Trial Outcomes & Findings for Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors (NCT NCT03597022)
NCT ID: NCT03597022
Last Updated: 2020-11-30
Results Overview
An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs occurring after the first administration of study drug and up to and including 30 days after the last administration of study drug were defined as treatment-emergent AEs (TEAEs). Drug-related TEAEs were TEAEs that had "reasonable causal relationship" to the study treatment decided by the investigators.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
Results posted on
2020-11-30
Participant Flow
Study was conducted at multiple centers in 11 countries or regions between 24 July 2018 (first subject first visit) and 15 October 2019 (last subject last visit).
Overall, 26 participants were screened. Of them, 1 participant was screen failure and 1 participant could not start subsequent treatment on schedule; 24 participants received study treatment.
Participant milestones
| Measure |
BAY1093884 100mg
Subjects received BAY1093884 100 mg once a week until premature termination of the study
|
BAY1093884 225mg
Subjects received BAY1093884 225 mg once a week until premature termination of the study
|
BAY1093884 400mg
Subjects received BAY1093884 400mg once a week until premature termination of the study
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
8
|
Reasons for withdrawal
| Measure |
BAY1093884 100mg
Subjects received BAY1093884 100 mg once a week until premature termination of the study
|
BAY1093884 225mg
Subjects received BAY1093884 225 mg once a week until premature termination of the study
|
BAY1093884 400mg
Subjects received BAY1093884 400mg once a week until premature termination of the study
|
|---|---|---|---|
|
Overall Study
Premature termination of the study
|
7
|
7
|
8
|
|
Overall Study
Serious adverse event
|
1
|
1
|
0
|
Baseline Characteristics
Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors
Baseline characteristics by cohort
| Measure |
BAY1093884 100mg
n=8 Participants
Subjects received BAY1093884 100 mg once a week until premature termination of the study
|
BAY1093884 225mg
n=8 Participants
Subjects received BAY1093884 225 mg once a week until premature termination of the study
|
BAY1093884 400mg
n=8 Participants
Subjects received BAY1093884 400mg once a week until premature termination of the study
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 15.6 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 daysPopulation: Safety analysis set (SAF): all participants with at least one intake of study drug
An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a participant in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs occurring after the first administration of study drug and up to and including 30 days after the last administration of study drug were defined as treatment-emergent AEs (TEAEs). Drug-related TEAEs were TEAEs that had "reasonable causal relationship" to the study treatment decided by the investigators.
Outcome measures
| Measure |
BAY1093884 100mg
n=8 Participants
Subjects received BAY1093884 100 mg once a week until premature termination of the study
|
BAY1093884 225mg
n=8 Participants
Subjects received BAY1093884 225 mg once a week until premature termination of the study
|
BAY1093884 400mg
n=8 Participants
Subjects received BAY1093884 400mg once a week until premature termination of the study
|
|---|---|---|---|
|
Number of Participants With Drug-related Treatment-emergent Adverse Events
|
1 Participants
|
4 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 daysPopulation: Safety analysis set (SAF): all participants with at least one intake of study drug
A serious adverse event (SAE) was any untoward medical occurrence that at any dose was resulting in death, was lifethreatening, requires hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity. SAEs occurring after the first administration of study drug and up to and including 30 days after the last administration of study drug were defined as serious treatment-emergent AEs (TESAEs). Drug-related TESAEs were TESAEs that had "reasonable causal relationship" to the study treatment decided by the investigators.
Outcome measures
| Measure |
BAY1093884 100mg
n=8 Participants
Subjects received BAY1093884 100 mg once a week until premature termination of the study
|
BAY1093884 225mg
n=8 Participants
Subjects received BAY1093884 225 mg once a week until premature termination of the study
|
BAY1093884 400mg
n=8 Participants
Subjects received BAY1093884 400mg once a week until premature termination of the study
|
|---|---|---|---|
|
Number of Participants With Serious Treatment-emergent Adverse Events
TESAEs
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Serious Treatment-emergent Adverse Events
Drug-related TESAEs
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 daysPopulation: Safety analysis set (SAF): all participants with at least one intake of study drug
Any thromboembolic or thrombotic microangiopathic event or any hypersensitivity reaction was an adverse event of special interest (AESI). AESIs occurring after the first administration of study drug and up to and including 30 days after the last administration of study drug were defined as treatment-emergent AESIs.
Outcome measures
| Measure |
BAY1093884 100mg
n=8 Participants
Subjects received BAY1093884 100 mg once a week until premature termination of the study
|
BAY1093884 225mg
n=8 Participants
Subjects received BAY1093884 225 mg once a week until premature termination of the study
|
BAY1093884 400mg
n=8 Participants
Subjects received BAY1093884 400mg once a week until premature termination of the study
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events of Special Interest
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 daysPopulation: Safety analysis set (SAF): all participants with at least one intake of study drug
"Clinically relevant "implied the presence of a clinical sign or symptom that required medical action.
Outcome measures
| Measure |
BAY1093884 100mg
n=8 Participants
Subjects received BAY1093884 100 mg once a week until premature termination of the study
|
BAY1093884 225mg
n=8 Participants
Subjects received BAY1093884 225 mg once a week until premature termination of the study
|
BAY1093884 400mg
n=8 Participants
Subjects received BAY1093884 400mg once a week until premature termination of the study
|
|---|---|---|---|
|
Number of Participants With Clinically Relevant Abnormalities in Laboratory Values
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
BAY1093884 100mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
BAY1093884 225mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
BAY1093884 400mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BAY1093884 100mg
n=8 participants at risk
Subjects received BAY1093884 100 mg once a week until premature termination of the study
|
BAY1093884 225mg
n=8 participants at risk
Subjects received BAY1093884 225 mg once a week until premature termination of the study
|
BAY1093884 400mg
n=8 participants at risk
Subjects received BAY1093884 400 mg once a week until premature termination of the study
|
|---|---|---|---|
|
Eye disorders
Retinal artery thrombosis
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paranasal sinus neoplasm
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Nervous system disorders
Transverse sinus thrombosis
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
Other adverse events
| Measure |
BAY1093884 100mg
n=8 participants at risk
Subjects received BAY1093884 100 mg once a week until premature termination of the study
|
BAY1093884 225mg
n=8 participants at risk
Subjects received BAY1093884 225 mg once a week until premature termination of the study
|
BAY1093884 400mg
n=8 participants at risk
Subjects received BAY1093884 400 mg once a week until premature termination of the study
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hypofibrinogenaemia
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 2 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
25.0%
2/8 • Number of events 2 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 2 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Eye disorders
Photopsia
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Gastrointestinal disorders
Tooth development disorder
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Gastrointestinal disorders
Perianal erythema
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 2 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
General disorders
Influenza like illness
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
General disorders
Injection site bruising
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
General disorders
Injection site erythema
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
25.0%
2/8 • Number of events 19 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
General disorders
Injection site inflammation
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
General disorders
Injection site pruritus
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
25.0%
2/8 • Number of events 9 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
General disorders
Injection site reaction
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 26 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
General disorders
Application site inflammation
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
General disorders
Injection site swelling
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Infections and infestations
Cellulitis
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Infections and infestations
Ear infection
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Infections and infestations
Labyrinthitis
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Infections and infestations
Nasopharyngitis
|
62.5%
5/8 • Number of events 5 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • Number of events 2 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Injury, poisoning and procedural complications
Muscle strain
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Injury, poisoning and procedural complications
Bone contusion
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Investigations
Fibrin D dimer increased
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 2 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
25.0%
2/8 • Number of events 2 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
25.0%
2/8 • Number of events 4 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
25.0%
2/8 • Number of events 3 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paranasal sinus neoplasm
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
25.0%
2/8 • Number of events 3 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
25.0%
2/8 • Number of events 3 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hypoaesthesia
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 2 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Surgical and medical procedures
Tooth extraction
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
|
Vascular disorders
Haematoma
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
12.5%
1/8 • Number of events 1 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
0.00%
0/8 • After the first administration of study drug and up to and including 30 days after the last administration of study drug, with an average of 183 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER