Trial Outcomes & Findings for Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL (NCT NCT02337829)
NCT ID: NCT02337829
Last Updated: 2026-07-21
Results Overview
The best response to treatment was determined according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria incorporating 2012 and 2013 clarifications pertaining to subjects treated with kinase inhibitors. Overall response rate (ORR) was the proportion of subjects who achieved complete response (CR), CR with incomplete marrow recovery (CRi), or partial response (PR) while on treatment before the initiation of new anti-cancer therapy or stem cell transplant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Cycle 1 (28 Days) to 6 months
Results posted on
2026-07-21
Participant Flow
Participant milestones
| Measure |
Acalabrutinib 100 mg BID Relapse/Refractory
relapsed/refractory subjects treated with acalabrutinib 100 mg twice a day
|
Acalabrutinib 200 mg QD Relapse/Refractory
Relapse/Refractory subjects treated with acalabrutinib 200 mg once a day
|
Acalabrutinib 100 mg BID Treatment Naive
Treatment naive subjects treated with acalabrutinib 100 mg twice a day
|
Acalabrutinib 200 mg QD Treatment Naive
Treatment naive subjects treated with acalabrutinib 200 mg once a day
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
14
|
6
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
18
|
14
|
6
|
10
|
Reasons for withdrawal
| Measure |
Acalabrutinib 100 mg BID Relapse/Refractory
relapsed/refractory subjects treated with acalabrutinib 100 mg twice a day
|
Acalabrutinib 200 mg QD Relapse/Refractory
Relapse/Refractory subjects treated with acalabrutinib 200 mg once a day
|
Acalabrutinib 100 mg BID Treatment Naive
Treatment naive subjects treated with acalabrutinib 100 mg twice a day
|
Acalabrutinib 200 mg QD Treatment Naive
Treatment naive subjects treated with acalabrutinib 200 mg once a day
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
|
Overall Study
Study terminated by sponsor
|
12
|
10
|
5
|
6
|
|
Overall Study
discontinued for other reasons
|
6
|
3
|
1
|
4
|
Baseline Characteristics
Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL
Baseline characteristics by cohort
| Measure |
Acalabrutinib 100 mg BID Relapse/Refractory
n=18 Participants
relapsed/refractory subjects treated with acalabrutinib 100 mg twice a day
|
Acalabrutinib 200 mg QD Relapse/Refractory
n=14 Participants
Relapse/Refractory subjects treated with acalabrutinib 200 mg once a day
|
Acalabrutinib 100 mg BID Treatment Naive
n=6 Participants
Treatment naive subjects treated with acalabrutinib 100 mg twice a day
|
Acalabrutinib 200 mg QD Treatment Naive
n=10 Participants
Treatment naive subjects treated with acalabrutinib 200 mg once a day
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.3 Years
STANDARD_DEVIATION 9.3 • n=9 Participants
|
62.3 Years
STANDARD_DEVIATION 7.7 • n=27 Participants
|
68.3 Years
STANDARD_DEVIATION 10.9 • n=267 Participants
|
62.1 Years
STANDARD_DEVIATION 8.7 • n=265 Participants
|
63.4 Years
STANDARD_DEVIATION 8.9 • n=568 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
15 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
33 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
18 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
9 Participants
n=265 Participants
|
47 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
5 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
7 Participants
n=265 Participants
|
39 Participants
n=568 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
10 Participants
n=265 Participants
|
48 Participants
n=568 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28 Days) to 6 monthsThe best response to treatment was determined according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria incorporating 2012 and 2013 clarifications pertaining to subjects treated with kinase inhibitors. Overall response rate (ORR) was the proportion of subjects who achieved complete response (CR), CR with incomplete marrow recovery (CRi), or partial response (PR) while on treatment before the initiation of new anti-cancer therapy or stem cell transplant.
Outcome measures
| Measure |
Acalabrutinib 100 mg BID Relapse/Refractory
n=18 Participants
relapsed/refractory subjects treated with acalabrutinib 100 mg twice a day
|
Acalabrutinib 200 mg QD Relapse/Refractory
n=13 Participants
Relapse/Refractory subjects treated with acalabrutinib 200 mg once a day
|
Total Relapse/Refractory Subjects
n=31 Participants
All relapse/refractory subjects in both dose groups combined
|
Acalabrutinib 100 mg BID Treatment Naive
n=6 Participants
Treatment naive subjects treated with acalabrutinib 100 mg twice a day
|
Acalabrutinib 200 mg QD Treatment Naive
n=10 Participants
Treatment naive subjects treated with acalabrutinib 200 mg once a day
|
Total Treatment Naive Subjects
n=16 Participants
All treatment naive subjects in both dose groups combined
|
|---|---|---|---|---|---|---|
|
Response Based on Overall Response Rate
|
17 Participants
|
11 Participants
|
28 Participants
|
6 Participants
|
8 Participants
|
14 Participants
|
Adverse Events
Acalabrutinib 200 mg QD Treatment Naive
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Acalabrutinib 100 mg BID Treatment Naive
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Acalabrutinib 100 mg BID Relapse/Refractory
Serious events: 11 serious events
Other events: 18 other events
Deaths: 0 deaths
Acalabrutinib 200 mg QD Relapse/Refractory
Serious events: 8 serious events
Other events: 14 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Acalabrutinib 200 mg QD Treatment Naive
n=10 participants at risk
Treatment naive subjects treated with acalabrutinib 200 mg once a day
|
Acalabrutinib 100 mg BID Treatment Naive
n=6 participants at risk
Treatment naive subjects treated with acalabrutinib 100 mg twice a day
|
Acalabrutinib 100 mg BID Relapse/Refractory
n=18 participants at risk
relapsed/refractory subjects treated with acalabrutinib 100 mg twice a day
|
Acalabrutinib 200 mg QD Relapse/Refractory
n=14 participants at risk
Relapse/Refractory subjects treated with acalabrutinib 200 mg once a day
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Enterocolitis
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Diverticulitis
|
10.0%
1/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Hepatitis b reactivation
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Lower respiratory tract infection fungal
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Skin infection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Vascular disorders
Haematoma
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
Other adverse events
| Measure |
Acalabrutinib 200 mg QD Treatment Naive
n=10 participants at risk
Treatment naive subjects treated with acalabrutinib 200 mg once a day
|
Acalabrutinib 100 mg BID Treatment Naive
n=6 participants at risk
Treatment naive subjects treated with acalabrutinib 100 mg twice a day
|
Acalabrutinib 100 mg BID Relapse/Refractory
n=18 participants at risk
relapsed/refractory subjects treated with acalabrutinib 100 mg twice a day
|
Acalabrutinib 200 mg QD Relapse/Refractory
n=14 participants at risk
Relapse/Refractory subjects treated with acalabrutinib 200 mg once a day
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Polycythaemia
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Uveitis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Angina pectoris
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Cyst
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Aortic valve disease
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Aortic valve incompetence
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Arrhythmia
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Cardiomegaly
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Blood and lymphatic system disorders
Hyperglobulinaemia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
3/6 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Palpitations
|
20.0%
2/10 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
21.4%
3/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Pericardial effusion
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Pulmonary valve disease
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Sinus bradycardia
|
20.0%
2/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Supraventricular tachycardia
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Cardiac disorders
Ventricular extrasystoles
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Ear and labyrinth disorders
Ear congestion
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Ear and labyrinth disorders
Ear discomfort
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Ear and labyrinth disorders
Vertigo
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Endocrine disorders
Adrenal mass
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Endocrine disorders
Thyroid mass
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Asthenopia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Cataract
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Conjunctival hyperaemia
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Dry eye
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Eye pain
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Keratitis
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Lenticular opacities
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Photophobia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Retinal tear
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Vitreous floaters
|
30.0%
3/10 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Abdominal hernia
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
2/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Anal fissure
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Anal incontinence
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Colitis
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Dental caries
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
4/10 • Number of events 9 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
66.7%
4/6 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
38.9%
7/18 • Number of events 12 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
7/14 • Number of events 13 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
40.0%
4/10 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Intestinal perforation
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Large intestine polyp
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • Number of events 7 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
27.8%
5/18 • Number of events 8 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
42.9%
6/14 • Number of events 7 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Poor dental condition
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
35.7%
5/14 • Number of events 6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Chest discomfort
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Chest pain
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Chills
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Facial pain
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Fatigue
|
30.0%
3/10 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
66.7%
4/6 • Number of events 6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
22.2%
4/18 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
35.7%
5/14 • Number of events 6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Feeling abnormal
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Hernia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Inflammation
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Influenza like illness
|
80.0%
8/10 • Number of events 15 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
3/6 • Number of events 6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
38.9%
7/18 • Number of events 14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
64.3%
9/14 • Number of events 15 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Injection site bruising
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Injection site pain
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Injection site reaction
|
30.0%
3/10 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Localised oedema
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Oedema
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Oedema peripheral
|
20.0%
2/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
83.3%
5/6 • Number of events 7 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
28.6%
4/14 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Pain
|
20.0%
2/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
General disorders
Pyrexia
|
40.0%
4/10 • Number of events 9 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
22.2%
4/18 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
21.4%
3/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Hepatobiliary disorders
Dilatation intrahepatic duct acquired
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Immune system disorders
Drug hypersensitivity
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Cellulitis
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
21.4%
3/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Cystitis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Erythema migrans
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Eye infection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Herpes zoster
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Herpes zoster reactivation
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Laryngitis
|
10.0%
1/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Lip infection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Localised infection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Oral candidiasis
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Otitis media
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Pneumonia
|
30.0%
3/10 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
3/6 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
22.2%
4/18 • Number of events 8 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
21.4%
3/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Skin infection
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
5/10 • Number of events 10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
3/6 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
9/18 • Number of events 13 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
42.9%
6/14 • Number of events 12 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 7 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
21.4%
3/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Viral infection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
60.0%
6/10 • Number of events 12 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
100.0%
6/6 • Number of events 11 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
61.1%
11/18 • Number of events 16 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
64.3%
9/14 • Number of events 14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
20.0%
2/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
2/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Beta 2 microglobulin increased
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Blood alkaline phosphatase
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Blood creatine phosphokinase increased
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Blood creatinine increased
|
40.0%
4/10 • Number of events 7 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Blood urea decreased
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Blood urea increased
|
30.0%
3/10 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
C-reactive protein increased
|
20.0%
2/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Cd4 lymphocytes decreased
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
3/6 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
6/18 • Number of events 7 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
28.6%
4/14 • Number of events 8 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Cardiac murmur
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Fibrin d dimer increased
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Haemoglobin increased
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Haptoglobin decreased
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
International normalised ratio increased
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
3/6 • Number of events 10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 8 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
21.4%
3/14 • Number of events 13 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
21.4%
3/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
27.8%
5/18 • Number of events 6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
42.9%
6/14 • Number of events 11 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Neutrophil count increased
|
20.0%
2/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Platelet count decreased
|
30.0%
3/10 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 7 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
22.2%
4/18 • Number of events 14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Platelet count increased
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Weight decreased
|
20.0%
2/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
28.6%
4/14 • Number of events 9 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
Weight increased
|
20.0%
2/10 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
66.7%
4/6 • Number of events 12 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
27.8%
5/18 • Number of events 13 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
21.4%
3/14 • Number of events 9 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
21.4%
3/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
30.0%
3/10 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
3/6 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
38.9%
7/18 • Number of events 10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
28.6%
4/14 • Number of events 8 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
21.4%
3/14 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
5/10 • Number of events 9 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
3/6 • Number of events 7 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
6/18 • Number of events 7 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
35.7%
5/14 • Number of events 8 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
21.4%
3/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
5/10 • Number of events 7 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
44.4%
8/18 • Number of events 10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
57.1%
8/14 • Number of events 13 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
21.4%
3/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
2/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
83.3%
5/6 • Number of events 6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Amnesia
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Dizziness
|
30.0%
3/10 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
22.2%
4/18 • Number of events 7 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
35.7%
5/14 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Headache
|
60.0%
6/10 • Number of events 11 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
83.3%
5/6 • Number of events 10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
66.7%
12/18 • Number of events 20 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
71.4%
10/14 • Number of events 15 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Memory impairment
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Meralgia paraesthetica
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Paraesthesia
|
20.0%
2/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Presyncope
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Syncope
|
30.0%
3/10 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
27.8%
5/18 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
28.6%
4/14 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Psychiatric disorders
Phonophobia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Renal and urinary disorders
Chromaturia
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Renal and urinary disorders
Chronic kidney disease
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Renal and urinary disorders
Haematuria
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Renal and urinary disorders
Pollakiuria
|
10.0%
1/10 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
3/6 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Renal and urinary disorders
Renal mass
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Reproductive system and breast disorders
Hydrometra
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
5/10 • Number of events 6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
3/6 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
9/18 • Number of events 11 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
30.0%
3/10 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
3/6 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
35.7%
5/14 • Number of events 7 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
40.0%
4/10 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
6/18 • Number of events 9 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
21.4%
3/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
3/6 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
22.2%
4/18 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
33.3%
2/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
27.8%
5/18 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
22.2%
4/18 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
21.4%
3/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
30.0%
3/10 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
21.4%
3/14 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
50.0%
5/10 • Number of events 8 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
27.8%
5/18 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
28.6%
4/14 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.0%
3/10 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.0%
4/10 • Number of events 6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
27.8%
5/18 • Number of events 7 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
57.1%
8/14 • Number of events 17 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
11.1%
2/18 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Vascular disorders
Aortic dilatation
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Vascular disorders
Fibromuscular dysplasia
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Vascular disorders
Flushing
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Vascular disorders
Haematoma
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
1/6 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
16.7%
3/18 • Number of events 3 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Vascular disorders
Hot flush
|
40.0%
4/10 • Number of events 4 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
5.6%
1/18 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • Number of events 5 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
3/6 • Number of events 8 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
55.6%
10/18 • Number of events 32 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
50.0%
7/14 • Number of events 13 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Vascular disorders
Lymphoedema
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
14.3%
2/14 • Number of events 2 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Vascular disorders
Subclavian artery occlusion
|
10.0%
1/10 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/14 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/10 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/6 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
0.00%
0/18 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
7.1%
1/14 • Number of events 1 • From first dose of study drug until 30 days post last dose for each subject; an average of approximately 38 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place