Trial Outcomes & Findings for 4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis (NCT NCT01640951)

Last Updated: 2018-05-25

Results Overview

Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

675 participants

Primary outcome timeframe

Week 268

Results posted on

2018-05-25

Participant Flow

675 subjects from the core studies (CAIN457A2304 and CAIN457A2307) were enrolled at 112 sites. Subjects enrolled in the secukinumab 300 mg Open-Label (OL) arm came only from the CAIN457A2307 study, as such they were partial responders at Week 12, while all other subjects in the extension were PASI 75 responders at Week 12 in the core study.

At Week 156, subjects who rolled over from the CAIN457A2304 study were unblinded and provided an option to switch to one of the treatment options described below upon investigator judgment; subjects from the CAIN457A2307 study could administer study drug at home every 4 weeks, but were required to come for office visits every 12-16 weeks.

Participant milestones

Participant milestones
Measure	AIN150FI AIN457 150 mg - Fixed Interval (FI)	AIN150 FI_AIN300 FI AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)	AIN300 FI AIN457 300 mg - Fixed Interval (FI)	AIN150 SoR AIN457 150 mg - Start of Relapse (SoR)	AIN150 SOR_AIN300 FI AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)	AIN300 SoR AIN457 300 mg - Start of Relapse (SoR)	AIN300 SoR _ AIN300 FI AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)	AIN300 OL AIN457 300 mg Open-label (OL)
Overall Study STARTED	77	75	168	55	95	60	112	33
Overall Study COMPLETED	31	60	126	10	82	13	94	17
Overall Study NOT COMPLETED	46	15	42	45	13	47	18	16

Reasons for withdrawal

Reasons for withdrawal
Measure	AIN150FI AIN457 150 mg - Fixed Interval (FI)	AIN150 FI_AIN300 FI AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)	AIN300 FI AIN457 300 mg - Fixed Interval (FI)	AIN150 SoR AIN457 150 mg - Start of Relapse (SoR)	AIN150 SOR_AIN300 FI AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)	AIN300 SoR AIN457 300 mg - Start of Relapse (SoR)	AIN300 SoR _ AIN300 FI AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)	AIN300 OL AIN457 300 mg Open-label (OL)
Overall Study Adverse Event	8	3	10	6	1	11	1	3
Overall Study Lack of Efficacy	20	1	7	14	0	6	5	6
Overall Study Lost to Follow-up	1	0	6	2	2	3	1	1
Overall Study Non-compliance with study treatment	0	0	1	1	1	4	1	0
Overall Study Physician Decision	2	5	2	2	2	3	3	0
Overall Study Pregnancy	3	0	0	4	0	0	2	0
Overall Study Protocol Deviation	0	1	2	1	0	1	0	0
Overall Study Subject/Guardian decision	12	4	13	15	7	19	5	4
Overall Study Death	0	1	1	0	0	0	0	2

Baseline Characteristics

4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AIN150FI n=77 Participants AIN457 150 mg - Fixed Interval (FI)	AIN150 FI_AIN300 FI n=75 Participants AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)	AIN300 FI n=168 Participants AIN457 300 mg - Fixed Interval (FI)	AIN150 SoR n=55 Participants AIN457 150 mg - Start of Relapse (SoR)	AIN150 SOR_AIN300 FI n=95 Participants AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)	AIN300 SoR n=60 Participants AIN457 300 mg - Start of Relapse (SoR)	AIN300 SoR _ AIN300 FI n=112 Participants AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)	AIN300 OL n=33 Participants AIN457 300 mg Open-label (OL)	Total n=675 Participants Total of all reporting groups
Age, Continuous	42.3 Years STANDARD_DEVIATION 13.24 • n=5 Participants	46.0 Years STANDARD_DEVIATION 12.03 • n=7 Participants	48.5 Years STANDARD_DEVIATION 12.54 • n=5 Participants	42.7 Years STANDARD_DEVIATION 12.23 • n=4 Participants	48.0 Years STANDARD_DEVIATION 12.13 • n=21 Participants	45.2 Years STANDARD_DEVIATION 12.08 • n=8 Participants	44.6 Years STANDARD_DEVIATION 13.09 • n=8 Participants	46.5 Years STANDARD_DEVIATION 13.99 • n=24 Participants	45.9 Years STANDARD_DEVIATION 12.74 • n=42 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants	25 Participants n=4 Participants	28 Participants n=21 Participants	18 Participants n=8 Participants	35 Participants n=8 Participants	12 Participants n=24 Participants	231 Participants n=42 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	50 Participants n=7 Participants	118 Participants n=5 Participants	30 Participants n=4 Participants	67 Participants n=21 Participants	42 Participants n=8 Participants	77 Participants n=8 Participants	21 Participants n=24 Participants	444 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants	5 Participants n=4 Participants	21 Participants n=21 Participants	9 Participants n=8 Participants	26 Participants n=8 Participants	4 Participants n=24 Participants	123 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	12 Participants n=42 Participants
Race (NIH/OMB) White	62 Participants n=5 Participants	60 Participants n=7 Participants	132 Participants n=5 Participants	48 Participants n=4 Participants	68 Participants n=21 Participants	45 Participants n=8 Participants	84 Participants n=8 Participants	29 Participants n=24 Participants	528 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	9 Participants n=42 Participants

PRIMARY outcome

Timeframe: Week 268

Population: Safety Set. All subjects who took at least one dose of study treatment during the extension treatment period. A subject with multiple adverse events within a primary system organ class was counted only once in the total row. Deaths up to 28 days after the last dose are included. Only descriptive analysis done.

Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)

Outcome measures

Outcome measures
Measure	AIN150FI n=77 Participants AIN457 150 mg - Fixed Interval (FI)	AIN150 FI_AIN300 FI n=75 Participants AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)	AIN300 FI n=168 Participants AIN457 300 mg - Fixed Interval (FI)	AIN150 SoR n=55 Participants AIN457 150 mg - Start of Relapse (SoR)	AIN150 SOR_AIN300 FI n=95 Participants AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)	AIN300 SoR n=60 Participants AIN457 300 mg - Start of Relapse (SoR)	AIN300 SoR _ AIN300 FI n=112 Participants AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)	AIN300 OL n=33 Participants AIN457 300 mg Open-label (OL)	AIN300 OL AIN457 300 mg Open-label (OL)
Long-term Safety and Tolerability of Secukinumab AEs by Primary System Organ Class (SOC)	88.3 Percentage of participants	92.0 Percentage of participants	92.9 Percentage of participants	78.2 Percentage of participants	87.4 Percentage of participants	80.0 Percentage of participants	94.6 Percentage of participants	93.9 Percentage of participants	—
Long-term Safety and Tolerability of Secukinumab SAEs by Primary System Organ Class (SOC)	20.8 Percentage of participants	24.0 Percentage of participants	23.8 Percentage of participants	16.4 Percentage of participants	20.0 Percentage of participants	18.3 Percentage of participants	17.0 Percentage of participants	36.4 Percentage of participants	—
Long-term Safety and Tolerability of Secukinumab Deaths by Primary System Organ Class (SOC)	0.0 Percentage of participants	1.3 Percentage of participants	0.6 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	6.1 Percentage of participants	—

SECONDARY outcome

Timeframe: Week 52, Week 104, Week 156, Week 208, Week 260

Population: The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.

PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)

Outcome measures

Outcome measures
Measure	AIN150FI n=77 Participants AIN457 150 mg - Fixed Interval (FI)	AIN150 FI_AIN300 FI n=75 Participants AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)	AIN300 FI n=152 Participants AIN457 300 mg - Fixed Interval (FI)	AIN150 SoR n=168 Participants AIN457 150 mg - Start of Relapse (SoR)	AIN150 SOR_AIN300 FI n=55 Participants AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)	AIN300 SoR n=95 Participants AIN457 300 mg - Start of Relapse (SoR)	AIN300 SoR _ AIN300 FI n=60 Participants AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)	AIN300 OL n=112 Participants AIN457 300 mg Open-label (OL)	AIN300 OL n=33 Participants AIN457 300 mg Open-label (OL)
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260 Week 52	69.7 Percentage of Participants	65.3 Percentage of Participants	67.5 Percentage of Participants	88.9 Percentage of Participants	38.2 Percentage of Participants	38.9 Percentage of Participants	51.7 Percentage of Participants	39.6 Percentage of Participants	63.6 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260 Week 104	63.3 Percentage of Participants	54.8 Percentage of Participants	58.6 Percentage of Participants	80.9 Percentage of Participants	40.0 Percentage of Participants	39.4 Percentage of Participants	55.9 Percentage of Participants	44.5 Percentage of Participants	63.3 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260 Week 156	85.0 Percentage of Participants	49.3 Percentage of Participants	61.7 Percentage of Participants	78.4 Percentage of Participants	62.5 Percentage of Participants	35.1 Percentage of Participants	65.0 Percentage of Participants	41.4 Percentage of Participants	57.1 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260 Week 208	80.0 Percentage of Participants	78.3 Percentage of Participants	78.8 Percentage of Participants	87.9 Percentage of Participants	63.6 Percentage of Participants	87.4 Percentage of Participants	41.7 Percentage of Participants	79.0 Percentage of Participants	61.9 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260 Week 260	89.7 Percentage of Participants	71.4 Percentage of Participants	77.6 Percentage of Participants	88.5 Percentage of Participants	50.0 Percentage of Participants	86.1 Percentage of Participants	53.8 Percentage of Participants	81.6 Percentage of Participants	75.0 Percentage of Participants

