Trial Outcomes & Findings for Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAH (Zamicastat) (NCT NCT04316143)

NCT ID: NCT04316143

Last Updated: 2024-10-15

Results Overview

This PK parameters (24-hour profile) for zamicastat and its metabolites will be derived after a single dose of 50 mg zamicastat

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 33 participants
• Primary outcome timeframe: Day 1 (0 hours and then 1, 2, 4, 8, 16 and 24 hours after investigational medicinal product (IMP) intake)
• Results posted on: 2024-10-15

Participant Flow

Of 33 patients enrolled in this study, 29 patients started treatment with zamicastat (4 Screening Failures), 28 patients completed the dose finding period and entered the maintenance period (1 premature termination). Patients who had been enrolled and, for whatever reason, discontinued the study after first IMP intake at visit A1 were classified as withdrawals. Patients might withdraw from the study at any time, either on their own request or at the discretion of the investigator.

Participant milestones

Measure	50 mg Zamicastat 50 mg zamicastat once daily (half a tablet of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)	100 mg Zamicastat Once Daily 100 mg zamicastat once daily (one tablet of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)	150 mg Zamicastat Once Daily 150 mg zamicastat once daily (one and a half tablet of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)	200 mg Zamicastat Once Daily 200 mg zamicastat once daily (two tablets of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)
50 mg Toleration Period - Dose A STARTED	29	0	0	0
50 mg Toleration Period - Dose A COMPLETED	27	0	0	0
50 mg Toleration Period - Dose A NOT COMPLETED	2	0	0	0
100 mg Toleration Period - Dose B STARTED	0	27	0	0
100 mg Toleration Period - Dose B COMPLETED	0	21	0	0
100 mg Toleration Period - Dose B NOT COMPLETED	0	6	0	0
150 mg Toleration Period - Dose C STARTED	0	0	21	0
150 mg Toleration Period - Dose C COMPLETED	0	0	19	0
150 mg Toleration Period - Dose C NOT COMPLETED	0	0	2	0
200 mg Toleration Period - Dose D STARTED	0	0	0	19
200 mg Toleration Period - Dose D COMPLETED	0	0	0	19
200 mg Toleration Period - Dose D NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAH (Zamicastat)

Baseline characteristics by cohort

Measure	50 mg Zamicastat n=1 Participants 50 mg zamicastat once daily (half a tablet of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)	100 mg Zamicastat Once Daily n=6 Participants 100 mg zamicastat once daily (one tablet of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)	150 mg Zamicastat Once Daily n=2 Participants 150 mg zamicastat once daily (one and a half tablet of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)	200 mg Zamicastat Once Daily n=19 Participants 200 mg zamicastat once daily (two tablets of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	16 Participants n=4 Participants	25 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	14 Participants n=4 Participants	21 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	19 Participants n=4 Participants	28 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Height (cm) <=1.65cm	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	12 Participants n=4 Participants	13 Participants n=21 Participants
Height (cm) >1.65	1 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	15 Participants n=21 Participants
Weight (kg) <71,5kg	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	16 Participants n=4 Participants	20 Participants n=21 Participants
Weight (kg) >71,5kg	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	8 Participants n=21 Participants
BMI (kg/m2) <=25,4kg/m2	0 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants	15 Participants n=21 Participants
BMI (kg/m2) >=25,5kg/m2	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants	13 Participants n=21 Participants
Childbearing Potential Yes	0 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	11 Participants n=21 Participants
Childbearing Potential No	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants	11 Participants n=21 Participants
Childbearing Potential Not Applicable	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 1 (0 hours and then 1, 2, 4, 8, 16 and 24 hours after investigational medicinal product (IMP) intake)

Population: Following multiple administrations of the HTD of zamicastat to pulmonary arterial hypertension (PAH) patients at maintenance period visit (MPV)3, pharmacokinetic (PK) concentrations and parameter summaries for only the 50 mg, 100 mg and 200 mg dose levels are presented and discussed, as the only subject receiving the 150 mg HTD level had a major protocol deviation documented, impacting the reliability of their PK data.

This PK parameters (24-hour profile) for zamicastat and its metabolites will be derived after a single dose of 50 mg zamicastat

Outcome measures

Measure	50 mg Zamicastat n=1 Participants 50 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	100 mg Zamicastat Once Daily n=4 Participants 100 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	150 mg Zamicastat Once Daily 150 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	200 mg Zamicastat Once Daily n=17 Participants 200 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat
Area Under the Curve 0-24h (AUC0-24h) (ng.h/mL) - 50 mg Zamicastat	155 ng.h/mL	761 ng.h/mL Standard Deviation 44.6	—	1570 ng.h/mL Standard Deviation 59.7
Area Under the Curve 0-24h (AUC0-24h) (ng.h/mL) - 50 mg BIA 5-453_1	—	172 ng.h/mL	—	305 ng.h/mL Standard Deviation 38.5
Area Under the Curve 0-24h (AUC0-24h) (ng.h/mL) - 50 mg BIA 5-453_2	—	181 ng.h/mL	—	305 ng.h/mL Standard Deviation 38.5
Area Under the Curve 0-24h (AUC0-24h) (ng.h/mL) - 50 mg BIA 5-961	—	150,187 ng.h/mL Standard Deviation 0	—	277 ng.h/mL Standard Deviation 94.3

PRIMARY outcome

Timeframe: 1, 2, 4, 8, 16 and 24 hours after IMP intake

Population: Following multiple administrations of the HTD of zamicastat to PAH patients at MPV3, PK concentrations and parameter summaries for only the 50 mg, 100 mg and 200 mg dose levels are presented and discussed, as the only subject receiving the 150 mg HTD level had a major protocol deviation documented, impacting the reliability of their PK data.

This PK parameter (24-hour profile) for zamicastat and its metabolites will be derived at steady-state at the individual highest tolerated dose (HTD)

Outcome measures

Measure	50 mg Zamicastat n=1 Participants 50 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	100 mg Zamicastat Once Daily n=4 Participants 100 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	150 mg Zamicastat Once Daily 150 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	200 mg Zamicastat Once Daily n=17 Participants 200 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat
Area Under the Curve 0-24h (AUC0-24h) (ng.h/mL/mg) - HTD Zamicastat	3.09 ng.h/mL/mg	7.61 ng.h/mL/mg Standard Deviation 44.6	—	7.87 ng.h/mL/mg Standard Deviation 59.7
Area Under the Curve 0-24h (AUC0-24h) (ng.h/mL/mg) - HTD BIA 5-453_1	—	1.72 ng.h/mL/mg Standard Deviation 0	—	1.53 ng.h/mL/mg Standard Deviation 38.5
Area Under the Curve 0-24h (AUC0-24h) (ng.h/mL/mg) - HTD BIA 5-453_2	—	1.81 ng.h/mL/mg	—	1.53 ng.h/mL/mg Standard Deviation 38.5
Area Under the Curve 0-24h (AUC0-24h) (ng.h/mL/mg) - HTD BIA 5-961_1	—	1.50 ng.h/mL/mg	—	1.39 ng.h/mL/mg Standard Deviation 94.3
Area Under the Curve 0-24h (AUC0-24h) (ng.h/mL/mg) - HTD BIA 5-961_2	—	1.87 ng.h/mL/mg	—	1.39 ng.h/mL/mg Standard Deviation 94.3

PRIMARY outcome

Timeframe: Day 1 (0 hours and then 1, 2, 4, 8, 16 and 24 hours after IMP intake)

Population: Following multiple administrations of the HTD of zamicastat to PAH patients at MPV3, PK concentrations and parameter summaries for only the 50 mg, 100 mg and 200 mg dose levels are presented and discussed, as the only subject receiving the 150 mg HTD level had a major protocol deviation documented, impacting the reliability of their PK data.

