Trial Outcomes & Findings for Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001 (NCT NCT01429064)
NCT ID: NCT01429064
Last Updated: 2017-02-20
Results Overview
Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
From first dose of study treatment up to 4 weeks after last dose of study treatment
Results posted on
2017-02-20
Participant Flow
Participants were enrolled at 17 hospitals in Europe and in the USA
Patients with response or stable disease at week 12 in ARADES 3104001 study as judged by the investigator, were allowed to continue in the ARADES-EXT 3104002 extension study.
Participant milestones
| Measure |
Patients From Arades 3104001 Dose Escalation
200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
|
Patients From Arades 3104001 Dose Expansion (200mg/Day)
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
|
Patients From Arades 3104001 Dose Expansion (400mg/Day)
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
|
Patients From Arades 3104001 Dose Expansion (1400mg/Day)
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
22
|
19
|
16
|
|
Overall Study
COMPLETED
|
19
|
22
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001
Baseline characteristics by cohort
| Measure |
Patients From Arades 3104001 Dose Escalation
n=19 Participants
200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
|
Patients From Arades 3104001 Dose Expansion (200mg/Day)
n=22 Participants
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
|
Patients From Arades 3104001 Dose Expansion (400mg/Day)
n=19 Participants
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
|
Patients From Arades 3104001 Dose Expansion (1400mg/Day)
n=16 Participants
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
66.5 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
68.9 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
74.6 years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
69.4 years
STANDARD_DEVIATION 7.3 • n=21 Participants
|
|
Gender
Female
|
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
|
|
Gender
Male
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment up to 4 weeks after last dose of study treatmentPopulation: Safety population
Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months.
Outcome measures
| Measure |
Patients From Arades 3104001 Dose Escalation
n=19 Participants
200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
|
Patients From Arades 3104001 Dose Expansion (200mg/Day)
n=22 Participants
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
|
Patients From Arades 3104001 Dose Expansion (400mg/Day)
n=19 Participants
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
|
Patients From Arades 3104001 Dose Expansion (1400mg/Day)
n=16 Participants
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
19 participants
|
22 participants
|
19 participants
|
16 participants
|
Adverse Events
Patients From Arades 3104001 Dose Escalation
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Patients From Arades 3104001 Dose Expansion (200mg/Day)
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
Patients From Arades 3104001 Dose Expansion (400mg/Day)
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Patients From Arades 3104001 Dose Expansion (1400mg/Day)
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients From Arades 3104001 Dose Escalation
n=19 participants at risk
200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
|
Patients From Arades 3104001 Dose Expansion (200mg/Day)
n=22 participants at risk
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
|
Patients From Arades 3104001 Dose Expansion (400mg/Day)
n=19 participants at risk
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
|
Patients From Arades 3104001 Dose Expansion (1400mg/Day)
n=16 participants at risk
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Ileus paralytic
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
General disorders
Chills
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
General disorders
Fatigue
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
General disorders
Pain
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
General disorders
Pyrexia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Infection
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Lung infection
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Stenotrophomonas infection
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Investigations
Enterobacter test positive
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
12.5%
2/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Cerebral ischaemia
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Urethral stenosis
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Urinary retention
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Vascular disorders
Deep vein thrombosis
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
Other adverse events
| Measure |
Patients From Arades 3104001 Dose Escalation
n=19 participants at risk
200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
|
Patients From Arades 3104001 Dose Expansion (200mg/Day)
n=22 participants at risk
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
|
Patients From Arades 3104001 Dose Expansion (400mg/Day)
n=19 participants at risk
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
|
Patients From Arades 3104001 Dose Expansion (1400mg/Day)
n=16 participants at risk
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Cardiac disorders
Ventricular extrasystoles
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Ear and labyrinth disorders
Motion sickness
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Eye disorders
Eye pain
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Eye disorders
Eye pruritus
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Eye disorders
Ocular hyperaemia
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Eye disorders
Visual acuity reduced
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Cheilitis
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Constipation
|
15.8%
3/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
13.6%
3/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
15.8%
3/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
12.5%
2/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
47.4%
9/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
18.8%
3/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Flatulence
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Nausea
|
26.3%
5/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
15.8%
3/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
18.8%
3/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Stomatitis
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
12.5%
2/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
General disorders
Asthenia
|
26.3%
5/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
General disorders
Chest pain
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
General disorders
Face oedema
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
General disorders
Fatigue
|
26.3%
5/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
13.6%
3/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
26.3%
5/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
50.0%
8/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
General disorders
Influenza like illness
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
General disorders
Localised oedema
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
General disorders
Malaise
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
General disorders
Oedema peripheral
|
15.8%
3/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
31.2%
5/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
General disorders
Pain
|
21.1%
4/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
31.8%
7/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
18.8%
3/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
General disorders
Peripheral swelling
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
General disorders
Pyrexia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Immune system disorders
Hypersensitivity
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Eye infection
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Infection
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Influenza
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Lower respiratory tract infection
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Nasopharyngitis
|
21.1%
4/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Oral herpes
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Rhinitis
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Tinea cruris
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Tooth infection
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Urinary tract infection
|
15.8%
3/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Infections and infestations
Viral infection
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
18.8%
3/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
12.5%
2/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
12.5%
2/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Injury, poisoning and procedural complications
Sunburn
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Investigations
Blood pressure increased
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Investigations
Blood urine present
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Investigations
Cardiac murmur
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Investigations
Electrocardiogram QT prolonged
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Investigations
Heart rate increased
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Investigations
Liver palpable
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Investigations
Urine output increased
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Investigations
Weight decreased
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Investigations
Weight increased
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
13.6%
3/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
26.3%
5/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
12.5%
2/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
31.6%
6/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
31.8%
7/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
15.8%
3/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
18.8%
3/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
36.8%
7/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
18.2%
4/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
26.3%
5/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
37.5%
6/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Exposed bone in jaw
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
13.6%
3/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
12.5%
2/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
12.5%
2/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
12.5%
2/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Areflexia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Dizziness
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
15.8%
3/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Headache
|
21.1%
4/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Hypoaesthesia
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Hyporeflexia
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Paraesthesia
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Presyncope
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Sciatica
|
15.8%
3/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Somnolence
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Nervous system disorders
Tremor
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Psychiatric disorders
Depression
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Psychiatric disorders
Insomnia
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
15.8%
3/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Psychiatric disorders
Sleep disorder
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Bladder dilatation
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Dysuria
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Haematuria
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
13.6%
3/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
12.5%
2/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Micturition frequency decreased
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Pollakiuria
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
12.5%
2/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Renal and urinary disorders
Urinary tract inflammation
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
15.8%
3/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Reproductive system and breast disorders
Penile oedema
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
3/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.8%
3/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
12.5%
2/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Vascular disorders
Aortic arteriosclerosis
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Vascular disorders
Flushing
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Vascular disorders
Hot flush
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
15.8%
3/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
12.5%
2/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Vascular disorders
Hypertension
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
9.1%
2/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
18.8%
3/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
4.5%
1/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Vascular disorders
Lymphoedema
|
10.5%
2/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Vascular disorders
Poor peripheral circulation
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
6.2%
1/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Vascular disorders
Superficial vein prominence
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
|
Vascular disorders
Lymphostasis
|
0.00%
0/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/22 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
5.3%
1/19 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
0.00%
0/16 • From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER