Sarilumab 150 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w
n=30 Participants
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w
n=31 Participants
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
PR >200 ms
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
PR >200 ms and IFB >=25%
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
PR >220 ms
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
PR >220 ms and IFB >=25%
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
PR >240 ms
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
PR >240 ms and IFB >=25%
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
QRS >110 ms
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
QRS >110 ms and IFB >=25%
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
QRS >120 ms
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
QRS >120 ms and IFB >=25%
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
QT >500 ms
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
QTc B >450 ms
|
2 participants
|
1 participants
|
6 participants
|
10 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
QTc B >480 ms
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
QTc B >500 ms
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
QTc B IFB >30 and <=60 ms
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
QTc B IFB >60 ms
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
QTc F >450 ms
|
2 participants
|
1 participants
|
2 participants
|
6 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
QTc F >480 ms
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
QTc F >500 ms
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
QTc F IFB >30 and <=60 ms
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
QTc F IFB >60 ms
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 58Population: Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Criteria for potentially clinically significant abnormalities: * Hemoglobin: \<=115 g/L (Male\[M\]) or \<=95 g/L (Female\[F\]); \>=185 g/L (M) or \>=165 g/L (F); DFB \>=20 g/L * Hematocrit: \<=0.37 v/v (M) or \<=0.32 v/v (F); \>=0.55 v/v (M) or \>=0.5 v/v (F) * Red blood cells (RBC): \>=6 Tera/L * Platelets: \<50 Giga/L; \>=50 and \<100 Giga/L; \>=700 Giga/L * White blood cells (WBC): \<3.0 Giga/L (Non-Black \[NB\]) or \<2.0 Giga/L (Black \[B\]); \>=16.0 Giga/L * Neutrophils: \<1.5 Giga/L (NB) or \<1.0 Giga/L (B); \<1.0 Giga/L * Lymphocytes: \<0.5 Giga/L; \>=0.5 Giga/L and \<lower limit of normal (LLN); \>4.0 Giga/L * Monocytes: \>0.7 Giga/L * Basophils: \>0.1 Giga/L * Eosinophils: \>0.5 Giga/L or \>upper limit of normal (ULN) (if ULN \>=0.5 Giga/L)
Outcome measures
| Measure |
Sarilumab 150 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w
n=30 Participants
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w
n=31 Participants
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Hemoglobin <=115 g/L (M) or <=95 g/L (F)
|
0 participants
|
1 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Hemoglobin >=185 g/L (M) or >=165 g/L (F)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Hemoglobin DFB >=20 g/L
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Hematocrit <=0.37 v/v (M) or <=0.32 v/v (F)
|
0 participants
|
3 participants
|
2 participants
|
6 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Hematocrit >0.55 v/v (M) or >=0.5 v/v (F)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
RBC >=6 Tera/L
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Platelets <50 Giga/L
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Platelets >=50 and <100 Giga/L
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Platelets >=700 Giga/L
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
WBC <3.0 Giga/L (NB) or <2.0 Giga/L (B)
|
6 participants
|
9 participants
|
7 participants
|
9 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
WBC >=16.0 Giga/L
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Neutrophils <1.5 Giga/L (NB) or <1.0 Giga/L (B)
|
8 participants
|
11 participants
|
8 participants
|
13 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Neutrophils <1.0 Giga/L
|
5 participants
|
3 participants
|
2 participants
|
4 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Lymphocytes <0.5 Giga/L
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Lymphocytes >=0.5 Giga/L and <LLN
|
3 participants
|
4 participants
|
3 participants
|
8 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Lymphocytes >4.0 Giga/L
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Monocytes >0.7 Giga/L
|
1 participants
|
0 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Basophils >0.1 Giga/L
|
1 participants
|
0 participants
|
0 participants
|
5 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Eosinophils >0.5 Giga/L or >ULN (ULN >=0.5 Giga/L)
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 58Population: Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Criteria for potentially clinically significant abnormalities: * Glucose: \<=3.9 mmol/L and \<LLN; \>=11.1 mmol/L (unfasted \[unfas\]) or \>=7 mmol/L (fasted \[fas\]) * Hemoglobin A1c (HbA1c): \>8% * Total cholesterol: \>=6.2 mmol/L; \>=7.74 mmol/L * LDL cholesterol: \>=4.1 mmol/L; \>=4.9 mmol/L * Triglycerides: \>=4.6 mmol/L; \>=5.6 mmol/L
Outcome measures
| Measure |
Sarilumab 150 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w
n=30 Participants
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w
n=31 Participants
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters
Total Cholesterol >=6.2 mmol/L
|
6 participants
|
7 participants
|
12 participants
|
13 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters
Glucose >=11.1 mmol/L (unfas) or >=7 mmol/L (fas)
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters
Total Cholesterol >=7.74 mmol/L
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters
LDL Cholesterol >=4.1 mmol/L
|
1 participants
|
3 participants
|
6 participants
|
3 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters
LDL Cholesterol >=4.9 mmol/L
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters
Triglycerides >=4.6 mmol/L
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters
Triglycerides >=5.6 mmol/L
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters
Glucose <=3.9 mmol/L and <LLN
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters
HbA1c >8%
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 58Population: Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Criteria for potentially clinically significant abnormalities: * Sodium: \<=129 mmol/L; \>=160 mmol/L * Potassium: \<3 mmol/L; \>=5.5 mmol/L * Chloride: \<80 mmol/L; \>115 mmol/L
Outcome measures
| Measure |
Sarilumab 150 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w
n=30 Participants
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w
n=31 Participants
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes
Sodium <=129 mmol/L
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes
Sodium >=160 mmol/L
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes
Potassium <3 mmol/L
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes
Potassium >=5.5 mmol/L
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes
Chloride <80 mmol/L
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes
Chloride >115 mmol/L
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 58Population: Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Criteria for potentially clinically significant abnormalities: * Creatinine: \>=150 micromol/L (adults); \>=30% change from baseline, \>=100% change from baseline * Creatinine clearance: \<15 mL/min; \>=15 to \<30 mL/min; \>=30 to \<60 mL/min; \>=60 to \<90 mL/min * Blood urea nitrogen: \>=17 mmol/L * Uric acid: \<120 micromol/L; \>408 micromol/L
Outcome measures
| Measure |
Sarilumab 150 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w
n=30 Participants
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w
n=31 Participants
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Uric acid <120 micromol/L
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Creatinine >=150 micromol/L (Adults)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Creatinine >=30% change from baseline
|
3 participants
|
3 participants
|
6 participants
|
5 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Creatinine >=100% change from baseline
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Creatinine Clearance <15 mL/min
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Creatinine clearance >=15 to <30 mL/min
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Creatinine clearance >=30 to <60 mL/min
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Creatinine clearance >=60 to <90 mL/min
|
8 participants
|
7 participants
|
15 participants
|
17 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Blood Urea Nitrogen >=17 mmol/L
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Uric acid >408 micromol/L
|
1 participants
|
1 participants
|
2 participants
|
4 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 58Population: Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.
Criteria for potentially clinically significant abnormalities: * Alanine Aminotransferase (ALT): \>1 ULN and \<=1.5 ULN; \>1.5 ULN and \<=3 ULN; \>3 ULN and \<=5 ULN; \>5 ULN and \<=10 ULN; \>10 ULN and \<=20 ULN; \>20 ULN * Aspartate aminotransferase (AST): \>1 ULN and \<=1.5 ULN; \>1.5 ULN and \<=3 ULN; \>3 ULN and \<=5 ULN; \>5 ULN and \<=10 ULN; \>10 ULN and \<=20 ULN; \>20 ULN * Alkaline phosphatase: \>1.5 ULN * Total bilirubin (TBILI): \>1.5 ULN; \>2 ULN * Conjugated bilirubin(CBILI): \>1.5 ULN * Unconjugated bilirubin: \>1.5 ULN * ALT \>3 ULN and TBILI \>2 ULN * CBILI \>35% TBILI and TBILI \>1.5 ULN * Albumin: \<=25 g/L
Outcome measures
| Measure |
Sarilumab 150 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w
n=30 Participants
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w
n=31 Participants
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
ALT >5 ULN and <=10 ULN
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
ALT >1 ULN and <=1.5 ULN
|
3 participants
|
4 participants
|
7 participants
|
6 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
ALT >1.5 ULN and <=3 ULN
|
2 participants
|
1 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
ALT >3 ULN and <=5 ULN
|
1 participants
|
0 participants
|
1 participants
|
4 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
ALT >10 ULN and <=20 ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
ALT >20 ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
AST >1 ULN and <=1.5 ULN
|
6 participants
|
5 participants
|
8 participants
|
4 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
AST >1.5 ULN and <=3 ULN
|
1 participants
|
0 participants
|
2 participants
|
3 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
AST >3 ULN and <=5 ULN
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
AST >5 ULN and <=10 ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
AST >10 ULN and <=20 ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
AST >20 ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
Alkaline Phosphatase >1.5 ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
TBILI >1.5 ULN
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
TBILI >2 ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
CBILI >1.5 ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
Unconjugated Bilirubin >1.5 ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
ALT> 3 ULN and TBILI >2ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
CBILI >35% TBILI and TBILI >1.5 ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
Albumin <=25 g/L
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 52Population: mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures.
ACR response is a composite rating scale that includes 7 variables: tender joints count (TJC \[68 joints\]); swollen joints count (SJC \[66 joints\]); levels of an acute phase reactant (high sensitivity C-reactive protein \[hs-CRP level\]); participant's assessment of pain (measured on 0 \[no pain\]-100 mm \[worst pain\] visual analog scale \[VAS\]); participant's global assessment of disease activity (measured on 0 \[no arthritis activity\]-100 mm \[maximal arthritis activity\] VAS); physician's global assessment of disease activity (measured on 0 \[no arthritis activity\]-100 mm \[maximal arthritis activity\] VAS); participant's assessment of physical function (measured by Health Assessment Question-Disability Index \[HAQ-DI\], with scoring range of 0 \[better health\] - 3 \[worst health\]). ACR20/50/70 response is defined as at least 20/50/70% improvement in both TJC and SJC, and at least 20/50/70% improvement in at least 3 of the 5 other assessments, respectively.
Outcome measures
| Measure |
Sarilumab 150 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
n=15 Participants
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w
n=30 Participants
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w
n=31 Participants
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, 50 and 70 Responses at Week 52
ACR20
|
73.3 percentage of participants
|
40.0 percentage of participants
|
76.7 percentage of participants
|
74.2 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, 50 and 70 Responses at Week 52
ACR50
|
60.0 percentage of participants
|
33.3 percentage of participants
|
56.7 percentage of participants
|
54.8 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, 50 and 70 Responses at Week 52
ACR70
|
53.3 percentage of participants
|
26.7 percentage of participants
|
26.7 percentage of participants
|
25.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
DAS28-CRP is a composite score that contains 4 variables: TJC (based on 28 joints), SJC (based on 28 joints), participant's assessment of general health on VAS (range 0 \[very well\] to 100 mm \[extremely bad\]) and CRP (mg/L). DAS28-CRP total score ranges from 2-10 with a lower score indicating less disease activity. A DAS28-CRP above 5.1 indicates high disease activity, whereas below 3.2 indicates low disease activity and below 2.6 as disease remission.
Outcome measures
| Measure |
Sarilumab 150 mg q2w + DMARDs
n=14 Participants
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
n=10 Participants
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w
n=28 Participants
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w
n=30 Participants
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline at Week 52 in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP)
|
-2.90 units on a scale
Standard Deviation 1.06
|
-2.47 units on a scale
Standard Deviation 0.84
|
-2.62 units on a scale
Standard Deviation 1.12
|
-2.64 units on a scale
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each items's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Outcome measures
| Measure |
Sarilumab 150 mg q2w + DMARDs
n=14 Participants
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
n=10 Participants
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w
n=28 Participants
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w
n=30 Participants
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52
|
-0.52 units on a scale
Standard Deviation 0.45
|
-0.34 units on a scale
Standard Deviation 0.60
|
-0.48 units on a scale
Standard Deviation 0.58
|
-0.38 units on a scale
Standard Deviation 0.34
|
Adverse Events
Sarilumab 150 mg q2w + DMARDs
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Sarilumab 200 mg q2w + DMARDs
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Sarilumab 150 mg q2w Monotherapy
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Sarilumab 200 mg q2w Monotherapy
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sarilumab 150 mg q2w + DMARDs
n=15 participants at risk
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
n=15 participants at risk
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w Monotherapy
n=30 participants at risk
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w Monotherapy
n=31 participants at risk
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Infections and infestations
Herpes zoster oticus
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Infections and infestations
Periorbital abscess
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.2%
1/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.2%
1/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
Other adverse events
| Measure |
Sarilumab 150 mg q2w + DMARDs
n=15 participants at risk
Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 200 mg q2w + DMARDs
n=15 participants at risk
Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.
|
Sarilumab 150 mg q2w Monotherapy
n=30 participants at risk
Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.
|
Sarilumab 200 mg q2w Monotherapy
n=31 participants at risk
Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
5/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
20.0%
3/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
9.7%
3/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.2%
1/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.5%
2/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.5%
2/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.2%
1/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
2/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Gastrointestinal disorders
Glossodynia
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
3/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
26.7%
4/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
10.0%
3/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
12.9%
4/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
General disorders
Injection site erythema
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
19.4%
6/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
General disorders
Injection site haemorrhage
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
General disorders
Injection site pruritus
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.2%
1/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
General disorders
Injection site rash
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
General disorders
Injection site swelling
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.5%
2/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
General disorders
Oedema peripheral
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
12.9%
4/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Infections and infestations
Conjunctivitis
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Infections and infestations
Enteritis infectious
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Infections and infestations
Gastroenteritis
|
13.3%
2/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.2%
1/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Infections and infestations
Gingivitis
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Infections and infestations
Nasopharyngitis
|
26.7%
4/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
33.3%
5/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
43.3%
13/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
45.2%
14/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Infections and infestations
Periodontitis
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
2/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
3/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
2/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Injury, poisoning and procedural complications
Heat stroke
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.2%
1/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Investigations
Neutrophil count decreased
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
2/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.2%
1/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Investigations
Protein urine
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Investigations
Weight increased
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Investigations
White blood cell count decreased
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.2%
1/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.5%
2/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
13.3%
4/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.5%
2/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
13.3%
2/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
2/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.2%
1/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Nervous system disorders
Sciatica
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.2%
1/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Renal and urinary disorders
Renal impairment
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.2%
1/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
2/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
10.0%
3/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.5%
2/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.5%
2/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
2/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.2%
1/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.5%
2/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.2%
1/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
0.00%
0/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
6.7%
1/15 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.3%
1/30 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
3.2%
1/31 • All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \[up to Week 58\]).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER