Trial Outcomes & Findings for A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients (NCT NCT01426789)
NCT ID: NCT01426789
Last Updated: 2015-08-10
Results Overview
A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
12 weeks
Results posted on
2015-08-10
Participant Flow
The study included a 12 week, randomized, double blind phase (part 1), a 40 week, open label phase (part 2), and a 3 month safety follow-up. Participants from the secukinumab arm, who completed part 1 and had an ACR50 or greater response at week 12, and participants from the placebo arm, who completed part 1, were eligible for the open label phase.
One hundred participants received study treatment in part 1. Ten participants discontinued during part 1. At the end of part 1, 76 participants were eligible to take secukinumab treatment in part 2.
Participant milestones
| Measure |
Secukinumab
10 mg/kg intravenous (I.V.)
|
Placebo
Placebo i.v.
|
Group 1
Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly
|
Group 2
Part 1: secukinumab 6 x 10 mg/kg i.v.; part 2: no study treatment
|
Group 3
Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly
|
Group 4
Part 1: placebo; Part 2: no study treatment
|
|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
68
|
32
|
0
|
0
|
0
|
0
|
|
Part 1
COMPLETED
|
62
|
28
|
0
|
0
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
6
|
4
|
0
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
49
|
13
|
27
|
1
|
|
Part 2
COMPLETED
|
0
|
0
|
34
|
12
|
19
|
1
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
15
|
1
|
8
|
0
|
Reasons for withdrawal
| Measure |
Secukinumab
10 mg/kg intravenous (I.V.)
|
Placebo
Placebo i.v.
|
Group 1
Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly
|
Group 2
Part 1: secukinumab 6 x 10 mg/kg i.v.; part 2: no study treatment
|
Group 3
Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly
|
Group 4
Part 1: placebo; Part 2: no study treatment
|
|---|---|---|---|---|---|---|
|
Part 1
Protocol deviation
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 1
Lost to Follow-up
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Part 1
Lack of Efficacy
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Part 1
Adverse Event
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
Protocol deviation
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 2
Death
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Part 2
Administrative problems
|
0
|
0
|
2
|
0
|
1
|
0
|
|
Part 2
Lost to Follow-up
|
0
|
0
|
4
|
0
|
1
|
0
|
|
Part 2
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
2
|
0
|
|
Part 2
Lack of Efficacy
|
0
|
0
|
5
|
0
|
2
|
0
|
|
Part 2
Adverse Event
|
0
|
0
|
2
|
0
|
1
|
0
|
Baseline Characteristics
A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients
Baseline characteristics by cohort
| Measure |
Secukinumab
n=68 Participants
10 mg/kg intravenous (I.V.)
|
Placebo
n=32 Participants
Placebo i.v.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 Years
STANDARD_DEVIATION 11.45 • n=5 Participants
|
54.5 Years
STANDARD_DEVIATION 10.30 • n=7 Participants
|
51.1 Years
STANDARD_DEVIATION 11.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Participants, who completed part 1, were included in the analysis.
A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).
Outcome measures
| Measure |
Secukinumab
n=62 Participants
10 mg/kg intravenous (I.V.)
|
Placebo
n=28 Participants
Placebo i.v.
|
|---|---|---|
|
Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20 ) in Association With the Presence or Absence of the HLA-DRB1 *4 Allelic Group
HLADRB1 *04 carriers
|
45.2 Percentage of participants
|
10.7 Percentage of participants
|
|
Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20 ) in Association With the Presence or Absence of the HLA-DRB1 *4 Allelic Group
HLADRB1 *04 non-carriers
|
41.9 Percentage of participants
|
14.3 Percentage of participants
|
PRIMARY outcome
Timeframe: baseline, 12 weeksPopulation: Participants, who completed part 1, were included in the analysis.
The DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the tender joint count(TJC) and swollen joint count (SJC) out of a total of 28 joints, the high-sensitivity C-reactive protein (hsCRP), and the subject's 'global assessment' of disease activity/general health (GH). The subject's global assessment/GH was indicated by a visual analogue scale of 100 mm where the participant marked a point on a 100 mm line between 0 and 100 (0 indicated very good and 100 indicated very bad). The following formula was used to calculate DAS28: DAS-CRP = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) = 0.36\*ln(CRP+1) + 0.014\*GH = 0.96. A DAS28-CRP score \> 5.1 implies active disease, \<3.2 implies controlled disease and \<2.6 implied remission. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Secukinumab
n=62 Participants
10 mg/kg intravenous (I.V.)
|
Placebo
n=28 Participants
Placebo i.v.
|
|---|---|---|
|
Change From Baseline in Disease Activity Score 28 (DAS28) in Association With the Presence or Absence of HLA-DRB1 04
HLA-DRB1 *04 carriers
|
-2.5 score on a scale
Standard Error 0.5273
|
-0.6 score on a scale
Standard Error 0.5750
|
|
Change From Baseline in Disease Activity Score 28 (DAS28) in Association With the Presence or Absence of HLA-DRB1 04
HLA-DRB1 *04 non-carriers
|
-2.2 score on a scale
Standard Error 0.5618
|
-0.8 score on a scale
Standard Error 0.6098
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants, who completed part 1, were included in the analysis.
A participant was considered to be a responder according to the ACR50 or ACR70 criteria if the participant had at least 50% or 70% improvement, respectively, in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).
Outcome measures
| Measure |
Secukinumab
n=62 Participants
10 mg/kg intravenous (I.V.)
|
Placebo
n=28 Participants
Placebo i.v.
|
|---|---|---|
|
Percentage of Participants Who Achieve ACR50 and ACR70 With the Presence/Absence of the HLA-DRB1*04 Allelic Group
ACR50: HLADRB1 *04 presence
|
38.7 Percentage of participants
|
7.1 Percentage of participants
|
|
Percentage of Participants Who Achieve ACR50 and ACR70 With the Presence/Absence of the HLA-DRB1*04 Allelic Group
ACR50: HLADRB1 *04 absence
|
35.5 Percentage of participants
|
10.7 Percentage of participants
|
|
Percentage of Participants Who Achieve ACR50 and ACR70 With the Presence/Absence of the HLA-DRB1*04 Allelic Group
ACR70: HLADRB1 *04 presence
|
8.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Who Achieve ACR50 and ACR70 With the Presence/Absence of the HLA-DRB1*04 Allelic Group
ACR70: HLADRB1 *04 absence
|
8.1 Percentage of participants
|
7.1 Percentage of participants
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Participants, who completed part 1, were included in the analysis. Statistical analysis was not done on the other biomarkers: osteoprotegerin (OPG), rheumatoid factor (RF), anti-cyclic citrullinated peptide antibodies (CCP) and hsCRP. Therefore, data is provided for the alleles only.
The DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the tender joint count(TJC) and swollen joint count (SJC) out of a total of 28 joints, the high-sensitivity C-reactive protein (hsCRP), and the subject's 'global assessment' of disease activity/general health (GH). The subject's global assessment/GH was indicated by a visual analogue scale of 100 mm where the participant marked a point on a 100 mm line between 0 and 100 (0 indicated very good and 100 indicated very bad). The following formula was used to calculate DAS28: DAS-CRP = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) = 0.36\*ln(CRP+1) + 0.014\*GH = 0.96. A DAS28-CRP score \> 5.1 implies active disease, \<3.2 implies controlled disease and \<2.6 implied remission. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Secukinumab
n=62 Participants
10 mg/kg intravenous (I.V.)
|
Placebo
n=28 Participants
Placebo i.v.