SECONDARY outcome

Timeframe: Week 52, Week 104, Week 156, Week 208, Week 260

Outcome measures

Outcome measures
Measure	AIN150FI n=77 Participants AIN457 150 mg - Fixed Interval (FI)	AIN150 FI_AIN300 FI n=75 Participants AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)	AIN300 FI n=152 Participants AIN457 300 mg - Fixed Interval (FI)	AIN150 SoR n=168 Participants AIN457 150 mg - Start of Relapse (SoR)	AIN150 SOR_AIN300 FI n=55 Participants AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)	AIN300 SoR n=95 Participants AIN457 300 mg - Start of Relapse (SoR)	AIN300 SoR _ AIN300 FI n=60 Participants AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)	AIN300 OL n=112 Participants AIN457 300 mg Open-label (OL)	AIN300 OL n=33 Participants AIN457 300 mg Open-label (OL)
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 Week 52 / PASI 100	31.6 Percentage of Participants	16.0 Percentage of Participants	23.8 Percentage of Participants	43.8 Percentage of Participants	3.6 Percentage of Participants	2.1 Percentage of Participants	8.6 Percentage of Participants	3.6 Percentage of Participants	9.1 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 Week 52 / PASI 50	89.5 Percentage of Participants	98.7 Percentage of Participants	94.0 Percentage of Participants	98.8 Percentage of Participants	80.0 Percentage of Participants	86.3 Percentage of Participants	91.4 Percentage of Participants	88.3 Percentage of Participants	93.9 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 Week 52 / PASI 90	61.8 Percentage of Participants	38.7 Percentage of Participants	50.3 Percentage of Participants	68.5 Percentage of Participants	12.7 Percentage of Participants	11.6 Percentage of Participants	19.0 Percentage of Participants	12.6 Percentage of Participants	39.4 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 Week 104 / PASI 50	88.3 Percentage of Participants	84.9 Percentage of Participants	86.5 Percentage of Participants	96.7 Percentage of Participants	80.0 Percentage of Participants	87.2 Percentage of Participants	88.2 Percentage of Participants	85.5 Percentage of Participants	86.7 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 Week 104 / PASI 90	46.7 Percentage of Participants	23.3 Percentage of Participants	33.8 Percentage of Participants	64.5 Percentage of Participants	16.7 Percentage of Participants	9.6 Percentage of Participants	14.7 Percentage of Participants	18.2 Percentage of Participants	26.7 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 Week 104 / PASI 100	28.3 Percentage of Participants	6.8 Percentage of Participants	16.5 Percentage of Participants	43.4 Percentage of Participants	10.0 Percentage of Participants	1.1 Percentage of Participants	5.9 Percentage of Participants	4.5 Percentage of Participants	13.3 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 Week 156 / PASI 50	100.0 Percentage of Participants	86.7 Percentage of Participants	91.3 Percentage of Participants	97.1 Percentage of Participants	93.8 Percentage of Participants	88.3 Percentage of Participants	85.0 Percentage of Participants	90.1 Percentage of Participants	90.5 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 Week 156 / PASI 90	60.0 Percentage of Participants	17.3 Percentage of Participants	32.2 Percentage of Participants	61.9 Percentage of Participants	31.3 Percentage of Participants	10.6 Percentage of Participants	30.0 Percentage of Participants	10.8 Percentage of Participants	28.6 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 Week 156 / PASI 100	45.0 Percentage of Participants	8.0 Percentage of Participants	20.9 Percentage of Participants	41.7 Percentage of Participants	6.3 Percentage of Participants	4.3 Percentage of Participants	0.0 Percentage of Participants	3.6 Percentage of Participants	19.0 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 Week 208 / PASI 50	100.0 Percentage of Participants	97.1 Percentage of Participants	98.1 Percentage of Participants	97.0 Percentage of Participants	72.7 Percentage of Participants	98.9 Percentage of Participants	100.0 Percentage of Participants	95.0 Percentage of Participants	95.2 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 Week 260 / PASI 90	51.7 Percentage of Participants	46.4 Percentage of Participants	48.2 Percentage of Participants	66.4 Percentage of Participants	30.0 Percentage of Participants	57.0 Percentage of Participants	7.7 Percentage of Participants	54.0 Percentage of Participants	43.8 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 Week 208 / PASI 90	51.4 Percentage of Participants	49.3 Percentage of Participants	50.0 Percentage of Participants	65.9 Percentage of Participants	27.3 Percentage of Participants	64.4 Percentage of Participants	16.7 Percentage of Participants	53.0 Percentage of Participants	23.8 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 Week 208 / PASI 100	28.6 Percentage of Participants	20.3 Percentage of Participants	23.1 Percentage of Participants	43.2 Percentage of Participants	9.1 Percentage of Participants	23.0 Percentage of Participants	0.0 Percentage of Participants	24.0 Percentage of Participants	23.8 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 Week 260 / PASI 50	100.0 Percentage of Participants	96.4 Percentage of Participants	97.6 Percentage of Participants	97.5 Percentage of Participants	100.0 Percentage of Participants	97.5 Percentage of Participants	100.0 Percentage of Participants	93.1 Percentage of Participants	87.5 Percentage of Participants
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260 Week 260 / PASI 100	31.0 Percentage of Participants	17.9 Percentage of Participants	22.4 Percentage of Participants	41.0 Percentage of Participants	10.0 Percentage of Participants	29.1 Percentage of Participants	7.7 Percentage of Participants	18.4 Percentage of Participants	25.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 52, Week 104, Week 156, Week 208, Week 260

Outcome measures

Outcome measures
Measure	AIN150FI n=77 Participants AIN457 150 mg - Fixed Interval (FI)	AIN150 FI_AIN300 FI n=75 Participants AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)	AIN300 FI n=152 Participants AIN457 300 mg - Fixed Interval (FI)	AIN150 SoR n=168 Participants AIN457 150 mg - Start of Relapse (SoR)	AIN150 SOR_AIN300 FI n=55 Participants AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)	AIN300 SoR n=95 Participants AIN457 300 mg - Start of Relapse (SoR)	AIN300 SoR _ AIN300 FI n=60 Participants AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)	AIN300 OL n=112 Participants AIN457 300 mg Open-label (OL)	AIN300 OL n=33 Participants AIN457 300 mg Open-label (OL)
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260 Week 156	-90.27 Percent change Standard Deviation 11.543	-71.48 Percent change Standard Deviation 19.892	-78.02 Percent change Standard Deviation 19.576	-88.34 Percent change Standard Deviation 15.555	-78.97 Percent change Standard Deviation 16.709	-68.71 Percent change Standard Deviation 18.094	-77.40 Percent change Standard Deviation 18.714	-69.77 Percent change Standard Deviation 18.586	-76.12 Percent change Standard Deviation 20.437
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260 Week 52	-83.54 Percent change Standard Deviation 21.744	-81.47 Percent change Standard Deviation 16.179	-82.51 Percent change Standard Deviation 19.147	-91.14 Percent change Standard Deviation 13.377	-65.13 Percent change Standard Deviation 23.452	-67.91 Percent change Standard Deviation 21.521	-75.63 Percent change Standard Deviation 16.970	-69.13 Percent change Standard Deviation 18.976	-79.75 Percent change Standard Deviation 17.045
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260 Week 104	-78.13 Percent change Standard Deviation 26.278	-72.47 Percent change Standard Deviation 24.099	-75.02 Percent change Standard Deviation 25.168	-88.48 Percent change Standard Deviation 16.273	-63.17 Percent change Standard Deviation 28.596	-68.40 Percent change Standard Deviation 18.057	-67.62 Percent change Standard Deviation 40.039	-70.98 Percent change Standard Deviation 19.720	-76.10 Percent change Standard Deviation 19.342
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260 Week 208	-87.60 Percent change Standard Deviation 12.296	-85.06 Percent change Standard Deviation 14.082	-85.91 Percent change Standard Deviation 13.501	-90.46 Percent change Standard Deviation 14.116	-72.64 Percent change Standard Deviation 24.394	-89.36 Percent change Standard Deviation 12.978	-74.38 Percent change Standard Deviation 13.817	-85.25 Percent change Standard Deviation 17.018	-79.12 Percent change Standard Deviation 16.827
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260 Week 260	-88.75 Percent change Standard Deviation 10.928	-84.10 Percent change Standard Deviation 15.012	-85.68 Percent change Standard Deviation 13.867	-90.06 Percent change Standard Deviation 14.639	-76.20 Percent change Standard Deviation 17.418	-89.40 Percent change Standard Deviation 12.763	-78.13 Percent change Standard Deviation 10.197	-85.48 Percent change Standard Deviation 17.116	-81.47 Percent change Standard Deviation 21.335

SECONDARY outcome

Timeframe: Week 52, Week 104, Week 156, Week 208, Week 260

The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe). The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe.

Outcome measures

Outcome measures
Measure	AIN150FI n=77 Participants AIN457 150 mg - Fixed Interval (FI)	AIN150 FI_AIN300 FI n=75 Participants AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)	AIN300 FI n=152 Participants AIN457 300 mg - Fixed Interval (FI)	AIN150 SoR n=168 Participants AIN457 150 mg - Start of Relapse (SoR)	AIN150 SOR_AIN300 FI n=55 Participants AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)	AIN300 SoR n=95 Participants AIN457 300 mg - Start of Relapse (SoR)	AIN300 SoR _ AIN300 FI n=60 Participants AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)	AIN300 OL n=112 Participants AIN457 300 mg Open-label (OL)	AIN300 OL n=33 Participants AIN457 300 mg Open-label (OL)
Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260 Week 52 / IGA 0/1	59.2 Percentage of Participants	50.7 Percentage of Participants	55.0 Percentage of Participants	69.1 Percentage of Participants	20.0 Percentage of Participants	20.0 Percentage of Participants	28.3 Percentage of Participants	19.8 Percentage of Participants	42.4 Percentage of Participants
Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260 Week 104 / IGA 0/1	51.7 Percentage of Participants	30.1 Percentage of Participants	39.8 Percentage of Participants	66.4 Percentage of Participants	20.0 Percentage of Participants	16.0 Percentage of Participants	17.6 Percentage of Participants	17.3 Percentage of Participants	23.3 Percentage of Participants
Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260 Week 156 / IGA 0/1	62.5 Percentage of Participants	21.3 Percentage of Participants	35.7 Percentage of Participants	56.8 Percentage of Participants	37.5 Percentage of Participants	14.9 Percentage of Participants	25.0 Percentage of Participants	15.3 Percentage of Participants	28.6 Percentage of Participants
Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260 Week 208 / IGA 0/1	57.1 Percentage of Participants	47.1 Percentage of Participants	50.5 Percentage of Participants	62.1 Percentage of Participants	41.7 Percentage of Participants	63.2 Percentage of Participants	8.3 Percentage of Participants	52.0 Percentage of Participants	23.8 Percentage of Participants
Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260 Week 260 / IGA 0/1	55.2 Percentage of Participants	48.2 Percentage of Participants	50.6 Percentage of Participants	65.0 Percentage of Participants	40.0 Percentage of Participants	58.2 Percentage of Participants	30.8 Percentage of Participants	54.0 Percentage of Participants	37.5 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 52, Week 104, Week 156, Week 208, Week 260

