Trial Outcomes & Findings for Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma (NCT NCT03681093)

Last Updated: 2021-10-11

Results Overview

Nasal Polyp Score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 \[no polyp\] to 4 \[large polyps\] for each nostril), with a lower score indicating smaller-sized polyps. Baseline NPS is defined as the last measurement performed on or before the date of randomization. A negative change from baseline in NPS is considered a favorable outcome.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

98 participants

Primary outcome timeframe

Baseline, Week 16

Results posted on

2021-10-11

Participant Flow

Participants took part in 25 investigative sites in 9 countries.

After the screening, participants went through a Run-in period of 4 weeks where they utilized mometasone furoate spray into each nostril. Afterwards, patients were randomized in 1:1:1 ratio in either of the 3 arms and continued to use the mometasone furoate spray.

Participant milestones

Participant milestones
Measure	Fevipiprant 150 mg Fevipiprant (QAW039) 150 mg once daily orally	Fevipiprant 450 mg Fevipiprant (QAW039) 450 mg once daily orally	Placebo Placebo once daily orally
Overall Study STARTED	32	34	32
Overall Study Full Analysis Set (FAS)	31	32	28
Overall Study Safety Analysis Set (SAF)	32	34	32
Overall Study COMPLETED	32	32	31
Overall Study NOT COMPLETED	0	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Fevipiprant 150 mg Fevipiprant (QAW039) 150 mg once daily orally	Fevipiprant 450 mg Fevipiprant (QAW039) 450 mg once daily orally	Placebo Placebo once daily orally
Overall Study Subject decision	0	2	1

Baseline Characteristics

Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fevipiprant 150 mg n=32 Participants Fevipiprant (QAW039) 150 mg once daily orally	Fevipiprant 450 mg n=34 Participants Fevipiprant (QAW039) 450 mg once daily orally	Placebo n=32 Participants Placebo once daily orally	Total n=98 Participants Total of all reporting groups
Age, Continuous	50.8 years STANDARD_DEVIATION 13.36 • n=5 Participants	50.9 years STANDARD_DEVIATION 13.10 • n=7 Participants	48.5 years STANDARD_DEVIATION 13.43 • n=5 Participants	50.1 years STANDARD_DEVIATION 13.20 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	43 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	19 Participants n=7 Participants	20 Participants n=5 Participants	55 Participants n=4 Participants
Race/Ethnicity, Customized White	32 Participants n=5 Participants	34 Participants n=7 Participants	31 Participants n=5 Participants	97 Participants n=4 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	Fevipiprant 150 mg n=31 Participants Fevipiprant (QAW039) 150 mg once daily orally	Fevipiprant 450 mg n=32 Participants Fevipiprant (QAW039) 450 mg once daily orally	Placebo n=28 Participants Placebo once daily orally
Change From Baseline in Nasal Polyp Score at Week 16	0.20 score on scale Standard Error 0.224	-0.10 score on scale Standard Error 0.216	0.14 score on scale Standard Error 0.233

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Full Analysis Set

The nasal congestion score (NCS) is assessed via a questionnaire where patients are asked "Is your nose blocked?" with responses ranging from 0 = not at all, to 3=severe. Baseline NCS is defined as the last assessment performed on or before the date of randomization. A negative change from baseline in NCS is considered a favorable outcome.

Outcome measures

Outcome measures
Measure	Fevipiprant 150 mg n=31 Participants Fevipiprant (QAW039) 150 mg once daily orally	Fevipiprant 450 mg n=32 Participants Fevipiprant (QAW039) 450 mg once daily orally	Placebo n=28 Participants Placebo once daily orally
Change From Baseline in Nasal Congestion Score at Week 16	-0.15 score on scale Standard Error 0.172	-0.35 score on scale Standard Error 0.171	-0.80 score on scale Standard Error 0.181

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Full Analysis Set

SNOT-22 (Sino-Nasal Outcome Test) Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been for them over the past 2 weeks on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. Baseline SNOT-22 is defined as the last assessment performed on or before the date of randomization. A negative change from baseline in SNOT-22 is considered a favorable outcome.

Outcome measures

Outcome measures
Measure	Fevipiprant 150 mg n=31 Participants Fevipiprant (QAW039) 150 mg once daily orally	Fevipiprant 450 mg n=32 Participants Fevipiprant (QAW039) 450 mg once daily orally	Placebo n=28 Participants Placebo once daily orally
Change From Baseline in Quality of Life as Assessed by the SNOT-22 Questionnaire at Week 16	-3.23 score on scale Standard Error 3.349	-10.61 score on scale Standard Error 3.358	-8.44 score on scale Standard Error 3.571

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Full Analysis Set

The UPSIT (University of Pennsylvania Smell Identification Test) is a test that measures an individual's ability to detect odors. It consists of 4 workbooks of 10 pages each. On each page there is a different "scratch and sniff" strip which is embedded with a microencapsulated odorant and a question regarding the smell detected with a four-choice option for the response. The total number of questions in UPSIT is 40. The number of correct responses regarding the smells being experienced is summed to provide a total score that ranges from 0 to 40, with a higher score indicating a better sense of smell. Baseline UPSIT is defined as the last assessment performed on or before the date of randomization. A positive change from baseline in UPSIT is considered a favorable outcome.

Outcome measures

Outcome measures
Measure	Fevipiprant 150 mg n=31 Participants Fevipiprant (QAW039) 150 mg once daily orally	Fevipiprant 450 mg n=32 Participants Fevipiprant (QAW039) 450 mg once daily orally	Placebo n=28 Participants Placebo once daily orally
Change From Baseline in Sense of Smell as Assessed by the University of Pennsylvania Smell Identification Test (UPSIT) at Week 16	1.05 score on scale Standard Error 1.242	4.95 score on scale Standard Error 1.259	0.44 score on scale Standard Error 1.315

Adverse Events

Fevipiprant 150 mg

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Fevipiprant 450 mg

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

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. 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

Other adverse events
Measure	Fevipiprant 150 mg n=32 participants at risk Fevipiprant (QAW039) 150 mg once daily orally	Fevipiprant 450 mg n=34 participants at risk Fevipiprant (QAW039) 450 mg once daily orally	Placebo n=32 participants at risk Placebo once daily orally
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	2.9% 1/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Ear and labyrinth disorders Ear pain	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	2.9% 1/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Eye disorders Conjunctival haemorrhage	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	2.9% 1/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Gastrointestinal disorders Mouth ulceration	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Gastrointestinal disorders Tongue discomfort	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Gastrointestinal disorders Vomiting	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
General disorders Peripheral swelling	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
General disorders Pyrexia	6.2% 2/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Acute sinusitis	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Bronchitis	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	2.9% 1/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Ear infection	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Gastric infection	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Gastroenteritis viral	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Gingivitis	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Influenza	6.2% 2/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	2.9% 1/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	6.2% 2/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Laryngitis	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	2.9% 1/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Nasopharyngitis	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	6.2% 2/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Oral herpes	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	5.9% 2/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Otitis media	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	2.9% 1/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Pharyngitis	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	2.9% 1/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Sinusitis	9.4% 3/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	2.9% 1/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	6.2% 2/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Tonsillitis	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	2.9% 1/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Upper respiratory tract infection	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	2.9% 1/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Investigations Amylase increased	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Investigations Blood creatine phosphokinase increased	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Investigations Blood creatinine increased	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Investigations Lipase increased	6.2% 2/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Investigations Weight increased	6.2% 2/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	2.9% 1/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Metabolism and nutrition disorders Metabolic syndrome	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Musculoskeletal and connective tissue disorders Arthritis	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	2.9% 1/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Nervous system disorders Dizziness	3.1% 1/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Nervous system disorders Facial paralysis	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	2.9% 1/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Nervous system disorders Headache	6.2% 2/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	2.9% 1/34 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.	0.00% 0/32 • From first dose of study treatment until end of study treatment plus 2 weeks post treatment, up to Week 18. Any sign or symptom that occurs during the study treatment plus 2 weeks post treatment.