Trial Outcomes & Findings for Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food (NCT NCT00845871)

Last Updated: 2021-07-20

Results Overview

Palatability was assessed by participants based on a five-point Facial Hedonic scale defined as: dislike extremely; somewhat dislike; neither like or dislike; somewhat like; like extremely for the meal and method of administration. For participants under 5 years of age, the scale was completed by parent or caregiver.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

65 participants

Primary outcome timeframe

Week 8 and Week 12

Results posted on

2021-07-20

Participant Flow

The study was conducted at 17 centres in United States.

82 participants were screened, out of which 65 participants enrolled into study. Study design comprised of a one-month run-in period where participants took deferasirox according to the physician, followed by a three-month assessment period. In assessment period, participants were instructed to document the selected method of administration and meal (breakfast, dinner, or no meal). Method of administration and meal type were kept same over week, but allowed to change once a new week began.

Participant milestones

Participant milestones
Measure	Deferasirox Participants were administered with deferasirox starting dose of 20 milligram/kilogram/day (mg/kg/day), daily 30 minutes before meal for 4 weeks of Run-in period. Where as, Participants were administered daily with deferasirox at a minimum starting dose of 20 mg/kg/day along with different food and liquids consistently for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
Run-in Period STARTED	65
Run-in Period COMPLETED	65
Run-in Period NOT COMPLETED	0
Assessment Period STARTED	65
Assessment Period COMPLETED	58
Assessment Period NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Deferasirox Participants were administered with deferasirox starting dose of 20 milligram/kilogram/day (mg/kg/day), daily 30 minutes before meal for 4 weeks of Run-in period. Where as, Participants were administered daily with deferasirox at a minimum starting dose of 20 mg/kg/day along with different food and liquids consistently for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
Assessment Period Adverse Event	2
Assessment Period Abnormal laboratory values	1
Assessment Period Abnormal test procedure results	1
Assessment Period Patient withdrew consent	3

Baseline Characteristics

Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Deferasirox n=65 Participants Participants were administered daily with deferasirox at a minimum starting dose of 20 mg/kg/day along with different food and liquids consistently for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
Age, Continuous	27.0 years STANDARD_DEVIATION 22.88 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	26 Participants n=5 Participants
Race/Ethnicity, Customized Black	25 Participants n=5 Participants
Race/Ethnicity, Customized Asian	10 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants
Taking Exjade prior to the study Yes	44 Participants n=5 Participants
Taking Exjade prior to the study No	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 8 and Week 12

Population: The primary analysis was performed in the ITT population defined as all subjects enrolled regardless of any treatment received or not. As per the planned analysis, data were summarized by counts and percentages of each category of response when administered with food or with different methods of administration.

Outcome measures

Outcome measures
Measure	Breakfast (Deferasirox With Soft Food) n=16 Participants Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food at breakfast for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	Breakfast (Deferasirox With Liquid) n=11 Participants Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at breakfast for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	Dinner (Deferasirox With Soft Food) n=6 Participants Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food a dinner for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	Dinner (Deferasirox With Liquid) n=10 Participants Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at dinner for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	No Meal (Deferasirox With Liquid) n=40 Participants Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	No Meal Deferasirox With Soft Food) n=17 Participants Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to a soft food with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	No Meal Deferasirox With Soft Food) Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to a soft food with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.
Percentage of Participants With Differing Palatability Scores at Week 8 and Week 12 Week 8, Dislike extremely	10 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—
Percentage of Participants With Differing Palatability Scores at Week 8 and Week 12 Week 8, Somewhat dislike	0 percentage of participants	28.6 percentage of participants	0 percentage of participants	14.3 percentage of participants	5.9 percentage of participants	14.3 percentage of participants	—
Percentage of Participants With Differing Palatability Scores at Week 8 and Week 12 Week 8, Like extremely	40 percentage of participants	42.9 percentage of participants	66.7 percentage of participants	28.6 percentage of participants	47.1 percentage of participants	14.3 percentage of participants	—
Percentage of Participants With Differing Palatability Scores at Week 8 and Week 12 Week 12, Like extremely	50 percentage of participants	50 percentage of participants	33.3 percentage of participants	33.3 percentage of participants	26.1 percentage of participants	30 percentage of participants	—
Percentage of Participants With Differing Palatability Scores at Week 8 and Week 12 Week 8, Neither like or dislike	20 percentage of participants	28.6 percentage of participants	33.3 percentage of participants	28.6 percentage of participants	29.4 percentage of participants	28.6 percentage of participants	—
Percentage of Participants With Differing Palatability Scores at Week 8 and Week 12 Week 8, Somewhat like	30 percentage of participants	0 percentage of participants	0 percentage of participants	28.6 percentage of participants	17.6 percentage of participants	42.9 percentage of participants	—
Percentage of Participants With Differing Palatability Scores at Week 8 and Week 12 Week 12, Dislike extremely	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	4.3 percentage of participants	0 percentage of participants	—
Percentage of Participants With Differing Palatability Scores at Week 8 and Week 12 Week 12, Somewhat dislike	0 percentage of participants	25 percentage of participants	0 percentage of participants	0 percentage of participants	4.3 percentage of participants	10 percentage of participants	—
Percentage of Participants With Differing Palatability Scores at Week 8 and Week 12 Week 12, Neither like or dislike	16.7 percentage of participants	25 percentage of participants	0 percentage of participants	33.3 percentage of participants	56.5 percentage of participants	50 percentage of participants	—
Percentage of Participants With Differing Palatability Scores at Week 8 and Week 12 Week 12, Somewhat like	33.3 percentage of participants	0 percentage of participants	66.7 percentage of participants	33.3 percentage of participants	8.7 percentage of participants	10 percentage of participants	—

SECONDARY outcome

Timeframe: Day 1 up to Week 16

Population: The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication. As per the planned analysis, data were summarized by counts and percentages of each category of response when administered with food or with different methods of administration.

Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. Subjects who had permanently terminated from the treatment or kept the treatment on hold/deviated from protocol due to adverse event were defined as subjects with permanent discontinuation and temporary interruption, respectively.

Outcome measures

Outcome measures
Measure	Breakfast (Deferasirox With Soft Food) n=62 Participants Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food at breakfast for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	Breakfast (Deferasirox With Liquid) n=20 Participants Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at breakfast for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	Dinner (Deferasirox With Soft Food) n=18 Participants Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food a dinner for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	Dinner (Deferasirox With Liquid) n=14 Participants Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at dinner for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	No Meal (Deferasirox With Liquid) n=17 Participants Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	No Meal Deferasirox With Soft Food) n=39 Participants Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to a soft food with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	No Meal Deferasirox With Soft Food) n=30 Participants Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to a soft food with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation and Interruption SAEs	5 Participants	5 Participants	0 Participants	1 Participants	1 Participants	6 Participants	0 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation and Interruption AEs leading to permanent discontinuation	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation and Interruption AEs leading to temporary interruption	4 Participants	2 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation and Interruption AEs	39 Participants	10 Participants	6 Participants	6 Participants	6 Participants	24 Participants	11 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation and Interruption Death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose (0), 1, 2, 4 and 6 hour (post-dose) at Week 8, 12 and 16

Population: The analysis was performed in the ITT population defined as all subjects enrolled regardless of any treatment received or not. As per the planned analysis, data was summarized as overall by combining all Arms/Groups.

Blood samples were drawn at every visit as close as possible to 24 hours post dose from each subject participating in the study and trough plasma concentrations were estimated.

Outcome measures

Outcome measures
Measure	Breakfast (Deferasirox With Soft Food) n=57 Participants Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food at breakfast for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	Breakfast (Deferasirox With Liquid) Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at breakfast for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	Dinner (Deferasirox With Soft Food) Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food a dinner for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	Dinner (Deferasirox With Liquid) Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at dinner for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	No Meal (Deferasirox With Liquid) Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	No Meal Deferasirox With Soft Food) Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to a soft food with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	No Meal Deferasirox With Soft Food) Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to a soft food with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.
Trough Plasma Concentration of Deferasirox at Week 8, Week 12 and Week 16 Week 8, Deferasirox 20 mg/kg	36.30 micromoles per litre (μmol/L) Interval 0.0 to 145.0	—	—	—	—	—	—
Trough Plasma Concentration of Deferasirox at Week 8, Week 12 and Week 16 Week 12, Deferasirox 20 mg/kg	66.95 micromoles per litre (μmol/L) Interval 2.8 to 157.0	—	—	—	—	—	—
Trough Plasma Concentration of Deferasirox at Week 8, Week 12 and Week 16 Week 16, Deferasirox 20 mg/kg	27.75 micromoles per litre (μmol/L) Interval 0.0 to 200.0	—	—	—	—	—	—
Trough Plasma Concentration of Deferasirox at Week 8, Week 12 and Week 16 Week 8, Deferasirox 30 mg/kg	20.15 micromoles per litre (μmol/L) Interval 2.2 to 62.1	—	—	—	—	—	—
Trough Plasma Concentration of Deferasirox at Week 8, Week 12 and Week 16 Week 12, Deferasirox 30 mg/kg	34.30 micromoles per litre (μmol/L) Interval 0.0 to 105.0	—	—	—	—	—	—
Trough Plasma Concentration of Deferasirox at Week 8, Week 12 and Week 16 Week 16, Deferasirox 30 mg/kg	54.50 micromoles per litre (μmol/L) Interval 0.0 to 146.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16 (End of study)

Population: The analysis was performed in the ITT population. The 'n' signifies those subjects evaluable for this measure at specified time points for each group respectively. As per the planned analysis, data was summarized as overall by combining all Arms/Groups.

Ferritin protein stores iron and provides overall iron levels. Higher ferritin in blood showed higher iron content. Fluctuations from normal serum ferritin levels (500 ng/mL) observed at two consecutive visits led to dose adjustment of deferasirox.

Outcome measures

Outcome measures
Measure	Breakfast (Deferasirox With Soft Food) n=64 Participants Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food at breakfast for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	Breakfast (Deferasirox With Liquid) Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at breakfast for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	Dinner (Deferasirox With Soft Food) Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food a dinner for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	Dinner (Deferasirox With Liquid) Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at dinner for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	No Meal (Deferasirox With Liquid) Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	No Meal Deferasirox With Soft Food) Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to a soft food with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	No Meal Deferasirox With Soft Food) Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to a soft food with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.
Change From Baseline in Serum Ferritin at Week 16 Age 2 to < 10 years	-198.1 Nanogram/mlillilitre Standard Deviation 653.11	—	—	—	—	—	—
Change From Baseline in Serum Ferritin at Week 16 Age 10 to < 60 years	38.3 Nanogram/mlillilitre Standard Deviation 859.45	—	—	—	—	—	—
Change From Baseline in Serum Ferritin at Week 16 Age ≥ 60 years	-593 Nanogram/mlillilitre Standard Deviation 1683.39	—	—	—	—	—	—

Adverse Events

Deferasirox (Overall)

Serious events: 15 serious events

Other events: 52 other events

Deaths: 0 deaths

Deferasirox (Run-in Phase)

Serious events: 5 serious events

Other events: 30 other events

Deaths: 0 deaths

Breakfast (Deferasirox With Soft Food)

Serious events: 5 serious events

Other events: 10 other events

Deaths: 0 deaths

Breakfast (Deferasirox With Liquid)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Dinner (Deferasirox With Soft Food)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Dinner (Deferasirox With Liquid)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

No Meal (Deferasirox With Liquid)

Serious events: 6 serious events

Other events: 18 other events

Deaths: 0 deaths

No Meal (Deferasirox With Soft Food)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Deferasirox (Overall) n=65 participants at risk Participants were administered daily with deferasirox at a minimum starting dose of 20 mg/kg/day along with different food and liquids consistently for 12 weeks of assessment period. For subjects receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	Deferasirox (Run-in Phase) n=62 participants at risk Participants were administered with deferasirox starting dose of 20 milligram/kilogram/day (mg/kg/day), daily 30 minutes before meal.	Breakfast (Deferasirox With Soft Food) n=20 participants at risk Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food at breakfast for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	Breakfast (Deferasirox With Liquid) n=18 participants at risk Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at breakfast for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	Dinner (Deferasirox With Soft Food) n=14 participants at risk Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food a dinner for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	Dinner (Deferasirox With Liquid) n=17 participants at risk Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at dinner for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	No Meal (Deferasirox With Liquid) n=39 participants at risk Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	No Meal (Deferasirox With Soft Food) n=30 participants at risk Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to a soft food with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.
Infections and infestations Viral infection	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Blood and lymphatic system disorders Acute chest syndrome	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	1.6% 1/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Congenital, familial and genetic disorders Sickle cell anaemia with crisis	12.3% 8/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	4.8% 3/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.9% 1/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	12.8% 5/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Gastrointestinal disorders Pancreatitis acute	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	1.6% 1/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
General disorders Catheter related complication	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
General disorders Pyrexia	4.6% 3/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	1.6% 1/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	2.6% 1/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Hepatobiliary disorders Cholelithiasis	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	1.6% 1/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Infections and infestations Influenza	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	2.6% 1/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Infections and infestations Perirectal abscess	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	7.1% 1/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Infections and infestations Pneumonia	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	1.6% 1/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Infections and infestations Sepsis	3.1% 2/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	10.0% 2/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	7.1% 1/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Vascular disorders Hypotension	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	7.1% 1/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.

Other adverse events

Other adverse events
Measure	Deferasirox (Overall) n=65 participants at risk Participants were administered daily with deferasirox at a minimum starting dose of 20 mg/kg/day along with different food and liquids consistently for 12 weeks of assessment period. For subjects receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	Deferasirox (Run-in Phase) n=62 participants at risk Participants were administered with deferasirox starting dose of 20 milligram/kilogram/day (mg/kg/day), daily 30 minutes before meal.	Breakfast (Deferasirox With Soft Food) n=20 participants at risk Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food at breakfast for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	Breakfast (Deferasirox With Liquid) n=18 participants at risk Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at breakfast for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	Dinner (Deferasirox With Soft Food) n=14 participants at risk Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to soft food a dinner for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.	Dinner (Deferasirox With Liquid) n=17 participants at risk Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at dinner for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	No Meal (Deferasirox With Liquid) n=39 participants at risk Participants received deferasirox at a minimum starting dose of 20 mg/kg/day dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.	No Meal (Deferasirox With Soft Food) n=30 participants at risk Participants received crushed deferasirox at a minimum starting dose of 20 mg/kg/day added to a soft food with no meal for 12 weeks of assessment period. For participants receiving \> 30 mg/kg/ day, a maximum of 40 mg/kg/day was allowed.
Renal and urinary disorders Proteinuria	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Metabolism and nutrition disorders Anorexia	6.2% 4/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	4.8% 3/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	2.6% 1/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Blood and lymphatic system disorders Thrombocytopenia	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Cardiac disorders Palpitations	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Eye disorders Ocular icterus	4.6% 3/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	1.6% 1/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.1% 2/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Eye disorders Photophobia	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Gastrointestinal disorders Abdominal distension	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	7.1% 1/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain	12.3% 8/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	9.7% 6/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	11.1% 2/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	14.3% 2/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	2.6% 1/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	3.3% 1/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain upper	12.3% 8/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	3.2% 2/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	7.1% 1/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.9% 1/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.1% 2/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	10.0% 3/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Gastrointestinal disorders Constipation	3.1% 2/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	1.6% 1/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.9% 1/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	30.8% 20/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	24.2% 15/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	7.1% 1/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.1% 2/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	6.7% 2/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Gastrointestinal disorders Gastrointestinal hypermotility	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Gastrointestinal disorders Nausea	23.1% 15/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	14.5% 9/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	14.3% 2/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.9% 1/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	7.7% 3/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Gastrointestinal disorders Vomiting	15.4% 10/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	6.5% 4/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	7.1% 1/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.1% 2/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	6.7% 2/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
General disorders Asthenia	4.6% 3/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	1.6% 1/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	2.6% 1/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
General disorders Catheter site pain	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
General disorders Chest discomfort	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
General disorders Chest pain	3.1% 2/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	3.3% 1/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
General disorders Exercise tolerance decreased	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
General disorders Fatigue	12.3% 8/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	3.2% 2/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	11.1% 2/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	14.3% 2/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	2.6% 1/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
General disorders Oedema peripheral	4.6% 3/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	2.6% 1/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
General disorders Pyrexia	23.1% 15/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	11.3% 7/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	10.0% 2/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	21.4% 3/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	10.3% 4/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	3.3% 1/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Investigations Blood creatinine increased	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Immune system disorders Hypersensitivity	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Infections and infestations Bronchiolitis	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	7.1% 1/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Infections and infestations Otitis media	3.1% 2/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	1.6% 1/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Infections and infestations Upper respiratory tract infection	12.3% 8/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	3.2% 2/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.9% 1/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	12.8% 5/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	3.3% 1/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Infections and infestations Urinary tract infection	3.1% 2/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	1.6% 1/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Injury, poisoning and procedural complications Arthropod bite	4.6% 3/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	11.1% 2/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	2.6% 1/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Injury, poisoning and procedural complications Contusion	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Investigations Alanine aminotransferase increased	6.2% 4/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	3.2% 2/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.9% 1/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Investigations Aspartate aminotransferase increased	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Investigations Blood pressure diastolic decreased	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Investigations Urine output decreased	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Investigations Urine protein/creatinine ratio increased	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	3.1% 2/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	1.6% 1/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	7.1% 1/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Metabolism and nutrition disorders Hypomagnesaemia	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	4.6% 3/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	10.0% 2/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	3.3% 1/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Renal and urinary disorders Pollakiuria	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	6.2% 4/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	7.1% 1/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.1% 2/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	3.3% 1/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Bone lesion	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Groin pain	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Neck pain	3.1% 2/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	2.6% 1/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 5/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	1.6% 1/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	10.0% 2/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.1% 2/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Nervous system disorders Dizziness	3.1% 2/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	11.1% 2/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Nervous system disorders Headache	10.8% 7/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	8.1% 5/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	10.0% 2/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	11.1% 2/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	2.6% 1/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	3.3% 1/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Nervous system disorders Migraine	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.9% 1/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Nervous system disorders Paraesthesia	3.1% 2/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	10.0% 2/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Psychiatric disorders Insomnia	4.6% 3/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.1% 2/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Asthma	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	7.1% 1/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	9.2% 6/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	3.2% 2/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	10.0% 2/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	7.1% 1/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.9% 1/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.6% 3/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	1.6% 1/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	2.6% 1/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.7% 5/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	1.6% 1/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	10.0% 2/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.1% 2/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.1% 2/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Wheezing	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Decubitus ulcer	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	7.1% 1/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Ecchymosis	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Eczema	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.0% 1/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	3.1% 2/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	2.6% 1/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Skin irritation	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	1.6% 1/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.9% 1/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Urticaria	1.5% 1/65 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/62 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/20 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	5.6% 1/18 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/14 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/17 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/39 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.	0.00% 0/30 • First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), up to 16 weeks The analysis was performed in the Safety Set (SAF) population, defined as all participants who received at least one dose of study medication.

Additional Information

Study Director

Novartis pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place