Trial Outcomes & Findings for Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC (NCT NCT03780010)
NCT ID: NCT03780010
Last Updated: 2019-10-28
Results Overview
Incidence of treatment-emergent (i.e. TRC105, bevacizumab, paclitaxel and/or carboplatin) adverse events by CTCAE v4.03
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
from screening until completion of follow-up, on average 6 months
Results posted on
2019-10-28
Participant Flow
medical clinic
Participant milestones
| Measure |
8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
Dose Level 1: 8 mg/kg TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC
|
10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
Dose Level 2: 10 mg/kg TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
12
|
|
Overall Study
COMPLETED
|
3
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC
Baseline characteristics by cohort
| Measure |
8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
n=3 Participants
Dose Level 1: 8 mg/kg of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
|
10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
n=12 Participants
Dose Level 2: 10 mg/kg of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
70 years
n=7 Participants
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
12 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Number of prior regimens
|
0 number of prior regimens
n=5 Participants
|
0 number of prior regimens
n=7 Participants
|
0 number of prior regimens
n=5 Participants
|
PRIMARY outcome
Timeframe: from screening until completion of follow-up, on average 6 monthsPopulation: All patients who received at least a portion of a dose of any study drug (TRC105, Bevacizumab or Paclitaxel/Carboplatin)
Incidence of treatment-emergent (i.e. TRC105, bevacizumab, paclitaxel and/or carboplatin) adverse events by CTCAE v4.03
Outcome measures
| Measure |
8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
n=3 Participants
Dose level 1: 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
|
10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
n=12 Participants
Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
|
|---|---|---|
|
Treatment-Emergent Adverse Events
Participants who experienced an AE
|
3 Participants
|
12 Participants
|
|
Treatment-Emergent Adverse Events
Participants who experienced a TRC105 related AE
|
3 Participants
|
11 Participants
|
|
Treatment-Emergent Adverse Events
Participants who experienced a Bev related AE
|
3 Participants
|
10 Participants
|
|
Treatment-Emergent Adverse Events
Participants who experienced a Carbo related AE
|
3 Participants
|
12 Participants
|
|
Treatment-Emergent Adverse Events
Participants who experienced a Pac related AE
|
3 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Number of patients with a baseline scan and at least 1 on study scan were evaluable for response rate determination
Response rate determined according to RECIST 1.1 criteria
Outcome measures
| Measure |
8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
n=3 Participants
Dose level 1: 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
|
10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
n=12 Participants
Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
|
|---|---|---|
|
Overall RECIST 1.1 Response Rate
Stable Disease Best Response
|
2 Participants
|
9 Participants
|
|
Overall RECIST 1.1 Response Rate
Partial Response Best Response
|
1 Participants
|
3 Participants
|
|
Overall RECIST 1.1 Response Rate
Progressive Disease Best Response
|
0 Participants
|
0 Participants
|
|
Overall RECIST 1.1 Response Rate
Complete Response Best Response
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Number of patients progression free according to RECIST 1.1 after 6 months of treatment
Number of patients with progression-free survival at 6 months determined according to RECIST 1.1 criteria
Outcome measures
| Measure |
8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
n=3 Participants
Dose level 1: 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
|
10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
n=10 Participants
Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
|
|---|---|---|
|
Percent of Patients With Progression-free Survival (PFS) at 6 Months
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: monthsPopulation: Number of patients progression free according to RECIST 1.1 after 6 months of treatment
Median duration of progression free survival according to RECIST 1.1 criteria
Outcome measures
| Measure |
8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
n=3 Participants
Dose level 1: 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
|
10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
n=10 Participants
Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
|
|---|---|---|
|
Median Progression Free Survival
|
3 Months
Standard Deviation 1.73
|
6.5 Months
Standard Deviation 3.35
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All patients who received at least a portion of a dose of TRC105 with PK samples collected at baseline and at least 1 time point on study
Trough serum TRC105 pharmacokinetic concentrations at steady state (cycle 3 day 1) will be measured using validated ELISA methods.
