Trial Outcomes & Findings for Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies (NCT NCT02328014)
NCT ID: NCT02328014
Last Updated: 2025-12-09
Results Overview
Best response and overall response rate per the criteria investigator uses for each disease histology. Standardized response and progression criteria is based on established criteria for B-cell malignancies, including WM (Cheson 2014; Owen 2013; Hallek 2008; Bladé 1998; and Durie 2006).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
from the start of the treatment to the last evaluable disease assessment, an average of 1 year
Results posted on
2025-12-09
Participant Flow
All data collection and Final analysis for the study has been completed. However, as we face a unique challenge in oncology studies, some patients benefiting from the medication, continue to receive treatment beyond final analysis with NO requirement for any further data collection or additional data analysis.
Participant milestones
| Measure |
Part 1 Cohort 1
Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously
|
Part 1 Cohort 2
Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
|
Part 1 Cohort 3
Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously
|
Part 2
Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
22
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
6
|
22
|
Reasons for withdrawal
| Measure |
Part 1 Cohort 1
Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously
|
Part 1 Cohort 2
Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
|
Part 1 Cohort 3
Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously
|
Part 2
Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
4
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Disease Progression
|
1
|
0
|
1
|
3
|
|
Overall Study
Study Terminated by Sponsor
|
4
|
1
|
1
|
0
|
|
Overall Study
Subject Started Another Cancer Therapy
|
0
|
5
|
4
|
12
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies
Baseline characteristics by cohort
| Measure |
Part 1 Cohort 2
n=6 Participants
Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
|
Part 1 Cohort 3
n=6 Participants
Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously
|
Part 2
n=22 Participants
Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
|
Total
n=40 Participants
Total of all reporting groups
|
Part 1 Cohort 1
n=6 Participants
Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68.0 Years
STANDARD_DEVIATION 9.9 • n=6 Participants
|
62.5 Years
STANDARD_DEVIATION 7.9 • n=9 Participants
|
68.3 Years
STANDARD_DEVIATION 9.2 • n=17 Participants
|
68.3 Years
STANDARD_DEVIATION 9.2 • n=16 Participants
|
61.2 Years
STANDARD_DEVIATION 7.3 • n=9 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
9 Participants
n=17 Participants
|
16 Participants
n=16 Participants
|
3 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
13 Participants
n=17 Participants
|
24 Participants
n=16 Participants
|
3 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
5 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
22 Participants
n=17 Participants
|
39 Participants
n=16 Participants
|
6 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=17 Participants
|
5 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
18 Participants
n=17 Participants
|
34 Participants
n=16 Participants
|
6 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
22 Participants
n=17 Participants
|
40 Participants
n=16 Participants
|
6 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: from the start of the treatment to the last evaluable disease assessment, an average of 1 yearPopulation: All-Treated Population
Best response and overall response rate per the criteria investigator uses for each disease histology. Standardized response and progression criteria is based on established criteria for B-cell malignancies, including WM (Cheson 2014; Owen 2013; Hallek 2008; Bladé 1998; and Durie 2006).
Outcome measures
| Measure |
Part 1 Cohort 1
n=6 Participants
Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously
|
Part 1 Cohort 2
n=6 Participants
Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
|
Part 1 Cohort 3
n=6 Participants
Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously
|
Part 2
n=22 Participants
Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
|
|---|---|---|---|---|
|
Best Response and Overall Response Rate
SD
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
0 percentage of participants
Interval 0.0 to 45.9
|
4.5 percentage of participants
Interval 0.1 to 22.8
|
|
Best Response and Overall Response Rate
PD
|
0 percentage of participants
Interval 0.0 to 45.9
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
0 percentage of participants
Interval 0.0 to 45.9
|
36.4 percentage of participants
Interval 17.2 to 59.3
|
|
Best Response and Overall Response Rate
Missing
|
0 percentage of participants
Interval 0.0 to 45.9
|
0 percentage of participants
Interval 0.0 to 45.9
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
0 percentage of participants
Interval 0.0 to 15.4
|
|
Best Response and Overall Response Rate
ORR (CR+VGPR+PR)
|
83.3 percentage of participants
Interval 35.9 to 99.3
|
50 percentage of participants
Interval 11.8 to 88.2
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
40.9 percentage of participants
Interval 20.7 to 63.7
|
|
Best Response and Overall Response Rate
PR
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
50 percentage of participants
Interval 11.8 to 88.2
|
50 percentage of participants
Interval 11.8 to 88.2
|
22.7 percentage of participants
Interval 7.8 to 45.4
|
|
Best Response and Overall Response Rate
CR
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
0 percentage of participants
Interval 0.0 to 45.9
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
18.2 percentage of participants
Interval 5.2 to 40.3
|
|
Best Response and Overall Response Rate
VGPR
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
0 percentage of participants
Interval 0.0 to 45.9
|
0 percentage of participants
Interval 0.0 to 45.9
|
0 percentage of participants
Interval 0.0 to 15.4
|
Adverse Events
Part 1 Cohort 3
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2
Serious events: 11 serious events
Other events: 22 other events
Deaths: 4 deaths
Part 1 Cohort 1
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1 Cohort 2
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 Cohort 3
n=6 participants at risk
Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously
|
Part 2
n=22 participants at risk
Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
|
Part 1 Cohort 1
n=6 participants at risk
Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously
|
Part 1 Cohort 2
n=6 participants at risk
Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
General disorders
Asthenia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
9.1%
2/22 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Pulmonary nocardiosis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Vascular disorders
Embolism
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
Other adverse events
| Measure |
Part 1 Cohort 3
n=6 participants at risk
Part 1 Cohort 3: ACP-196 100 mg BID + ACP-319 100 mg BID continuously
|
Part 2
n=22 participants at risk
Part 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
|
Part 1 Cohort 1
n=6 participants at risk
Part 1 Cohort 1: ACP-196 100 mg BID + ACP-319 25 mg BID continuously
|