This PK parameters (24-hour profile) for zamicastat and its metabolites will be derived after a single dose of 50 mg zamicastat

Outcome measures

Measure	50 mg Zamicastat n=1 Participants 50 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	100 mg Zamicastat Once Daily n=4 Participants 100 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	150 mg Zamicastat Once Daily 150 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	200 mg Zamicastat Once Daily n=17 Participants 200 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat
Maximum Plasma Concentration (Cmax) (ng/mL) - 50 mg Zamicastat	13.3 ng/mL	62.6 ng/mL Standard Deviation 60.5	—	134 ng/mL Standard Deviation 94.0
Maximum Plasma Concentration (Cmax) (ng/mL) - 50 mg 5-453	—	8.39 ng/mL Standard Deviation 33.1	—	18.8 ng/mL Standard Deviation 48.1
Maximum Plasma Concentration (Cmax) (ng/mL) - 50 mg BIA 5-961_1	5.39 ng/mL	11.0 ng/mL	—	17.6 ng/mL Standard Deviation 78.2
Maximum Plasma Concentration (Cmax) (ng/mL) - 50 mg BIA 5-961_2	5.39 ng/mL	23.9 ng/mL	—	17.6 ng/mL Standard Deviation 78.2

PRIMARY outcome

Timeframe: 1, 2, 4, 8, 16 and 24 hours after IMP intake

Population: Following multiple administrations of the HTD of zamicastat to PAH patients at MPV3, PK concentrations and parameter summaries for only the 50 mg, 100 mg and 200 mg dose levels are presented and discussed, as the only subject receiving the 150 mg HTD level had a major protocol deviation documented, impacting the reliability of their PK data.

This PK parameter (24-hour profile) for zamicastat and its metabolites will be derived at steady-state at the individual highest tolerated dose (HTD)

Outcome measures

Measure	50 mg Zamicastat n=1 Participants 50 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	100 mg Zamicastat Once Daily n=4 Participants 100 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	150 mg Zamicastat Once Daily 150 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	200 mg Zamicastat Once Daily n=17 Participants 200 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat
Maximum Plasma Concentration (Cmax) (ng/mL/mg) - HTD Zamicastat	0.27 ng/mL/mg	0.626 ng/mL/mg Standard Deviation 60.5	—	0.672 ng/mL/mg Standard Deviation 94.0
Maximum Plasma Concentration (Cmax) (ng/mL/mg) - HTD BIA 5-453	—	0.0839 ng/mL/mg Standard Deviation 33.1	—	0.0939 ng/mL/mg Standard Deviation 48.1
Maximum Plasma Concentration (Cmax) (ng/mL/mg) - HTD BIA 5-961_1	0.108 ng/mL/mg	0.110 ng/mL/mg	—	0.0882 ng/mL/mg Standard Deviation 78.2
Maximum Plasma Concentration (Cmax) (ng/mL/mg) - HTD BIA 5-961_2	0.108 ng/mL/mg	0.239 ng/mL/mg	—	0.0882 ng/mL/mg Standard Deviation 78.2

PRIMARY outcome

Timeframe: Day 1 (0 hours and then 1, 2, 4, 8, 16 and 24 hours after IMP intake)

Population: Following multiple administrations of the HTD of zamicastat to PAH patients at MPV3, PK concentrations and parameter summaries for only the 50 mg, 100 mg and 200 mg dose levels are presented and discussed, as the only subject receiving the 150 mg HTD level had a major protocol deviation documented, impacting the reliability of their PK data.

This PK parameters (24-hour profile) for zamicastat and its metabolites will be derived after a single dose of 50 mg zamicastat

Outcome measures

Measure	50 mg Zamicastat n=1 Participants 50 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	100 mg Zamicastat Once Daily n=4 Participants 100 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	150 mg Zamicastat Once Daily 150 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	200 mg Zamicastat Once Daily n=17 Participants 200 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat
Time Until Cmax (Tmax) (h) - 50 mg Zamicastat	2.00 h	3.00 h Standard Deviation 1.00	—	4.00 h Standard Deviation 1.00
Time Until Cmax (Tmax) (h) - 50 mg BIA 5-453	—	3.00 h Standard Deviation 2.00	—	4.05 h Standard Deviation 2.00
Time Until Cmax (Tmax) (h) - 50 mg BIA 5-961	4.03 h	2.00 h	—	8.00 h Standard Deviation 4.00

PRIMARY outcome

Timeframe: 1, 2, 4, 8, 16 and 24 hours after IMP intake

Population: Following multiple administrations of the HTD of zamicastat to PAH patients at MPV3, PK concentrations and parameter summaries for only the 50 mg, 100 mg and 200 mg dose levels are presented and discussed, as the only subject receiving the 150 mg HTD level had a major protocol deviation documented, impacting the reliability of their PK data.

This PK parameter (24-hour profile) for zamicastat and its metabolites will be derived at steady-state at the individual highest tolerated dose (HTD)

Outcome measures

Measure	50 mg Zamicastat n=1 Participants 50 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	100 mg Zamicastat Once Daily n=4 Participants 100 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	150 mg Zamicastat Once Daily 150 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	200 mg Zamicastat Once Daily n=17 Participants 200 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat
Time Until Cmax (Tmax) (h) - HTD Zamicastat	2.00 h	3.00 h Standard Deviation 4.08	—	4.00 h Standard Deviation 24.00
Time Until Cmax (Tmax) (h) - HTD BIA 5-453	—	3.00 h Standard Deviation 8.08	—	4.05 h Standard Deviation 24.0
Time Until Cmax (Tmax) (h) - HTD BIA 5-961	4.03 h	8.08 h	—	8.00 h Standard Deviation 24.0

PRIMARY outcome

Timeframe: 1, 2, 4, 8, 16 and 24 hours after IMP intake

Population: Non-numerical values reported in the plasma concentration data (i.e. values that are below the limit of quantification), will be treated as missing for the determination of summary statistics. This also applies to any concentrations that are defined as PK parameters (e.g. Cmin). Where less than 3 patients receive the same dose at MPV3 or there are less than 3 quantifiable concentrations at a time point or parameter, summary statistics will not be produced for this dose/visits or time point.

This PK parameter (24-hour profile) for zamicastat and its metabolites will be derived at steady-state at the individual highest tolerated dose (HTD). Following multiple administrations of the HTD of zamicastat to PAH patients at MPV3, PK concentrations and parameter summaries for only the 50 mg, 100 mg and 200 mg dose levels are presented and discussed, as the only subject receiving the 150 mg HTD level had a major protocol deviation documented, impacting the reliability of their PK data.

Outcome measures

Measure	50 mg Zamicastat n=1 Participants 50 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	100 mg Zamicastat Once Daily n=4 Participants 100 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	150 mg Zamicastat Once Daily 150 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat	200 mg Zamicastat Once Daily n=17 Participants 200 mg zamicastat once daily Oral zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat
Minimum Plasma Concentration at the End of the Dosing Interval (Cmin,SS) (ng/mL/mg) - HTD Zamicastat	—	0.186 ng/mL/mg Standard Deviation 36.7	—	0.198 ng/mL/mg Standard Deviation 74.1
Minimum Plasma Concentration at the End of the Dosing Interval (Cmin,SS) (ng/mL/mg) - HTD BIA 5-453_1	—	0.0564 ng/mL/mg	—	0.0479 ng/mL/mg Standard Deviation 48.5
Minimum Plasma Concentration at the End of the Dosing Interval (Cmin,SS) (ng/mL/mg) - HTD BIA 5-453_2	—	0.0603 ng/mL/mg	—	0.0479 ng/mL/mg Standard Deviation 48.5
Minimum Plasma Concentration at the End of the Dosing Interval (Cmin,SS) (ng/mL/mg) - HTD BIA 5-961	—	0.0896 ng/mL/mg	—	0.0503 ng/mL/mg Standard Deviation 58.6

Adverse Events

50 mg Zamicastat

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

100 mg Zamicastat Once Daily

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

150 mg Zamicastat Once Daily

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

200 mg Zamicastat Once Daily

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	50 mg Zamicastat n=29 participants at risk 50 mg zamicastat once daily (half a tablet of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)	100 mg Zamicastat Once Daily n=28 participants at risk 100 mg zamicastat once daily (one tablet of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)	150 mg Zamicastat Once Daily n=27 participants at risk 150 mg zamicastat once daily (one and a half tablet of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)	200 mg Zamicastat Once Daily n=21 participants at risk 200 mg zamicastat once daily (two tablets of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)
Product Issues Device breakage	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.

Other adverse events

Measure	50 mg Zamicastat n=29 participants at risk 50 mg zamicastat once daily (half a tablet of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)	100 mg Zamicastat Once Daily n=28 participants at risk 100 mg zamicastat once daily (one tablet of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)	150 mg Zamicastat Once Daily n=27 participants at risk 150 mg zamicastat once daily (one and a half tablet of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)	200 mg Zamicastat Once Daily n=21 participants at risk 200 mg zamicastat once daily (two tablets of 100 mg) Zamicastat: Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)
Cardiac disorders Ventricular extrasystoles	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	7.1% 2/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Cardiac disorders Sinus arrhythmia	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	7.4% 2/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Gastrointestinal disorders Nausea	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	7.4% 2/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
General disorders Fatigue	3.4% 1/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	7.4% 2/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
General disorders Feeling abnormal	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Nervous system disorders Syncope	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Skin and subcutaneous tissue disorders Rash	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Vascular disorders Hypotension	3.4% 1/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Vascular disorders Orthostatic hypotension	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Infections and infestations Nasopharyngitis	3.4% 1/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	7.1% 2/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Infections and infestations Upper respiratory tract infection	3.4% 1/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Infections and infestations Tonsillitis	3.4% 1/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Nervous system disorders Headache	6.9% 2/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Infections and infestations Herpes simplex	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Infections and infestations Gastrointestinal infection	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Infections and infestations Viral infection	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Nervous system disorders Dizziness	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	7.1% 2/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Gastrointestinal disorders Abdominal pain	3.4% 1/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
General disorders Pyrexia	3.4% 1/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Cardiac disorders Cardiovascular disorder	3.4% 1/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	3.4% 1/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Reproductive system and breast disorders Dysmenorrhoea	3.4% 1/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Nervous system disorders Presyncope	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Nervous system disorders Sleep deficit	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Gastrointestinal disorders Diarrhoea	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Gastrointestinal disorders Diverticulum	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Investigations Alanine aminotransferase increased	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Investigations Gamma-glutamyltransferase increased	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Investigations International normalised ratio abnormal	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Vascular disorders Pallor	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Psychiatric disorders Insomnia	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	7.1% 2/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Psychiatric disorders Depression	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Product Issues Device breakage	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Gastrointestinal disorders Vomiting	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Investigations Aspartate aminotransferase increased	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Investigations Blood glucose increased	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Investigations Blood iron decreased	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Renal and urinary disorders Haematuria	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Renal and urinary disorders Renal impairment	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.7% 1/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Gastrointestinal disorders Toothache	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Investigations C-reactive protein increased	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Vascular disorders Haematoma	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Psychiatric disorders Anxiety	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Hepatobiliary disorders Gallbladder polyp	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	4.8% 1/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/29 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	3.6% 1/28 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/27 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.	0.00% 0/21 • 94,5 days In the overall population, 23 (79.3%) patients experienced 94 TEAEs during the study. The overall frequency of TEAEs was comparable between patients taking 100mg (15 patients, 53.6%), 150mg (15 patients, 55.6%) and 200mg (11 patients, 52.4%) doses at onset of TEAEs, whereas the lowest frequency (10 patients, 34.5%) was observed for patients receiving 50mg. Most TEAEs (68 out of 94) were assessed as mild in intensity, 26 TEAEs were assessed as moderate in intensity. No severe TEAEs were reported.

Additional Information

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• Principal investigator is a sponsor employee
• Publication restrictions are in place

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