The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions

Outcome measures

Outcome measures
Measure	AIN150FI n=77 Participants AIN457 150 mg - Fixed Interval (FI)	AIN150 FI_AIN300 FI n=75 Participants AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)	AIN300 FI n=152 Participants AIN457 300 mg - Fixed Interval (FI)	AIN150 SoR n=168 Participants AIN457 150 mg - Start of Relapse (SoR)	AIN150 SOR_AIN300 FI n=55 Participants AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)	AIN300 SoR n=95 Participants AIN457 300 mg - Start of Relapse (SoR)	AIN300 SoR _ AIN300 FI n=60 Participants AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)	AIN300 OL n=112 Participants AIN457 300 mg Open-label (OL)	AIN300 OL n=33 Participants AIN457 300 mg Open-label (OL)
Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260 Week 52	-77.3 Percent change Interval -87.5 to -68.3	-85.7 Percent change Interval -90.0 to -77.8	-81.8 Percent change Interval -87.5 to -75.0	-93.3 Percent change Interval -95.5 to -90.3	-65.0 Percent change Interval -74.7 to -55.6	-68.2 Percent change Interval -75.0 to -61.0	-66.7 Percent change Interval -75.0 to -52.9	-72.8 Percent change Interval -79.0 to -65.0	-79.2 Percent change Interval -89.6 to -65.0
Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260 Week 104	-70.8 Percent change Interval -83.3 to -63.3	-73.8 Percent change Interval -80.4 to -65.9	-73.3 Percent change Interval -78.1 to -67.3	-87.5 Percent change Interval -93.3 to -83.3	-71.9 Percent change Interval -80.2 to -58.6	-63.6 Percent change Interval -70.8 to -56.3	-68.8 Percent change Interval -78.9 to -51.8	-74.9 Percent change Interval -81.2 to -66.7	-77.2 Percent change Interval -88.9 to -62.0
Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260 Week 156	-89.3 Percent change Interval -97.4 to -81.0	-67.9 Percent change Interval -75.0 to -60.0	-75.0 Percent change Interval -80.0 to -69.3	-91.7 Percent change Interval -93.8 to -86.4	-79.6 Percent change Interval -91.7 to -58.3	-60.6 Percent change Interval -67.7 to -53.3	-73.9 Percent change Interval -84.6 to -62.5	-66.7 Percent change Interval -74.2 to -59.4	-80.0 Percent change Interval -90.5 to -61.5
Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260 Week 208	-87.5 Percent change Interval -97.4 to -82.1	-81.3 Percent change Interval -88.9 to -72.4	-83.3 Percent change Interval -89.3 to -78.2	-92.1 Percent change Interval -96.0 to -88.3	-75.0 Percent change Interval -86.1 to -56.5	-85.7 Percent change Interval -90.5 to -80.1	-74.1 Percent change Interval -85.6 to -55.4	-84.6 Percent change Interval -88.1 to -78.9	-81.7 Percent change Interval -90.5 to -66.7
Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260 Week 260	-90.9 Percent change Interval -95.5 to -76.2	-84.8 Percent change Interval -91.7 to -76.2	-86.1 Percent change Interval -91.7 to -78.3	-92.3 Percent change Interval -95.0 to -83.3	-75.0 Percent change Interval -100.0 to -44.9	-82.3 Percent change Interval -90.6 to -74.3	-63.9 Percent change Interval -78.4 to -44.4	-83.3 Percent change Interval -89.1 to -76.2	-80.0 Percent change Interval -95.0 to -59.3

SECONDARY outcome

Timeframe: Week 52, Week 104, Week 156, Week 208, Week 260

Outcome measures

Outcome measures
Measure	AIN150FI n=77 Participants AIN457 150 mg - Fixed Interval (FI)	AIN150 FI_AIN300 FI n=75 Participants AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)	AIN300 FI n=152 Participants AIN457 300 mg - Fixed Interval (FI)	AIN150 SoR n=168 Participants AIN457 150 mg - Start of Relapse (SoR)	AIN150 SOR_AIN300 FI n=55 Participants AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)	AIN300 SoR n=95 Participants AIN457 300 mg - Start of Relapse (SoR)	AIN300 SoR _ AIN300 FI n=60 Participants AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)	AIN300 OL n=112 Participants AIN457 300 mg Open-label (OL)	AIN300 OL n=33 Participants AIN457 300 mg Open-label (OL)
Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260 Week 52	59.7 Percentage of participants	57.3 Percentage of participants	58.6 Percentage of participants	72.7 Percentage of participants	32.7 Percentage of participants	34.7 Percentage of participants	28.3 Percentage of participants	41.4 Percentage of participants	54.5 Percentage of participants
Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260 Week 104	54.5 Percentage of participants	47.2 Percentage of participants	50.7 Percentage of participants	64.7 Percentage of participants	41.2 Percentage of participants	33.0 Percentage of participants	32.5 Percentage of participants	41.5 Percentage of participants	36.7 Percentage of participants
Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260 Week 156	66.7 Percentage of participants	37.3 Percentage of participants	47.4 Percentage of participants	67.4 Percentage of participants	43.8 Percentage of participants	35.5 Percentage of participants	38.1 Percentage of participants	38.5 Percentage of participants	50.0 Percentage of participants
Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260 Week 208	62.2 Percentage of participants	52.9 Percentage of participants	56.1 Percentage of participants	70.5 Percentage of participants	30.8 Percentage of participants	62.5 Percentage of participants	42.9 Percentage of participants	59.0 Percentage of participants	52.4 Percentage of participants
Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260 Week 260	55.2 Percentage of participants	54.4 Percentage of participants	54.7 Percentage of participants	65.5 Percentage of participants	60.0 Percentage of participants	55.7 Percentage of participants	15.6 Percentage of participants	56.3 Percentage of participants	50.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 52, Week 104, Week 156

ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)

Outcome measures

Outcome measures
Measure	AIN150FI n=77 Participants AIN457 150 mg - Fixed Interval (FI)	AIN150 FI_AIN300 FI n=75 Participants AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)	AIN300 FI n=152 Participants AIN457 300 mg - Fixed Interval (FI)	AIN150 SoR n=168 Participants AIN457 150 mg - Start of Relapse (SoR)	AIN150 SOR_AIN300 FI n=55 Participants AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)	AIN300 SoR n=95 Participants AIN457 300 mg - Start of Relapse (SoR)	AIN300 SoR _ AIN300 FI n=60 Participants AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)	AIN300 OL n=112 Participants AIN457 300 mg Open-label (OL)	AIN300 OL n=33 Participants AIN457 300 mg Open-label (OL)
EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156 Week 52	68.8 Percent change Standard Deviation 137.47	57.0 Percent change Standard Deviation 137.79	63.0 Percent change Standard Deviation 137.30	115.8 Percent change Standard Deviation 666.41	40.2 Percent change Standard Deviation 94.91	76.9 Percent change Standard Deviation 222.97	41.3 Percent change Standard Deviation 140.42	98.8 Percent change Standard Deviation 359.93	60.9 Percent change Standard Deviation 74.18
EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156 Week 104	58.6 Percent change Standard Deviation 122.96	62.4 Percent change Standard Deviation 156.21	60.6 Percent change Standard Deviation 140.91	118.5 Percent change Standard Deviation 689.52	29.5 Percent change Standard Deviation 70.63	152.9 Percent change Standard Deviation 902.21	46.7 Percent change Standard Deviation 142.85	77.2 Percent change Standard Deviation 150.86	54.3 Percent change Standard Deviation 84.82
EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156 Week 156	61.0 Percent change Standard Deviation 114.81	52.1 Percent change Standard Deviation 115.04	55.2 Percent change Standard Deviation 114.53	125.3 Percent change Standard Deviation 677.23	45.1 Percent change Standard Deviation 102.64	140.3 Percent change Standard Deviation 778.86	13.7 Percent change Standard Deviation 25.16	109.5 Percent change Standard Deviation 373.51	68.1 Percent change Standard Deviation 96.22

SECONDARY outcome

Timeframe: Week 268

Population: The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only descriptive analysis done.

The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment.

Outcome measures

Outcome measures
Measure	AIN150FI n=77 Participants AIN457 150 mg - Fixed Interval (FI)	AIN150 FI_AIN300 FI n=75 Participants AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)	AIN300 FI n=168 Participants AIN457 300 mg - Fixed Interval (FI)	AIN150 SoR n=55 Participants AIN457 150 mg - Start of Relapse (SoR)	AIN150 SOR_AIN300 FI n=95 Participants AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)	AIN300 SoR n=60 Participants AIN457 300 mg - Start of Relapse (SoR)	AIN300 SoR _ AIN300 FI n=112 Participants AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)	AIN300 OL n=33 Participants AIN457 300 mg Open-label (OL)	AIN300 OL AIN457 300 mg Open-label (OL)
Number of Participants With Treatment Emergent Anti-drug Antibodies (ADA)	2 Participants	1 Participants	3 Participants	0 Participants	4 Participants	0 Participants	4 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Week 260

Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.

Outcome measures

Outcome measures
Measure	AIN150FI n=77 Participants AIN457 150 mg - Fixed Interval (FI)	AIN150 FI_AIN300 FI n=75 Participants AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)	AIN300 FI n=168 Participants AIN457 300 mg - Fixed Interval (FI)	AIN150 SoR n=55 Participants AIN457 150 mg - Start of Relapse (SoR)	AIN150 SOR_AIN300 FI n=95 Participants AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)	AIN300 SoR n=60 Participants AIN457 300 mg - Start of Relapse (SoR)	AIN300 SoR _ AIN300 FI n=112 Participants AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)	AIN300 OL n=33 Participants AIN457 300 mg Open-label (OL)	AIN300 OL AIN457 300 mg Open-label (OL)
Percentage of Patients With Experiencing a Relapse	31.2 Percentage of Participants	40.0 Percentage of Participants	19.6 Percentage of Participants	61.8 Percentage of Participants	52.6 Percentage of Participants	43.3 Percentage of Participants	56.3 Percentage of Participants	36.4 Percentage of Participants	—

SECONDARY outcome

Timeframe: Up to Week 264 (8 weeks post last dose)

Rebound of disease is defined as a worsening of PASI of \> 125% of the value at baseline (core study), or new pustular, erythrodermic or more inflammatory psoriasis occurring within 8 weeks of stopping therapy (i.e., if this definition was fulfilled at more than 8 weeks after last study treatment administration, this was defined as rebound like event). PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.

Outcome measures

Outcome measures
Measure	AIN150FI n=77 Participants AIN457 150 mg - Fixed Interval (FI)	AIN150 FI_AIN300 FI n=75 Participants AIN457 150 mg FI switch to AIN457 300 mg FI (150 mg FI SW)	AIN300 FI n=168 Participants AIN457 300 mg - Fixed Interval (FI)	AIN150 SoR n=55 Participants AIN457 150 mg - Start of Relapse (SoR)	AIN150 SOR_AIN300 FI n=95 Participants AIN457 150 mg SoR switch to AIN457 300 mg FI (150 mg SoR SW)	AIN300 SoR n=60 Participants AIN457 300 mg - Start of Relapse (SoR)	AIN300 SoR _ AIN300 FI n=112 Participants AIN457 300 mg SoR switch to AIN457 300 mg FI (300 mg SoR SW)	AIN300 OL n=33 Participants AIN457 300 mg Open-label (OL)	AIN300 OL AIN457 300 mg Open-label (OL)
Percentage of Patients With Experiencing a Rebound	11.5 Percentage of participants Interval 5.1 to 22.8	5.8 Percentage of participants Interval 1.9 to 14.9	5.0 Percentage of participants Interval 2.2 to 10.3	9.4 Percentage of participants Interval 2.5 to 26.2	1.1 Percentage of participants Interval 0.1 to 7.0	6.9 Percentage of participants Interval 1.2 to 24.2	10.6 Percentage of participants Interval 5.7 to 18.5	13.0 Percentage of participants Interval 3.4 to 34.7	—

Adverse Events

Any AIN457 150 mg

Serious events: 25 serious events

Other events: 93 other events

Deaths: 0 deaths

Any AIN457 300 mg

Serious events: 119 serious events

Other events: 449 other events

Deaths: 4 deaths

Any AIN457 Dose

Serious events: 144 serious events

Other events: 542 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

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 (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Any AIN457 150 mg n=132 participants at risk Any AIN457 150 mg	Any AIN457 300 mg n=543 participants at risk Any AIN457 300 mg	Any AIN457 Dose n=675 participants at risk Any AIN457 dose
Injury, poisoning and procedural complications RIB FRACTURE	0.76% 1/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.00% 0/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Blood and lymphatic system disorders AUTOIMMUNE HAEMOLYTIC ANAEMIA	0.76% 1/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.00% 0/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Blood and lymphatic system disorders LYMPHOID TISSUE HYPERPLASIA	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.55% 3/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.44% 3/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders ANGINA UNSTABLE	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.37% 2/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.30% 2/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders AORTIC VALVE DISEASE	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders ARRHYTHMIA	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders ARRHYTHMIA SUPRAVENTRICULAR	0.76% 1/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.00% 0/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders ATRIAL FIBRILLATION	0.76% 1/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.74% 4/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.74% 5/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders ATRIAL FLUTTER	0.76% 1/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.00% 0/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders BRADYCARDIA	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders BUNDLE BRANCH BLOCK LEFT	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders CARDIAC FAILURE ACUTE	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders CARDIAC FAILURE CHRONIC	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.37% 2/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.30% 2/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders CONGESTIVE CARDIOMYOPATHY	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.37% 2/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.30% 2/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders CORONARY ARTERY OCCLUSION	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders CORONARY OSTIAL STENOSIS	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders LEFT VENTRICULAR DYSFUNCTION	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders LONG QT SYNDROME	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders MYOCARDIAL INFARCTION	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.37% 2/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.30% 2/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders MYOCARDITIS	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders TACHYCARDIA	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Ear and labyrinth disorders VESTIBULAR DISORDER	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders ANAL INCONTINENCE	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders GASTRIC ULCER HAEMORRHAGE	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders GASTRITIS	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders LARGE INTESTINE POLYP	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders LEUKOPLAKIA ORAL	0.76% 1/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.00% 0/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders PANCREATITIS ACUTE	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.37% 2/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.30% 2/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders TOOTHACHE	0.76% 1/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.00% 0/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders UMBILICAL HERNIA	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.55% 3/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.44% 3/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
General disorders PERIPHERAL SWELLING	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.15% 1/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.

Other adverse events
Measure	Any AIN457 150 mg n=132 participants at risk Any AIN457 150 mg	Any AIN457 300 mg n=543 participants at risk Any AIN457 300 mg	Any AIN457 Dose n=675 participants at risk Any AIN457 dose
Cardiac disorders TACHYCARDIA	2.3% 3/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.18% 1/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.59% 4/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Endocrine disorders HYPERTHYROIDISM	2.3% 3/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.00% 0/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	0.44% 3/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders ABDOMINAL PAIN	2.3% 3/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.0% 11/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.1% 14/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders DENTAL CARIES	0.76% 1/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.0% 11/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	1.8% 12/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders DIARRHOEA	6.1% 8/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	5.9% 32/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	5.9% 40/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders GASTRITIS	3.0% 4/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.4% 13/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.5% 17/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	2.3% 3/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.2% 12/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.2% 15/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders NAUSEA	6.1% 8/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	1.7% 9/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.5% 17/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders TOOTHACHE	3.8% 5/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.9% 21/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.9% 26/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders VOMITING	0.76% 1/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.9% 16/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.5% 17/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
General disorders FATIGUE	3.8% 5/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.9% 16/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.1% 21/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
General disorders NON-CARDIAC CHEST PAIN	3.0% 4/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.4% 13/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.5% 17/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
General disorders OEDEMA PERIPHERAL	2.3% 3/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.1% 17/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.0% 20/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
General disorders PYREXIA	2.3% 3/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.6% 14/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.5% 17/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Hepatobiliary disorders HEPATIC STEATOSIS	2.3% 3/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	1.7% 9/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	1.8% 12/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Immune system disorders SEASONAL ALLERGY	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.9% 16/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.4% 16/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations BRONCHITIS	5.3% 7/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	9.4% 51/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	8.6% 58/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations CELLULITIS	0.76% 1/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.8% 15/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.4% 16/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations CONJUNCTIVITIS	2.3% 3/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.5% 19/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.3% 22/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations FOLLICULITIS	2.3% 3/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	4.6% 25/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	4.1% 28/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations FURUNCLE	1.5% 2/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.0% 11/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	1.9% 13/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations GASTROENTERITIS	4.5% 6/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	4.2% 23/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	4.3% 29/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations HERPES ZOSTER	4.5% 6/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.4% 13/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.8% 19/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations INFLUENZA	9.1% 12/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	7.7% 42/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	8.0% 54/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations NASOPHARYNGITIS	23.5% 31/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	34.1% 185/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	32.0% 216/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations ORAL HERPES	0.76% 1/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.5% 19/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.0% 20/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations PHARYNGITIS	3.8% 5/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	5.2% 28/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	4.9% 33/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations RHINITIS	3.0% 4/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	4.1% 22/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.9% 26/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations SINUSITIS	6.1% 8/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	5.5% 30/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	5.6% 38/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations TINEA PEDIS	2.3% 3/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.2% 12/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.2% 15/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations TONSILLITIS	3.8% 5/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.7% 20/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.7% 25/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations TOOTH ABSCESS	1.5% 2/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.8% 15/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.5% 17/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	9.8% 13/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	11.4% 62/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	11.1% 75/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations URINARY TRACT INFECTION	3.0% 4/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	4.2% 23/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	4.0% 27/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	4.8% 26/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.9% 26/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Injury, poisoning and procedural complications ARTHROPOD BITE	0.76% 1/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.4% 13/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.1% 14/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Injury, poisoning and procedural complications CONTUSION	1.5% 2/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	4.1% 22/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.6% 24/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Injury, poisoning and procedural complications FALL	0.00% 0/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.0% 11/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	1.6% 11/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Injury, poisoning and procedural complications LIGAMENT SPRAIN	0.76% 1/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	2.2% 12/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	1.9% 13/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Injury, poisoning and procedural complications MUSCLE STRAIN	0.76% 1/132 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.5% 19/543 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.	3.0% 20/675 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 4 years and 7 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.