Trial Outcomes & Findings for Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients (NCT NCT01202591)
NCT ID: NCT01202591
Last Updated: 2016-02-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
127 participants
Primary outcome timeframe
3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
Results posted on
2016-02-11
Participant Flow
First patient was enrolled on 8 Dec 2010 and Last patient last visit was on 21 Oct 2014. Recruitment was slow, leading to concerns about the feasibility of completing enrolment. Moreover, the limited evidence of clinical activity of AZD4547 monotherapy in FGFR gastric cancer and NSCLC has resulted in a business decision to terminate enrolment.
Part A: 38 patients enrolled, 31 patients received AZD4547+exemestane; 7 patients did not receive (5 patients were not eligible, 1 patient due to patient decision, 1 patient due to "Other") Part B: 89 patients enrolled; 80 were not eligible, 9 patients received the treatment
Participant milestones
| Measure |
AZD4547 80mg bd Cont + Ex 25mg
80 mg AZD4547 BD continuous + 25 mg exemestane
|
AZD4547 40mg Cont + Ex 25mg
40 mg AZD4547 BD continuous + 25 mg exemestane
|
AZD4547 80mg bd 1w/1w + Ex 25mg
80 mg AZD4547 bd one week on/one week off + 25 mg exemestane
|
AZD4547 80mg bd 2w/1w + Ex
80 mg AZD4547 BD two week on/one week off + 25 mg exemestane
|
Part B: AZD4547 + Fulvestrant
80 mg AZD4547 BD + 500 mg Fulvestrant
|
Part B: Placebo + Fulvestrant
80mg Placebo BD + 500 mg Fulvestrant
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
12
|
9
|
5
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
2
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
11
|
7
|
5
|
4
|
Reasons for withdrawal
| Measure |
AZD4547 80mg bd Cont + Ex 25mg
80 mg AZD4547 BD continuous + 25 mg exemestane
|
AZD4547 40mg Cont + Ex 25mg
40 mg AZD4547 BD continuous + 25 mg exemestane
|
AZD4547 80mg bd 1w/1w + Ex 25mg
80 mg AZD4547 bd one week on/one week off + 25 mg exemestane
|
AZD4547 80mg bd 2w/1w + Ex
80 mg AZD4547 BD two week on/one week off + 25 mg exemestane
|
Part B: AZD4547 + Fulvestrant
80 mg AZD4547 BD + 500 mg Fulvestrant
|
Part B: Placebo + Fulvestrant
80mg Placebo BD + 500 mg Fulvestrant
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
4
|
4
|
0
|
0
|
|
Overall Study
Other reason as per investigator
|
3
|
4
|
7
|
3
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Overall Study
Objective Disease Progression
|
0
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
AZD4547 80mg bd Cont + Ex 25mg
n=5 Participants
80 mg AZD4547 bd continuous + 25 mg exemestane
|
AZD4547 40mg bd Cont + Ex 25mg
n=5 Participants
40 mg AZD4547 BD continuous + 25 mg exemestane
|
AZD4547 80mg bd 1w/1w + Ex 25mg
n=12 Participants
80 mg AZD4547 BD one week on/one week off + 25 mg exemestane
|
AZD4547 80mg bd 2w/1w + Ex 25mg
n=9 Participants
80 mg AZD4547 bd two week on/one week off + 25 mg exemestane
|
Part B: AZD4547 + Fulvestrant
n=5 Participants
80 mg AZD4547 BD + 500 mg Fulvestrant
|
Part B: Placebo + Fulvestrant
n=4 Participants
80 mg Placebo BD + 500 mg Fulvestrant
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.4 Years
STANDARD_DEVIATION 16.70 • n=5 Participants
|
61.2 Years
STANDARD_DEVIATION 9.36 • n=7 Participants
|
66.5 Years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
67.3 Years
STANDARD_DEVIATION 9.66 • n=4 Participants
|
61.0 Years
STANDARD_DEVIATION 6.82 • n=21 Participants
|
67.3 Years
STANDARD_DEVIATION 9.46 • n=10 Participants
|
64.6 Years
STANDARD_DEVIATION 10.58 • n=115 Participants
|
|
Age, Customized
< 35
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Age, Customized
35 >= - < 50
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Age, Customized
50 >= - <65
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
|
Age, Customized
>= 65
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Sex/Gender, Customized
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
40 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian (Other Than Chinese And Japanese)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Not Applicable
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
38 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).Population: All patients who receive at least one dose of study treatment (AZD4547 or exemestane)
Outcome measures
| Measure |
AZD4547 80mg bd Cont + Ex 25mg
n=5 Participants
80 mg AZD4547 BD continuous + 25 mg exemestane
|
AZD4547 40mg Cont + Ex 25mg
n=5 Participants
40 mg AZD4547 BD continuous + 25 mg exemestane
|
AZD4547 80mg bd 1w/1w + Ex 25mg
n=12 Participants
80 mg AZD4547 bd one week on/one week off + 25 mg exemestane
|
AZD4547 80mg bd 2w/1w + Ex 25mg
n=9 Participants
80 mg AZD4547 BD two week on/one week off + 25 mg exemestane
|
Part B: AZD4547 + Fulvestrant
n=5 Participants
80 mg AZD4547 BD + 500 mg Fulvestrant
|
Part B: Placebo + Fulvestrant
n=4 Participants
80mg Placebo BD + 500 mg Fulvestrant
|
|---|---|---|---|---|---|---|
|
Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)
|
5 Participants
|
5 Participants
|
12 Participants
|
9 Participants
|
5 Participants
|
2 Participants
|
Adverse Events
AZD4547 80mg bd Cont + Ex 25mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
AZD4547 40mg bd Cont + Ex 25mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
AZD4547 80mg bd 1w/1w + Ex 25mg
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
AZD4547 80mg bd 2w/1w + Ex 25mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Part B: AZD4547 + Fulvestrant
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B: Placebo + Fulvestrant
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD4547 80mg bd Cont + Ex 25mg
n=5 participants at risk
80 mg AZD4547 bd continuous + 25 mg exemestane
|
AZD4547 40mg bd Cont + Ex 25mg
n=5 participants at risk
40 mg AZD4547 BD continuous + 25 mg exemestane
|
AZD4547 80mg bd 1w/1w + Ex 25mg
n=12 participants at risk
80 mg AZD4547 BD one week on/one week off + 25 mg exemestane
|
AZD4547 80mg bd 2w/1w + Ex 25mg
n=9 participants at risk
80 mg AZD4547 bd two week on/one week off + 25 mg exemestane
|
Part B: AZD4547 + Fulvestrant
n=5 participants at risk
80 mg AZD4547 BD + 500 mg Fulvestrant
|
Part B: Placebo + Fulvestrant
n=4 participants at risk
80 mg Placebo BD + 500 mg Fulvestrant
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
OESOPHAGEAL ACHALASIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
DEVICE DEPOSIT ISSUE
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
PLEURAL INFECTION
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
TROPONIN INCREASED
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
1/4 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
VIITH NERVE PARALYSIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Vascular disorders
JUGULAR VEIN THROMBOSIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
INFLAMMATION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
ACUTE CRISIS OF PSORIASIC OLIGOARTHRITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
Other adverse events
| Measure |
AZD4547 80mg bd Cont + Ex 25mg
n=5 participants at risk
80 mg AZD4547 bd continuous + 25 mg exemestane
|
AZD4547 40mg bd Cont + Ex 25mg
n=5 participants at risk
40 mg AZD4547 BD continuous + 25 mg exemestane
|
AZD4547 80mg bd 1w/1w + Ex 25mg
n=12 participants at risk
80 mg AZD4547 BD one week on/one week off + 25 mg exemestane
|
AZD4547 80mg bd 2w/1w + Ex 25mg
n=9 participants at risk
80 mg AZD4547 bd two week on/one week off + 25 mg exemestane
|
Part B: AZD4547 + Fulvestrant
n=5 participants at risk
80 mg AZD4547 BD + 500 mg Fulvestrant
|
Part B: Placebo + Fulvestrant
n=4 participants at risk
80 mg Placebo BD + 500 mg Fulvestrant
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
MADAROSIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
16.7%
2/12 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
1/4 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
CHORIORETINOPATHY
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
DETACHMENT OF RETINAL PIGMENT EPITHELIUM
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
3/12 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
33.3%
3/9 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
DRY EYE
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
EYE DISCHARGE
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
EYE DISORDER
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
EYE IRRITATION
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
EYE PAIN
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
EYELID PAIN
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
GROWTH OF EYELASHES
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
KERATITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
LACRIMATION INCREASED
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
MACULOPATHY
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
OCULAR DISCOMFORT
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
SUBRETINAL FLUID
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
ULCERATIVE KERATITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
VISION BLURRED
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
VITREOUS FLOATERS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
ABDOMINAL MASS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
16.7%
2/12 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
22.2%
2/9 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
ABDOMINAL TENDERNESS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
CONSTIPATION
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
80.0%
4/5 • Number of events 4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
33.3%
4/12 • Number of events 4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
33.3%
3/9 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
DIARRHOEA
|
60.0%
3/5 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
3/12 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
33.3%
3/9 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
DRY MOUTH
|
80.0%
4/5 • Number of events 4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
60.0%
3/5 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
58.3%
7/12 • Number of events 7 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
55.6%
5/9 • Number of events 5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
80.0%
4/5 • Number of events 4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
FAECAL INCONTINENCE
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
GLOSSODYNIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
LIP DRY
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
MELAENA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
NAUSEA
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
3/12 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
55.6%
5/9 • Number of events 5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
1/4 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
OESOPHAGEAL SPASM
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
PARAESTHESIA ORAL
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
33.3%
4/12 • Number of events 4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
33.3%
3/9 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
TONGUE DISCOLOURATION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Gastrointestinal disorders
VOMITING
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
ASTHENIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
CRYING
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
DEVICE BREAKAGE
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
FATIGUE
|
60.0%
3/5 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
33.3%
4/12 • Number of events 4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
FIBROSIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
INJURY ASSOCIATED WITH DEVICE
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
LOCAL SWELLING
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
OEDEMA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
PYREXIA
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
CONJUNCTIVITIS
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
GINGIVITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
INFLUENZA
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
16.7%
2/12 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
LOCALISED INFECTION
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION VIRAL
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
16.7%
2/12 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
LYMPHANGITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
MASTITIS
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
NAIL INFECTION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
OESOPHAGEAL CANDIDIASIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
ORAL CANDIDIASIS
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
3/12 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
URINARY TRACT INFECTION BACTERIAL
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
URINARY TRACT INFECTION FUNGAL
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
VARICELLA
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
VULVOVAGINAL CANDIDIASIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Injury, poisoning and procedural complications
CONTUSION
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
1/4 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
BLOOD IRON DECREASED
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
BLOOD PHOSPHORUS INCREASED
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
3/12 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
BODY TEMPERATURE INCREASED
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
CARDIAC ENZYMES INCREASED
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
COLD AGGLUTININS POSITIVE
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
ELECTROCARDIOGRAM T WAVE ABNORMAL
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
INSPIRATORY CAPACITY DECREASED
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