|
|---|---|---|
|
Change From Baseline in DAS28 in Association With the Presence or Absence of HLA-DRB1 *SE (Positive), HLA-DRB1 *401 (Carrier) and HLA-DRB1 Position 11 V/L and in Association With Other Biomarkers
HLA-DRB1 *SE carrier
|
-2.6 score on a scale
Standard Error 0.5049
|
-0.5 score on a scale
Standard Error 05240
|
|
Change From Baseline in DAS28 in Association With the Presence or Absence of HLA-DRB1 *SE (Positive), HLA-DRB1 *401 (Carrier) and HLA-DRB1 Position 11 V/L and in Association With Other Biomarkers
HLA-DRB1 *SE non-carrier
|
-2.3 score on a scale
Standard Error 0.5376
|
-2.2 score on a scale
Standard Error 0.6977
|
|
Change From Baseline in DAS28 in Association With the Presence or Absence of HLA-DRB1 *SE (Positive), HLA-DRB1 *401 (Carrier) and HLA-DRB1 Position 11 V/L and in Association With Other Biomarkers
HLA-DRB1 *0401 carrier
|
-2.4 score on a scale
Standard Error 0.5922
|
0.1 score on a scale
Standard Error 0.7503
|
|
Change From Baseline in DAS28 in Association With the Presence or Absence of HLA-DRB1 *SE (Positive), HLA-DRB1 *401 (Carrier) and HLA-DRB1 Position 11 V/L and in Association With Other Biomarkers
HLA-DRB1 *401 non-carrier
|
-2.3 score on a scale
Standard Error 0.5133
|
-0.9 score on a scale
Standard Error 0.5456
|
|
Change From Baseline in DAS28 in Association With the Presence or Absence of HLA-DRB1 *SE (Positive), HLA-DRB1 *401 (Carrier) and HLA-DRB1 Position 11 V/L and in Association With Other Biomarkers
HLA-DRB1 position 11 V/L carrier
|
-2.5 score on a scale
Standard Error 0.4901
|
-0.4 score on a scale
Standard Error 0.5218
|
|
Change From Baseline in DAS28 in Association With the Presence or Absence of HLA-DRB1 *SE (Positive), HLA-DRB1 *401 (Carrier) and HLA-DRB1 Position 11 V/L and in Association With Other Biomarkers
HLA-DRB1 position 11 V/L non-carrier
|
-2.2 score on a scale
Standard Error 0.5706
|
-2.2 score on a scale
Standard Error 0.6954
|
Adverse Events
Secukinumab
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 1
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 3
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Secukinumab
n=68 participants at risk
10mg/kg i.v.
|
Placebo
n=32 participants at risk
Placebo i.v.
|
Group 1
n=49 participants at risk
Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly
|
Group 3
n=27 participants at risk
Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
2.0%
1/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
2.0%
1/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.1%
1/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
General disorders
Multi-organ failure
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
2.0%
1/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.1%
1/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Infections and infestations
Osteomyelitis
|
1.5%
1/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
2.0%
1/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
2.0%
1/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
2.0%
1/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
1.5%
1/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
2.0%
1/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.1%
1/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
1.5%
1/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
2.0%
1/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Vascular disorders
Vasculitis necrotising
|
1.5%
1/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
Other adverse events
| Measure |
Secukinumab
n=68 participants at risk
10mg/kg i.v.
|
Placebo
n=32 participants at risk
Placebo i.v.
|
Group 1
n=49 participants at risk
Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly
|
Group 3
n=27 participants at risk
Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.5%
1/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
4.1%
2/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Infections and infestations
Otitis media
|
1.5%
1/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Eye disorders
Dry eye
|
1.5%
1/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.1%
1/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.4%
3/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.1%
1/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
2.0%
1/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.1%
1/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.1%
1/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.1%
1/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
General disorders
Chest pain
|
1.5%
1/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
General disorders
Injection site erythema
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
General disorders
Injection site haematoma
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.1%
1/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
General disorders
Injection site induration
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
General disorders
Oedema peripheral
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Infections and infestations
Bronchitis
|
1.5%
1/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
4.1%
2/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Infections and infestations
Influenza
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
6.1%
3/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
6.2%
2/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
2.0%
1/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
4.1%
2/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Infections and infestations
Tonsillitis
|
1.5%
1/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
2.0%
1/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
3/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.1%
1/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
2.0%
1/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
1/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
1/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
7.4%
2/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Investigations
Aspartate aminotransferase increased
|
1.5%
1/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
7.4%
2/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Investigations
Blood pressure increased
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
2.0%
1/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
2.0%
1/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.5%
1/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
6.2%
2/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
14.3%
7/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
2.0%
1/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.9%
2/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.1%
1/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
4.1%
2/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/68
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/32
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
0.00%
0/49
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
3.7%
1/27
Adverse events that occurred in subjects after they discontinued during or at the end of Part 1 are not included in the Part 2 safety analysis. Therefore, treatment groups from Part 1 and groups 1 and 3 from Part 2 are presented only.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER