Trial Outcomes & Findings for Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque Psoriasis (NCT NCT03504852)

Last Updated: 2021-10-11

Results Overview

A subject was considered as a PASI 90 responder if s/he achieved a reduction of 90% or more of the PASI score, compared to baseline, at a given time point.The head, trunk, upper limbs and lower limbs were assessed separately for erythema, thickening, and scaling. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, i.e., higher scores represent more severity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

331 participants

Primary outcome timeframe

16 weeks

Results posted on

2021-10-11

Participant Flow

331 participants in the study were randomized and 330 participants were treated. (One participant in the Secukinumab 300 mg Q4W arm was randomized but not treated. This participant was included in the randomization (demographic and disposition) set and the full analysis set, but was not included in the safety (Adverse Events) set.)

Participant milestones

Participant milestones
Measure	Secukinumab 300 mg Every 2 Weeks (Q2W) 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.	Secukinumab 300 mg Every 4 Weeks (Q4W) (Safety) 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.	Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up) 2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).
Overall Study STARTED	165	135	31
Overall Study COMPLETED	148	117	28
Overall Study NOT COMPLETED	17	18	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Secukinumab 300 mg Every 2 Weeks (Q2W) 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.	Secukinumab 300 mg Every 4 Weeks (Q4W) (Safety) 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.	Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up) 2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).
Overall Study Withdrawal of informed consent	2	1	0
Overall Study Withdrawal by Subject	5	5	1
Overall Study Lost to Follow-up	4	1	0
Overall Study New therapy for study indication	1	0	0
Overall Study Lack of Efficacy	1	2	0
Overall Study Death	0	1	0
Overall Study Adverse Event	4	8	2

Baseline Characteristics

Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Secukinumab 300 mg Every 2 Weeks (Q2W) n=165 Participants 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.	Secukinumab 300 mg Every 4 Weeks (Q4W) (Safety) n=135 Participants 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.	Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up) n=31 Participants 2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).	Total n=331 Participants Total of all reporting groups
Age, Continuous	48.2 years STANDARD_DEVIATION 12.73 • n=5 Participants	46.1 years STANDARD_DEVIATION 13.24 • n=7 Participants	44.7 years STANDARD_DEVIATION 13.61 • n=5 Participants	47.1 years STANDARD_DEVIATION 13.04 • n=4 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	34 Participants n=7 Participants	10 Participants n=5 Participants	83 Participants n=4 Participants
Sex: Female, Male Male	126 Participants n=5 Participants	101 Participants n=7 Participants	21 Participants n=5 Participants	248 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) White	151 Participants n=5 Participants	125 Participants n=7 Participants	30 Participants n=5 Participants	306 Participants n=4 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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Full analysis set. Please note that the Secukinumab 300 mg every 4 weeks non-responders up-titration (Q4W NR up) arm did not apply to this efficacy outcome measure and therefore no results are reported here for this arm.

Outcome measures

Outcome measures
Measure	Secukinumab 300 mg Every 2 Weeks (Q2W) n=165 Participants 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.	Secukinumab 300 mg Every 4 Weeks (Q4W) (up to Week 16 Pre-dose) n=166 Participants Subjects received 2 injections of secukinumab 150 mg once weekly for four weeks (at Randomization, Weeks 1, 2 and 3), followed by 2 injections of secukinumab 150 mg every four weeks, starting at Week 4 and up to Week 12.	Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up) 2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).
Percentage of Subjects Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set)	121 Participants	92 Participants	—

SECONDARY outcome

Timeframe: 16 weeks

IGA mod 2011 was conducted for overall psoriatic disease. The IGA modified 2011 used in this study was static, i.e., it referred exclusively to the subject's disease state at the time of the assessments, and did not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit. The scale has 0 (clear) as min and 4 (severe) as max, i.e., a higher score indicates more severity.

Outcome measures

Outcome measures
Measure	Secukinumab 300 mg Every 2 Weeks (Q2W) n=165 Participants 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.	Secukinumab 300 mg Every 4 Weeks (Q4W) (up to Week 16 Pre-dose) n=166 Participants Subjects received 2 injections of secukinumab 150 mg once weekly for four weeks (at Randomization, Weeks 1, 2 and 3), followed by 2 injections of secukinumab 150 mg every four weeks, starting at Week 4 and up to Week 12.	Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up) 2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).
Percentage of Subjects Who Achieve Investigator Global Assessment (IGA Modified 2011) Score of 0 or 1 - Week 16 (Full Analysis Set)	122 Participants	109 Participants	—

SECONDARY outcome

Timeframe: Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.

Population: safety set - includes the results for the Secukinumab 300 mg every 4 weeks non-responders up-titration (Q4W NR up) arm.

An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.

Outcome measures

Outcome measures
Measure	Secukinumab 300 mg Every 2 Weeks (Q2W) n=165 Participants 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.	Secukinumab 300 mg Every 4 Weeks (Q4W) (up to Week 16 Pre-dose) n=134 Participants Subjects received 2 injections of secukinumab 150 mg once weekly for four weeks (at Randomization, Weeks 1, 2 and 3), followed by 2 injections of secukinumab 150 mg every four weeks, starting at Week 4 and up to Week 12.	Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up) n=31 Participants 2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).
Absolute and Relative Frequencies for Deaths, Other Serious or Clinically Significant Adverse Events or Related Discontinuations - Entire Study Period (Safety Set) Patients with any AE(s)	127 Participants	97 Participants	24 Participants
Absolute and Relative Frequencies for Deaths, Other Serious or Clinically Significant Adverse Events or Related Discontinuations - Entire Study Period (Safety Set) Patients with serious or other significant events - Death	0 Participants	1 Participants	0 Participants
Absolute and Relative Frequencies for Deaths, Other Serious or Clinically Significant Adverse Events or Related Discontinuations - Entire Study Period (Safety Set) Patients with serious or other significant events - Non-fatal SAE(s)	14 Participants	17 Participants	4 Participants
Absolute and Relative Frequencies for Deaths, Other Serious or Clinically Significant Adverse Events or Related Discontinuations - Entire Study Period (Safety Set) Patients with serious or other significant events - Discontinued study treatment due to any AE(s)	4 Participants	9 Participants	2 Participants

Adverse Events

Secukinumab 300 mg Every 2 Weeks (Q2W)

Serious events: 14 serious events

Other events: 66 other events

Deaths: 0 deaths

Secukinumab 300 mg Every 4 Weeks (Q4W) (Safety)

Serious events: 18 serious events

Other events: 57 other events

Deaths: 1 deaths

Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up)

Serious events: 4 serious events

Other events: 16 other events

Deaths: 0 deaths

All Patients

Serious events: 36 serious events

Other events: 139 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 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 (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Secukinumab 300 mg Every 2 Weeks (Q2W) n=165 participants at risk 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.	Secukinumab 300 mg Every 4 Weeks (Q4W) (Safety) n=134 participants at risk 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.	Secukinumab 300 mg Every 4 Weeks Non-responders Up-titration (Q4W NR up) n=31 participants at risk 2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).	All Patients n=330 participants at risk All Patients
Gastrointestinal disorders Diarrhoea	6.1% 10/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	4.5% 6/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	6.5% 2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	5.5% 18/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Gastrointestinal disorders Nausea	0.61% 1/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	3.0% 4/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	6.5% 2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	2.1% 7/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
General disorders Fatigue	2.4% 4/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	2.2% 3/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	6.5% 2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	2.7% 9/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
General disorders Pyrexia	1.2% 2/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	1.5% 2/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	6.5% 2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	1.8% 6/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Infections and infestations Nasopharyngitis	19.4% 32/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	16.4% 22/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	16.1% 5/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	17.9% 59/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Infections and infestations Tooth abscess	0.61% 1/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	0.00% 0/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	6.5% 2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	0.91% 3/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Infections and infestations Upper respiratory tract infection	7.3% 12/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	6.7% 9/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	9.7% 3/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	7.3% 24/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Infections and infestations Urinary tract infection	0.61% 1/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	3.7% 5/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	6.5% 2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	2.4% 8/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	0.75% 1/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	6.5% 2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	0.91% 3/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Investigations Neutrophil count decreased	0.61% 1/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	2.2% 3/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	9.7% 3/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	2.1% 7/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Metabolism and nutrition disorders Diabetes mellitus	1.8% 3/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	0.00% 0/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	6.5% 2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	1.5% 5/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Musculoskeletal and connective tissue disorders Arthralgia	4.2% 7/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	4.5% 6/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	6.5% 2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	4.5% 15/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Musculoskeletal and connective tissue disorders Back pain	1.8% 3/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	4.5% 6/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	6.5% 2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	3.3% 11/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Nervous system disorders Headache	6.7% 11/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	4.5% 6/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	3.2% 1/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	5.5% 18/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Respiratory, thoracic and mediastinal disorders Cough	4.2% 7/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	1.5% 2/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	6.5% 2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	3.3% 11/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.8% 3/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	5.2% 7/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	6.5% 2/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	3.6% 12/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Skin and subcutaneous tissue disorders Intertrigo	2.4% 4/165 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	0.00% 0/134 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	9.7% 3/31 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.	2.1% 7/330 • Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.