Outcome measures
| Measure |
8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
n=3 Participants
Dose level 1: 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
|
10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
n=12 Participants
Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
|
|---|---|---|
|
Pharmacokinetic Profile of TRC105 When Given With Bevacizumab and Paclitaxel/Carboplatin
|
56600 ng/mL
Interval 52000.0 to 65800.0
|
103228 ng/mL
Interval 3780.0 to 211000.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All patients who received at least a portion of a dose of TRC105 with immunogenicity samples collected at baseline and at least 1 time point on study
Anti-product antibody concentrations will be measured using validated ELISA methods. Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles.
Outcome measures
| Measure |
8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
n=3 Participants
Dose level 1: 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
|
10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
n=11 Participants
Dose level 2: 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin
|
|---|---|---|
|
Number of Patients Who Have TRC105 Positive Anti-Product Antibodies
Ptn with low titer treatment emergent ADA
|
0 Participants
|
1 Participants
|
|
Number of Patients Who Have TRC105 Positive Anti-Product Antibodies
Ptn without treatment emergent ADA
|
3 Participants
|
10 Participants
|
Adverse Events
TRC105 (0.00-0.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
Serious events: 3 serious events
Other events: 15 other events
Deaths: 1 deaths
TRC105 (1.00-1.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TRC105 (2.00-2.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
TRC105 (3.0-3.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TRC105 (4.0-4.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TRC105 (5.0-5.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
TRC105 (6.00-6.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
TRC105 (7.00-7.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
TRC105 (8.00-8.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
TRC105 (9.00-9.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
TRC105 (10.00 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TRC105 (0.00-0.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=15 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 0.00-0.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (1.00-1.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=1 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 1.00-1.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (2.00-2.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=12 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 2.00-2.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (3.0-3.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=5 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 3.00-3.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (4.0-4.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=6 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 4.00-4.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (5.0-5.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=9 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 5.00-5.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (6.00-6.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=5 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 6.00-6.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (7.00-7.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=5 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 7.0-7.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (8.00-8.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=5 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 8.0-8.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (9.00-9.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=2 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 9.0-9.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (10.00 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=1 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 at a dosage of 10.00 mg/kg at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Hematemesis
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Non Cardiac Chest Pain
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Hypertensive Encephalopathy
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Psychiatric disorders
Altered Mental Status
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Left arm wound infection
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Injury, poisoning and procedural complications
Left forearm wound/degloving injury
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Febrile Neutropenic Sepsis
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Weakness
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
Other adverse events
| Measure |
TRC105 (0.00-0.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=15 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 0.00-0.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (1.00-1.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=1 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 1.00-1.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (2.00-2.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=12 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 2.00-2.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (3.0-3.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=5 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 3.00-3.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (4.0-4.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=6 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 4.00-4.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (5.0-5.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=9 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 5.00-5.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (6.00-6.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=5 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 6.00-6.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (7.00-7.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=5 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 7.0-7.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (8.00-8.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=5 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 8.0-8.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (9.00-9.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=2 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 in the 9.0-9.99 mg/kg dosage range at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
TRC105 (10.00 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin
n=1 participants at risk
Treatment-naive patients with stage IV non-squamous NSCLC receiving TRC105 at a dosage of 10.00 mg/kg at the time of the event in combination with standard dose bevacizumab and paclitaxel/carboplatin.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness upon rising
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Intermittent left lower quadrant abdominal pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Intermittent Diarrhea
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Abdominal Cramps
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Injury, poisoning and procedural complications
Abrasions arms and face
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Acneform rash, scalp
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Acneiform rash, face
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Immune system disorders
Allergy symptoms, sneezing
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
50.0%
3/6 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
33.3%
3/9 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Anal hemorrhage
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
22.2%
2/9 • Number of events 13 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
60.0%
3/5 • Number of events 4 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Ankle edema
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
3/15 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
16.7%
2/12 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
22.2%
2/9 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 4 • From screening until completion of follow-up, on average 6 months
|
60.0%
3/5 • Number of events 6 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.7%
4/15 • Number of events 8 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
33.3%
2/6 • Number of events 4 • From screening until completion of follow-up, on average 6 months
|
22.2%
2/9 • Number of events 12 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 7 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia Knees
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgias
|
26.7%
4/15 • Number of events 7 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 12 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Psychiatric disorders
Auditory Hallucinations
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Belching
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Bilateral Ankle edema
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Bladder infection
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Bleeding gums
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Bleeding hemorrhoids
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Blood in sputum
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Blood with sinus drainage
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Central chest pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chest Congestion
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Chest Pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Chest Pain non cardiac
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Chills
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Cold intolerance
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Cold Sores
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Cold Symptoms
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Psychiatric disorders
Confusion
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
100.0%
2/2 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Constipation intermittent
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 4 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Cramps Extremities
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Investigations
Decreased Platelet Count
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15 • Number of events 4 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
41.7%
5/12 • Number of events 6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
33.3%
3/9 • Number of events 9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
60.0%
3/5 • Number of events 10 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Diarrhea, Intermittent
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Eye disorders
Dry Eyes
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin, Face
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Dry, hyperpigmented skin - posterior neck
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Dysgeusia
|
33.3%
5/15 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
33.3%
2/6 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
60.0%
3/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Renal and urinary disorders
Dysuria
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Ear and labyrinth disorders
Earache
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Investigations
Elevated TSH
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Emesis
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
33.3%
2/6 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 7 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
16.7%
2/12 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
44.4%
4/9 • Number of events 9 • From screening until completion of follow-up, on average 6 months
|
60.0%
3/5 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 8 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Erythema, palms
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Erythematous Rash, both hands
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Eye disorders
Eye floaters
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Facial Cellulitis
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Facial Numbness
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Fatigue
|
33.3%
5/15 • Number of events 6 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
25.0%
3/12 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
50.0%
3/6 • Number of events 6 • From screening until completion of follow-up, on average 6 months
|
33.3%
3/9 • Number of events 15 • From screening until completion of follow-up, on average 6 months
|
60.0%
3/5 • Number of events 8 • From screening until completion of follow-up, on average 6 months
|
60.0%
3/5 • Number of events 13 • From screening until completion of follow-up, on average 6 months
|
100.0%
5/5 • Number of events 31 • From screening until completion of follow-up, on average 6 months
|
100.0%
2/2 • Number of events 11 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Flu like symptoms
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Vascular disorders
Flushing
|
13.3%
2/15 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Generalized weakness
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Gingival Ulcer
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Gum Bleeding
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Hair Loss
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Hand tremors
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Headache
|
20.0%
3/15 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
50.0%
6/12 • Number of events 7 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
33.3%
2/6 • Number of events 4 • From screening until completion of follow-up, on average 6 months
|
22.2%
2/9 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 22 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 14 • From screening until completion of follow-up, on average 6 months
|
100.0%
2/2 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemic Respiratory Failure
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Increased Phlegm
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Injury, poisoning and procedural complications
Infusion Reaction
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Cardiac disorders
Intermittent atrial fibrillation
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Intermittent Constipation
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Intermittent Cough
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Vascular disorders
Intermittent Hypotension
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Intermittent headaches
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Intermittent shortness of breath
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Cardiac disorders
Intermittent tachycardia
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
IV infiltration during pre-med Emend administration
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Jaw Pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Left Ankle Swelling
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Left arm pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Injury, poisoning and procedural complications
Left forearm wound
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Left hand edema
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Left lower leg pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Left shoulder pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Leg weakness
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Loose bowel movement
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Metabolism and nutrition disorders
Loss of appetite
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Lower Extremity Edema
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Macropopular rash, bilateral arms
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Memory impairment
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Migraine
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
22.2%
2/9 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Mouth pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Mouth Soreness
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Musositis
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
100.0%
2/2 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
53.3%
8/15 • Number of events 10 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
16.7%
2/12 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 6 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
33.3%
2/6 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Nausea
|
60.0%
9/15 • Number of events 10 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
60.0%
3/5 • Number of events 4 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
22.2%
2/9 • Number of events 7 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
60.0%
3/5 • Number of events 4 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Neck Spasms
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Neuropathy
|
13.3%
2/15 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
3/6 • Number of events 4 • From screening until completion of follow-up, on average 6 months
|
22.2%
2/9 • Number of events 6 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 8 • From screening until completion of follow-up, on average 6 months
|
60.0%
3/5 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Neuropathy, fingers
|
13.3%
2/15 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Neuropathy, feet
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Non cardiac chest pain
|
13.3%
2/15 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nose bleed
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nose pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Cardiac disorders
Occasional Palpitations
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Oral Pain
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 4 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain arm, leg, back
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain, back
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain beneath right shoulder blade
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain, bilateral legs
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain, L hip
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain, right hand
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Pain, right posterior chest
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain, neck
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Paresthesia
|
13.3%
2/15 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Renal and urinary disorders
Patchy perfusion of the kidneys
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Injury, poisoning and procedural complications
Pathological pelvic fracture
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Pedal Edema
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Perineal cyst rupture
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Periodontal Disease
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Vascular disorders
Phlebitis, left arm
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Vascular disorders
Phlebitis, right arm
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Pleurex catheter site irritation
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
22.2%
2/9 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Rectal Bleeding
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Redness, right hand
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Redness, groin
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Respiratory cold symptoms
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Restless leg
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Psychiatric disorders
Restlessness
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Right ankle edema
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Right chest discomfort
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Right flank pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Right hand tremors
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Right knee pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Reproductive system and breast disorders
Right pelvic pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Right shoulder pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
RUQ Tenderness
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Short term memory loss
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
22.2%
2/9 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
80.0%
4/5 • Number of events 8 • From screening until completion of follow-up, on average 6 months
|
100.0%
2/2 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Drainage
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Skin infection from perianal cyst
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Skin infection left lower leg
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Sleepiness
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Sore mouth
|
20.0%
3/15 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 4 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
5/15 • Number of events 7 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
60.0%
3/5 • Number of events 7 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Swelling/fullness to left supraclavicular area
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Musculoskeletal and connective tissue disorders
Swelling, ankles
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Swelling right eyebrow area
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Cardiac disorders
Tachycardia
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Taste disturbances
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
60.0%
3/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 5 • From screening until completion of follow-up, on average 6 months
|
80.0%
4/5 • Number of events 8 • From screening until completion of follow-up, on average 6 months
|
100.0%
2/2 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Nervous system disorders
Temporal headache
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
22.2%
2/9 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Vascular disorders
Thromboembolic event (DVT)
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
100.0%
1/1 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Tooth infection
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Tooth pain
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
11.1%
1/9 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Ulceration, right corner of mouth
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Injury, poisoning and procedural complications
Upper arm lacerations
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Reproductive system and breast disorders
Vaginal Bleeding
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
16.7%
1/6 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Reproductive system and breast disorders
Vaginal Tenderness
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Eye disorders
Visual Disturbance
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Skin and subcutaneous tissue disorders
Warty scalp lesion
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Weakness
|
6.7%
1/15 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Investigations
Weight loss
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 3 • From screening until completion of follow-up, on average 6 months
|
40.0%
2/5 • Number of events 2 • From screening until completion of follow-up, on average 6 months
|
50.0%
1/2 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Gastrointestinal disorders
Worsening GERD
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
8.3%
1/12 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
General disorders
Wound dehiscence port area
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
|
Infections and infestations
Wound infection port area
|
0.00%
0/15 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/12 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/6 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/9 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
20.0%
1/5 • Number of events 1 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/5 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/2 • From screening until completion of follow-up, on average 6 months
|
0.00%
0/1 • From screening until completion of follow-up, on average 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place