Trial Outcomes & Findings for A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241) (NCT NCT01471340)

NCT ID: NCT01471340

Last Updated: 2024-05-23

Results Overview

The primary safety outcome was the time-to-first SAO (a composite endpoint of adjudicated asthma-related hospitalizations, adjudicated asthma-related intubations, and adjudicated asthma-related deaths). To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment (or 7 days after the last treatment dose, whichever occurred later). Data generated by this methodology were used to compute a hazard ratio (HR) and 95% confidence interval (CI), modeling the likelihood of a first SAO occurring at any given time in the MF/F arm relative to the MF arm. Although data were sufficient to generate a HR and 95% CI, time-to-first SAO in the overall population could not be accurately reported due to insufficient SAO occurrence. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 11744 participants
• Primary outcome timeframe: 26 weeks, or 7 days after the last treatment dose, whichever occurred later
• Results posted on: 2024-05-23

Participant Flow

11,744 participants were enrolled in the study and 11,729 participants were randomized and received at least one dose of blinded study treatment (defined as the number started). Treatments were Mometasone Furoate/Formoterol (MF/F) metered dose inhaler (MDI) twice daily (BID) and Mometasone Furoate (MF) MDI BID.

Participant milestones

Measure	Mometasone Furoate/Formoterol (MF/F) MDI BID MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily (pooled MF/F treatments), with oral inhalation of a pressurized inhalation aerosol	Mometasone Furoate (MF) MDI BID MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily (pooled MF treatments), with oral inhalation of a pressurized inhalation aerosol
Overall Study STARTED	5868	5861
Overall Study COMPLETED	5862	5855
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Measure	Mometasone Furoate/Formoterol (MF/F) MDI BID MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily (pooled MF/F treatments), with oral inhalation of a pressurized inhalation aerosol	Mometasone Furoate (MF) MDI BID MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily (pooled MF treatments), with oral inhalation of a pressurized inhalation aerosol
Overall Study Death	5	4
Overall Study Lost to Follow-up	0	1
Overall Study Investigational site closure	0	1
Overall Study Invalid informed consent	1	0

Baseline Characteristics

A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241)

Baseline characteristics by cohort

Measure	Mometasone Furoate/Formoterol (MF/F) MDI BID n=5868 Participants MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily, with oral inhalation of a pressurized inhalation aerosol	Mometasone Furoate (MF) MDI BID n=5861 Participants MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily, with oral inhalation of a pressurized inhalation aerosol	Total n=11729 Participants Total of all reporting groups
Age, Continuous	45.3 Years STANDARD_DEVIATION 17.19 • n=5 Participants	44.8 Years STANDARD_DEVIATION 17.55 • n=7 Participants	45.1 Years STANDARD_DEVIATION 17.37 • n=5 Participants
Sex: Female, Male Female	3841 Participants n=5 Participants	3875 Participants n=7 Participants	7716 Participants n=5 Participants
Sex: Female, Male Male	2027 Participants n=5 Participants	1986 Participants n=7 Participants	4013 Participants n=5 Participants
Treatment Covariates (MF/F or MF) and ICS Dose Level (100 or 200 mcg, per actuation) MF/F 200/10 mcg	3604 Participants n=5 Participants	0 Participants n=7 Participants	3604 Participants n=5 Participants
Treatment Covariates (MF/F or MF) and ICS Dose Level (100 or 200 mcg, per actuation) MF/F 400/10 mcg	2264 Participants n=5 Participants	0 Participants n=7 Participants	2264 Participants n=5 Participants
Treatment Covariates (MF/F or MF) and ICS Dose Level (100 or 200 mcg, per actuation) MF 200 mcg	0 Participants n=5 Participants	3601 Participants n=7 Participants	3601 Participants n=5 Participants
Treatment Covariates (MF/F or MF) and ICS Dose Level (100 or 200 mcg, per actuation) MF 400 mcg	0 Participants n=5 Participants	2260 Participants n=7 Participants	2260 Participants n=5 Participants

PRIMARY outcome

Timeframe: 26 weeks, or 7 days after the last treatment dose, whichever occurred later

Population: The analyzed population for assessment of the number of first SAO was all participants who received at least one dose of randomized treatment assignment (intention-to-treat principle).

The primary safety outcome was the time-to-first SAO (a composite endpoint of adjudicated asthma-related hospitalizations, adjudicated asthma-related intubations, and adjudicated asthma-related deaths). To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment (or 7 days after the last treatment dose, whichever occurred later). Data generated by this methodology were used to compute a hazard ratio (HR) and 95% confidence interval (CI), modeling the likelihood of a first SAO occurring at any given time in the MF/F arm relative to the MF arm. Although data were sufficient to generate a HR and 95% CI, time-to-first SAO in the overall population could not be accurately reported due to insufficient SAO occurrence. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant.

Outcome measures

Measure	MF/F MDI BID n=5868 Participants MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily (pooled MF/F treatments), with oral inhalation of a pressurized inhalation aerosol	MF MDI BID n=5861 Participants MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily (pooled MF treatments), with oral inhalation of a pressurized inhalation aerosol
Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms	39 Serious asthma outcomes	32 Serious asthma outcomes

SECONDARY outcome

Timeframe: 26 weeks, plus 7 days after the last treatment

Population: The analyzed population for assessment of the number of first asthma exacerbations was all treated participants who received at least one dose of randomized treatment assignment (intention-to-treat principle).

The key secondary efficacy outcome was time-to-first protocol-defined asthma exacerbation (SAEX). The SAEX were deteriorations of asthma requiring: use of systemic corticosteroids (tablets, suspension, or injection) for >= 3 consecutive days, in-patient hospitalization >= 24 hours, or an emergency department (ED) visit < 24 hours that required systemic corticosteroids in the MF/F MDI BID arm versus the MF MDI BID arm. The number of first SAEX occurred from initiation of study treatment to 7 days after the last treatment (modified intention-to-treat). This outcome was measured as the HR and 95% CI for the number of first SAEX in the MF/F MDI BID arm versus the number of first SAEX in the MF MDI BID arm. Given insufficient data for SAEX events, it was not informative to report the time-to-first SAEX in the overall population. Therefore, the number of first SAEXs in either arm is reported as a descriptive measure. For each participant, first SAEX denotes first event per participant.

Outcome measures

Measure	MF/F MDI BID n=5868 Participants MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily (pooled MF/F treatments), with oral inhalation of a pressurized inhalation aerosol	MF MDI BID n=5861 Participants MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily (pooled MF treatments), with oral inhalation of a pressurized inhalation aerosol
Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms	708 Asthma exacerbations	779 Asthma exacerbations

OTHER_PRE_SPECIFIED outcome

Timeframe: 26 weeks, or 7 days after the last treatment dose, whichever occurred later

Population: The analyzed population for tabulation of the number of SAO components was all participants who received at least one dose of randomized treatment assignment (intention-to-treat principle).

To further examine the primary safety outcome, each adjudicated component of the SAO composite endpoint (asthma-related hospitalization, asthma-related intubation and asthma-related death), was tabulated for descriptive purposes only to show the relative contribution of each component to the SAO composite. Hospitalizations were defined as an in-patient stay of >= 24 hour in a hospital, emergency department or equivalent healthcare facility. Intubation was defined as endotracheal intubation only.

Outcome measures

Measure	MF/F MDI BID n=5868 Participants MF/F MDI administered as two puffs of 100/5 mcg or 200/5 mcg, twice daily (pooled MF/F treatments), with oral inhalation of a pressurized inhalation aerosol	MF MDI BID n=5861 Participants MF MDI administered as two puffs of 100 mcg or 200 mcg, twice daily (pooled MF treatments), with oral inhalation of a pressurized inhalation aerosol
Number of SAO Components in MF/F Participants vs MF Participants Asthma-related hospitalizations	39 SAO components	32 SAO components
Number of SAO Components in MF/F Participants vs MF Participants Asthma-related intubations	0 SAO components	0 SAO components
Number of SAO Components in MF/F Participants vs MF Participants Asthma-related deaths	0 SAO components	0 SAO components
Number of SAO Components in MF/F Participants vs MF Participants First SAO	39 SAO components	32 SAO components

Adverse Events

MF/F MDI BID

Serious events: 136 serious events

Other events: 67 other events

Deaths: 5 deaths

MF MDI BID

Serious events: 137 serious events

Other events: 75 other events

Deaths: 4 deaths

Serious adverse events

Measure	MF/F MDI BID n=5868 participants at risk	MF MDI BID n=5861 participants at risk
Injury, poisoning and procedural complications Intentional product misuse	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Injury, poisoning and procedural complications Joint dislocation	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Injury, poisoning and procedural complications Limb injury	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Acute myocardial infarction	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Angina pectoris	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Atrial fibrillation	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Atrial tachycardia	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Atrioventricular block complete	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Atrioventricular block second degree	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Cardiac failure	0.05% 3/5868 • Number of events 3 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Cardiac failure congestive	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Cardiomegaly	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Coronary artery thrombosis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Diastolic dysfunction	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Mitral valve stenosis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Myocardial infarction	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Tachycardia	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Ear and labyrinth disorders Vertigo positional	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Endocrine disorders Autoimmune thyroiditis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Endocrine disorders Basedow's disease	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Eye disorders Retinal detachment	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Diarrhoea	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Epiploic appendagitis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Functional gastrointestinal disorder	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Gastric dysplasia	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Gastritis	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Gastrointestinal necrosis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Gastrooesophageal sphincter insufficiency	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Ileus	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Inguinal hernia	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Pancreatitis chronic	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Subileus	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Umbilical hernia	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
General disorders Chest pain	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
General disorders Non-cardiac chest pain	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
General disorders Pyrexia	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
General disorders Systemic inflammatory response syndrome	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Hepatobiliary disorders Biliary colic	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Hepatobiliary disorders Cholangitis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Hepatobiliary disorders Cholecystitis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Hepatobiliary disorders Cholecystitis acute	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Hepatobiliary disorders Cholelithiasis	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Immune system disorders Food allergy	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Abscess intestinal	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Anicteric leptospirosis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Appendicitis	0.10% 6/5868 • Number of events 6 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.07% 4/5861 • Number of events 4 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Bronchitis	0.05% 3/5868 • Number of events 3 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Clostridium difficile colitis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Diverticulitis	0.05% 3/5868 • Number of events 3 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Eczema infected	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Gastroenteritis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Helicobacter gastritis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Infectious mononucleosis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Influenza	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Lower respiratory tract infection	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Meningitis cryptococcal	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Meningitis viral	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Peritonitis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Peritonsillar abscess	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Pilonidal cyst	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Pneumonia	0.17% 10/5868 • Number of events 11 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.10% 6/5861 • Number of events 6 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Pneumonia bacterial	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Pneumonia pseudomonal	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Post procedural infection	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Pyelonephritis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Sinusitis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Upper respiratory tract infection	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Viral infection	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Injury, poisoning and procedural complications Accidental overdose	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Injury, poisoning and procedural complications Ankle fracture	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.07% 4/5861 • Number of events 4 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Injury, poisoning and procedural complications Burns third degree	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Injury, poisoning and procedural complications Contusion	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Injury, poisoning and procedural complications Fall	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Injury, poisoning and procedural complications Head injury	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Injury, poisoning and procedural complications Lower limb fracture	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Injury, poisoning and procedural complications Meniscus injury	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Injury, poisoning and procedural complications Radius fracture	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Injury, poisoning and procedural complications Tibia fracture	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.05% 3/5861 • Number of events 3 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Injury, poisoning and procedural complications Ulna fracture	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Investigations Chest X-ray abnormal	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Metabolism and nutrition disorders Dehydration	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Metabolism and nutrition disorders Hyperkalaemia	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Metabolism and nutrition disorders Hyperosmolar state	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Metabolism and nutrition disorders Obesity	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Musculoskeletal and connective tissue disorders Arthralgia	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Musculoskeletal and connective tissue disorders Chondropathy	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Musculoskeletal and connective tissue disorders Osteolysis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of spinal cord	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour of the duodenum	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary thyroid cancer	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Cerebrovascular accident	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Encephalitis autoimmune	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Facial paresis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Headache	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Hemiparesis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders IIIrd nerve paralysis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Ischaemic stroke	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Lacunar infarction	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Multiple sclerosis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Sciatica	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Spondylitic myelopathy	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Syncope	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Trigeminal neuralgia	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Pregnancy, puerperium and perinatal conditions Abortion incomplete	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Pregnancy, puerperium and perinatal conditions Foetal death	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Psychiatric disorders Acute psychosis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Psychiatric disorders Alcohol abuse	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Psychiatric disorders Alcoholism	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Psychiatric disorders Anxiety	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Psychiatric disorders Anxiety disorder	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Psychiatric disorders Completed suicide	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Psychiatric disorders Depression	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Psychiatric disorders Major depression	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Psychiatric disorders Schizophreniform disorder	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Renal and urinary disorders Acute kidney injury	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Renal and urinary disorders Calculus urinary	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Renal and urinary disorders Nephrolithiasis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Reproductive system and breast disorders Fibrocystic breast disease	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.02% 1/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Reproductive system and breast disorders Varicocele	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Asthma	0.55% 32/5868 • Number of events 34 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.53% 31/5861 • Number of events 34 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.05% 3/5868 • Number of events 3 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.07% 4/5861 • Number of events 4 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Skin and subcutaneous tissue disorders Angioedema	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 3 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Skin and subcutaneous tissue disorders Skin hypertrophy	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Skin and subcutaneous tissue disorders Urticaria	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Vascular disorders Deep vein thrombosis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Vascular disorders Hypertension	0.05% 3/5868 • Number of events 3 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Vascular disorders Varicose vein	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Acute coronary syndrome	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.

Other adverse events

Measure	MF/F MDI BID n=5868 participants at risk	MF MDI BID n=5861 participants at risk
Cardiac disorders Angina pectoris	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Arrhythmia	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Atrial fibrillation	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Vascular disorders Hypertension	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Investigations Heart rate increased	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
General disorders Chest discomfort	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.05% 3/5861 • Number of events 3 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Palpitations	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Supraventricular tachycardia	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Cardiac disorders Tachycardia	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
General disorders Non-cardiac chest pain	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Vascular disorders Hot flush	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Skin and subcutaneous tissue disorders Lichen planus	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
General disorders Feeling jittery	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Tongue discomfort	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Immune system disorders Hypersensitivity	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Laryngeal hypertrophy	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Investigations Weight increased	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Asthma	0.05% 3/5868 • Number of events 3 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Stomatitis	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.05% 3/5861 • Number of events 3 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Retching	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Bronchospasm paradoxical	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Dry mouth	0.05% 3/5868 • Number of events 3 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.07% 4/5868 • Number of events 4 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.09% 5/5861 • Number of events 5 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Influenza	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Hypopnea	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Conjunctivitis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Headache	0.05% 3/5868 • Number of events 3 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.12% 7/5861 • Number of events 7 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Immune system disorders Drug hypersensitivity	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Psychiatric disorders Insomnia	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Nausea	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.07% 4/5868 • Number of events 4 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.09% 5/5861 • Number of events 5 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Sinusitis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Tremor	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Oral candidiasis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Pharyngitis	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Laryngitis	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Candida infection	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
General disorders Asthenia	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Dysgeusia	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.05% 3/5861 • Number of events 3 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Cough	0.03% 2/5868 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.10% 6/5861 • Number of events 6 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Oral discomfort	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Psychiatric disorders Anxiety	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Skin and subcutaneous tissue disorders Pruritus	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Glossodynia	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Skin and subcutaneous tissue disorders Rash	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Oral mucosal erythema	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Abdominal pain upper	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Dizziness	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.00% 0/5861 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Musculoskeletal and connective tissue disorders Muscle spasms	0.02% 1/5868 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Immune system disorders Allergic edema	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Vocal cord disorder	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Upper respiratory tract infection	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.05% 3/5861 • Number of events 3 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Ear and labyrinth disorders Vertigo	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Bronchitis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Gastrointestinal disorders Mouth ulceration	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Nasopharyngitis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
General disorders Mucosal inflammation	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Pneumonia	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Lower respiratory tract infection	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Oral fungal infection	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Infections and infestations Oropharyngeal candidiasis	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Aphonia	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.03% 2/5861 • Number of events 2 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Nervous system disorders Epilepsy	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.
General disorders Adverse drug reaction	0.00% 0/5868 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.	0.02% 1/5861 • Number of events 1 • 26 weeks, or 7 days after the last treatment dose, whichever occurred later All serious adverse events are reported. Only those non-serious (Other) adverse events leading to treatment discontinuation were collected during the study, and are reported here.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor, and to provide the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication which report any trial results. The sponsor has the right to review and comment on publications, abstracts, slides, and manuscripts, and to review and comment on data analysis and presentation.
• Publication restrictions are in place

Restriction type: OTHER