TROPONIN T INCREASED
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
WEIGHT DECREASED
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
44.4%
4/9 • Number of events 4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
16.7%
2/12 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
1/4 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATAEMIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
33.3%
3/9 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
3/12 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
3/12 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
16.7%
2/12 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
16.7%
2/12 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
22.2%
2/9 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER METASTATIC
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC PAIN
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEURILEMMOMA BENIGN
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
AGEUSIA
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
APHASIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
DYSGEUSIA
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
50.0%
6/12 • Number of events 6 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
66.7%
6/9 • Number of events 6 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
HEADACHE
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
3/12 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
22.2%
2/9 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
HYPOKINESIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
22.2%
2/9 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
MYOCLONUS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
NEURALGIA
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
3/12 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
TREMOR
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Psychiatric disorders
DEPRESSION
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Psychiatric disorders
DEREALISATION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
16.7%
2/12 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Psychiatric disorders
SLEEP DISORDER
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Renal and urinary disorders
PROTEINURIA
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Reproductive system and breast disorders
BREAST DISORDER
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Reproductive system and breast disorders
BREAST PAIN
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Reproductive system and breast disorders
VULVOVAGINAL DRYNESS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
DRY THROAT
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
16.7%
2/12 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
60.0%
3/5 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
16.7%
2/12 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
22.2%
2/9 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
LUNG CONSOLIDATION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DISCOMFORT
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DRYNESS
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
NASAL INFLAMMATION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
1/4 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
RALES
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
RHINALGIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
100.0%
5/5 • Number of events 5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
60.0%
3/5 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
50.0%
6/12 • Number of events 6 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
55.6%
5/9 • Number of events 5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
16.7%
2/12 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
41.7%
5/12 • Number of events 5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
33.3%
3/9 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
NAIL BED BLEEDING
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
NAIL DISCOLOURATION
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
33.3%
4/12 • Number of events 4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
44.4%
4/9 • Number of events 4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
NAIL DYSTROPHY
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
ONYCHALGIA
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
22.2%
2/9 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
ONYCHOLYSIS
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
16.7%
2/12 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
33.3%
3/9 • Number of events 3 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
PAPULE
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
RASH
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
22.2%
2/9 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
16.7%
2/12 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLOURATION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
SKIN HAEMORRHAGE
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
11.1%
1/9 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
SWELLING FACE
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Vascular disorders
HOT FLUSH
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
22.2%
2/9 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Vascular disorders
HYPERTENSION
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Vascular disorders
LYMPHOEDEMA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
8.3%
1/12 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Vascular disorders
PALLOR
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
1/4 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
Cataract
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
Corneal epithelium defect
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Eye disorders
Photophobia
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
Post viral fatigue syndrome
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Infections and infestations
Rash pustular
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
Gait disturbance
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
Induration
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
Inflammation
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
Injection site rash
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
Mucosal inflammation
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
40.0%
2/5 • Number of events 2 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
General disorders
Feeling hot
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
25.0%
1/4 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/5 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/12 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/9 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
20.0%
1/5 • Number of events 1 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
0.00%
0/4 • 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60