Part 1 Cohort 2
n=6 participants at risk
Part 1 Cohort 2: ACP-196 100 mg BID + ACP-319 50 mg BID continuously
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 5 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
22.7%
5/22 • Number of events 7 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Salivary gland cyst
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
13.6%
3/22 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
General disorders
Catheter site pain
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
General disorders
Chills
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
General disorders
Fatigue
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
36.4%
8/22 • Number of events 9 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
50.0%
3/6 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
General disorders
Mass
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
General disorders
Oedema
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
General disorders
Peripheral swelling
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
18.2%
4/22 • Number of events 7 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Hepatobiliary disorders
Hepatic lesion
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Brain abscess
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
9.1%
2/22 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Chronic sinusitis
|
50.0%
3/6 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Eye infection
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Fungal disease carrier
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Hordeolum
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Influenza
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Localised infection
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Oral herpes
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Oral infection
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Pneumonia
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 4 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Pulmonary nocardiosis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Rhinitis
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Sinusitis
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Blood phosphorus decreased
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Blood pressure orthostatic decreased
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Haematocrit decreased
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Lipase increased
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Weight decreased
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
18.2%
4/22 • Number of events 4 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 4 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
13.6%
3/22 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
9.1%
2/22 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
9.1%
2/22 • Number of events 4 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 5 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Abdominal tenderness
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
9.1%
2/22 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
4/6 • Number of events 8 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
54.5%
12/22 • Number of events 20 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
83.3%
5/6 • Number of events 8 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
66.7%
4/6 • Number of events 5 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
9.1%
2/22 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
3/6 • Number of events 4 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
9.1%
2/22 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
31.8%
7/22 • Number of events 9 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Ear and labyrinth disorders
Cerumen impaction
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Endocrine disorders
Thyroid mass
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Eye disorders
Cataract nuclear
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
18.2%
4/22 • Number of events 4 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
66.7%
4/6 • Number of events 9 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
66.7%
4/6 • Number of events 8 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Infections and infestations
Urinary tract infection
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
9.1%
2/22 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Injury, poisoning and procedural complications
Contusion
|
66.7%
4/6 • Number of events 7 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
9.1%
2/22 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Injury, poisoning and procedural complications
Joint injury
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
54.5%
12/22 • Number of events 20 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
50.0%
3/6 • Number of events 9 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • Number of events 5 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
45.5%
10/22 • Number of events 14 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
50.0%
3/6 • Number of events 9 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 4 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
9.1%
2/22 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 4 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 4 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
13.6%
3/22 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
9.1%
2/22 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
2/6 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular melanoma
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
13.6%
3/22 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
66.7%
4/6 • Number of events 6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Number of events 4 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
27.3%
6/22 • Number of events 8 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
50.0%
3/6 • Number of events 4 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Hemiapraxia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Parosmia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
9.1%
2/22 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Renal and urinary disorders
Nocturia
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Renal and urinary disorders
Pollakiuria
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
4/6 • Number of events 6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
9.1%
2/22 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
13.6%
3/22 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
9.1%
2/22 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
13.6%
3/22 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
33.3%
2/6 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
18.2%
4/22 • Number of events 4 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
40.9%
9/22 • Number of events 14 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 3 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
4.5%
1/22 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/22 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
22.7%
5/22 • Number of events 6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose, an average of 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place