Trial Outcomes & Findings for PF-06741086 Multiple Dose Study in Severe Hemophilia (NCT NCT02974855)
NCT ID: NCT02974855
Last Updated: 2019-12-04
Results Overview
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Severe TEAEs were TEAEs that interfered significantly with participants' usual function. Treatment-related TEAEs were determined by the investigator.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Study Day 1 to Day 113 Visit
Results posted on
2019-12-04
Participant Flow
A total of 27 participants were enrolled in the study and assigned to 1 of 4 cohorts. Only 26 participants received the study treatment and 1 participant withdrew after randomization but prior to dosing.
Participant milestones
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
6
|
7
|
|
Overall Study
COMPLETED
|
7
|
5
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
Baseline Characteristics
PF-06741086 Multiple Dose Study in Severe Hemophilia
Baseline characteristics by cohort
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
31.9 Years
STANDARD_DEVIATION 8.17 • n=5 Participants
|
28.7 Years
STANDARD_DEVIATION 8.31 • n=7 Participants
|
41.7 Years
STANDARD_DEVIATION 15.87 • n=5 Participants
|
44.1 Years
STANDARD_DEVIATION 9.44 • n=4 Participants
|
36.7 Years
STANDARD_DEVIATION 12.05 • n=21 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
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
26 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Study Day 1 to Day 113 VisitPopulation: The analysis population included all participants who received at least 1 dose of investigational product.
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Severe TEAEs were TEAEs that interfered significantly with participants' usual function. Treatment-related TEAEs were determined by the investigator.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
All-causalities Grade 3 or 4 TEAE
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Treatment-related Grade 3 or 4 TEAE
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
All-causalities TEAE
|
7 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
11 Participants
|
21 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Treatment-related TEAE
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
14 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
All-causalities serious TEAE
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Treatment-related serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Study Day 1 to Day 113 VisitPopulation: The analysis population included all participants who received at least 1 dose of investigational product.
An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Number of Participants Discontinued From Study Due to TEAEs
All-causalities TEAE
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Discontinued From Study Due to TEAEs
Treatment-related TEAE
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline to Study Day 113 VisitPopulation: This analysis population included all participants who received at least 1 dose of investigational product.
Hematology evaluation included: hemoglobin, hematocrit, erythrocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Predefined criteria for hemoglobin and hematocrit: \<0.8\*lower limit of normal (LLN) or \<0.8\*Baseline(Baseline \<1.0\*LLN); for platelets: \<100,000\*10\^3/mm\^3 or \<= 0.77\*Baseline (Baseline \<1.0\*LLN).
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Findings-Hematology
Hematocrit meeting pre-defined criteria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Hematology
Leukocytes <0.6*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Hematology
Lymphocytes <0.8*LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Hematology
Neutrophils >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Hematology
Basophils >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Hematology
Eosinophils >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Hematology
Monocytes >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Hematology
Hemoglobin meeting pre-defined criteria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Hematology
Erythrocytes <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Hematology
Platelets meeting pre-defined criteria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Hematology
Leukocytes >1.5*upper limit of normal (ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Hematology
Lymphocytes >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Hematology
Neutrophils <0.8*LLN
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline to Study Day 113Population: This analysis population included all participants who received at least 1 dose of investigational product. Number analyzed refers to number of participants evaluable for specified rows.
Clinical chemistry evaluation included bilirubin, direct and indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, troponin I, cholesterol and fibrinogen.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Bilirubin >1.5*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Indirect Bilirubin >1.5*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Aspartate Aminotransferase >3.0*ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Albumin <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Albumin >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Urea Nitrogen >1.3*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Creatinine >1.3*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Sodium <0.95*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Sodium >1.05*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Chloride <0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Fibrinogen <=0.5*LLN or <=0.5*baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Direct Bilirubin >1.5*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Alanine Aminotransferase >3.0*ULN
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Gamma Glutamyl Transferase >3.0*ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Alkaline Phosphatase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Protein <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Protein >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Urate >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Triglycerides >1.3*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Potassium <0.9*LLN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Potassium >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Chloride >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Calcium <0.9*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Calcium >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Bicarbonate <0.9*LLN
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Bicarbonate >1.1*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Glucose <0.6*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Glucose >1.5*ULN
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Creatine Kinase >2.0*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Troponin I >1.0*ULN
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Cholesterol >1.3*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to Study Day 113 VisitPopulation: This analysis population included all participants who received at least 1 dose of investigational product. Number analyzed refers to number of participants evaluable for specified rows.
Urinalysis included: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes, urine leukocytes and bacteria.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Findings-Urinalysis
Urobilinogen >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Urinalysis
pH (Scalar) <4.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Urinalysis
pH (Scalar) >8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Urinalysis
Urine glucose >=1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Urinalysis
Ketones (Scalar) >=1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Urinalysis
Urine protein >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Urinalysis
Urine hemoglobin (Scalar) >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Urinalysis
Urine bilirubin (Scalar) >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Urinalysis
Nitrite (Scalar) >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Urinalysis
Leukocyte esterase (Scalar) >=1
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Urinalysis
Urine erythrocytes (/HPF) >=20
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Urinalysis
Urine leukocytes (/HPF) >=20
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Laboratory Findings-Urinalysis
Bacteria (/HPF) >20
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.Population: This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number analyzed refers to number of participants evaluable for specified rows of time points.
Blood samples were obtained to determine globulin level in serum, total globulin was derived as total protein other than albumin.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline for Globulin by Dose Cohort
Globulin, Change at Day 15
|
-0.7 gram/liter
Standard Deviation 2.06
|
-0.8 gram/liter
Standard Deviation 2.32
|
-1.3 gram/liter
Standard Deviation 2.50
|
-1.3 gram/liter
Standard Deviation 3.35
|
-1.0 gram/liter
Standard Deviation 2.69
|
-1.0 gram/liter
Standard Deviation 2.47
|
|
Change From Baseline for Globulin by Dose Cohort
Globulin, Change at Day 57
|
0.7 gram/liter
Standard Deviation 3.72
|
1.8 gram/liter
Standard Deviation 2.99
|
-0.3 gram/liter
Standard Deviation 1.63
|
-0.7 gram/liter
Standard Deviation 2.94
|
0.0 gram/liter
Standard Deviation 3.28
|
0.4 gram/liter
Standard Deviation 2.90
|
|
Change From Baseline for Globulin by Dose Cohort
Globulin, Change at Day 85
|
1.3 gram/liter
Standard Deviation 3.15
|
-1.4 gram/liter
Standard Deviation 4.77
|
-0.5 gram/liter
Standard Deviation 3.02
|
1.0 gram/liter
Standard Deviation 2.61
|
1.2 gram/liter
Standard Deviation 2.79
|
0.2 gram/liter
Standard Deviation 3.35
|
|
Change From Baseline for Globulin by Dose Cohort
Globulin, Change at Day 113
|
-0.3 gram/liter
Standard Deviation 3.15
|
-1.2 gram/liter
Standard Deviation 4.67
|
0.5 gram/liter
Standard Deviation 2.65
|
-0.8 gram/liter
Standard Deviation 3.06
|
-0.5 gram/liter
Standard Deviation 2.99
|
-0.5 gram/liter
Standard Deviation 3.33
|
|
Change From Baseline for Globulin by Dose Cohort
Globulin, Change at Day 8
|
-0.3 gram/liter
Standard Deviation 3.04
|
-1.7 gram/liter
Standard Deviation 3.93
|
-1.3 gram/liter
Standard Deviation 2.73
|
0.4 gram/liter
Standard Deviation 2.51
|
0.1 gram/liter
Standard Deviation 2.70
|
-0.7 gram/liter
Standard Deviation 3.01
|
|
Change From Baseline for Globulin by Dose Cohort
Globulin, Study Day 22
|
-1.6 gram/liter
Standard Deviation 2.82
|
-0.5 gram/liter
Standard Deviation 1.52
|
-1.5 gram/liter
Standard Deviation 3.08
|
-0.6 gram/liter
Standard Deviation 4.12
|
-1.1 gram/liter
Standard Deviation 3.43
|
-1.0 gram/liter
Standard Deviation 2.93
|
|
Change From Baseline for Globulin by Dose Cohort
Globulin, Change at Day 29
|
-0.3 gram/liter
Standard Deviation 3.27
|
-0.3 gram/liter
Standard Deviation 3.08
|
0.2 gram/liter
Standard Deviation 1.10
|
-1.3 gram/liter
Standard Deviation 2.75
|
-0.8 gram/liter
Standard Deviation 2.91
|
-0.5 gram/liter
Standard Deviation 2.62
|
PRIMARY outcome
Timeframe: Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.Population: This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number analyzed refers to number of participants evaluable for specified rows of time points.
Blood samples were obtained to evaluate this ratio. The prothrombin time (PT) is a test that helps evaluate your ability to appropriately form blood clots. The international normalized ratio (INR) is a calculation based on results of a PT that is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin (Coumadin®).
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline for Prothrombin International Normalized Ratio (PT/INR) by Dose Cohort
PT/INR, Change at Day 22
|
0.03 Ratio
Standard Deviation 0.095
|
0.00 Ratio
Standard Deviation 0.063
|
-0.02 Ratio
Standard Deviation 0.041
|
-0.01 Ratio
Standard Deviation 0.069
|
0.01 Ratio
Standard Deviation 0.083
|
0.00 Ratio
Standard Deviation 0.069
|
|
Change From Baseline for Prothrombin International Normalized Ratio (PT/INR) by Dose Cohort
PT/INR, Change at Day 29
|
0.03 Ratio
Standard Deviation 0.082
|
-0.02 Ratio
Standard Deviation 0.041
|
0.00 Ratio
Standard Deviation 0.063
|
0.00 Ratio
Standard Deviation 0.115
|
0.02 Ratio
Standard Deviation 0.099
|
0.00 Ratio
Standard Deviation 0.079
|
|
Change From Baseline for Prothrombin International Normalized Ratio (PT/INR) by Dose Cohort
PT/INR, Change at Day 85
|
-0.01 Ratio
Standard Deviation 0.107
|
0.04 Ratio
Standard Deviation 0.152
|
-0.02 Ratio
Standard Deviation 0.075
|
-0.03 Ratio
Standard Deviation 0.082
|
-0.02 Ratio
Standard Deviation 0.093
|
-0.01 Ratio
Standard Deviation 0.102
|
|
Change From Baseline for Prothrombin International Normalized Ratio (PT/INR) by Dose Cohort
PT/INR, Change at Day 113
|
0.06 Ratio
Standard Deviation 0.127
|
-0.03 Ratio
Standard Deviation 0.052
|
-0.05 Ratio
Standard Deviation 0.058
|
0.07 Ratio
Standard Deviation 0.052
|
0.06 Ratio
Standard Deviation 0.096
|
0.02 Ratio
Standard Deviation 0.094
|
|
Change From Baseline for Prothrombin International Normalized Ratio (PT/INR) by Dose Cohort
PT/INR, Change at Day 8
|
-0.03 Ratio
Standard Deviation 0.049
|
-0.02 Ratio
Standard Deviation 0.041
|
0.05 Ratio
Standard Deviation 0.138
|
0.03 Ratio
Standard Deviation 0.138
|
0.00 Ratio
Standard Deviation 0.104
|
0.01 Ratio
Standard Deviation 0.102
|
|
Change From Baseline for Prothrombin International Normalized Ratio (PT/INR) by Dose Cohort
PT/INR, Change at Day 15
|
0.03 Ratio
Standard Deviation 0.076
|
0.00 Ratio
Standard Deviation 0.063
|
0.02 Ratio
Standard Deviation 0.041
|
0.00 Ratio
Standard Deviation 0.082
|
0.01 Ratio
Standard Deviation 0.077
|
0.01 Ratio
Standard Deviation 0.065
|
|
Change From Baseline for Prothrombin International Normalized Ratio (PT/INR) by Dose Cohort
PT/INR, Change at Day 57
|
0.00 Ratio
Standard Deviation 0.126
|
-0.03 Ratio
Standard Deviation 0.052
|
0.00 Ratio
Standard Deviation 0.063
|
-0.02 Ratio
Standard Deviation 0.075
|
-0.01 Ratio
Standard Deviation 0.100
|
-0.01 Ratio
Standard Deviation 0.080
|
PRIMARY outcome
Timeframe: Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.Population: This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number analyzed refers to number of participants evaluable for specified rows of time points.
The activated partial thromboplastin time (aPTT) is a screening test that helps evaluate a person's ability to appropriately form blood clots. It measures the number of seconds it takes for a clot to form in a sample of blood after substances (reagents) are added. Blood sample were obtained to evaluate aPTT.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) by Dose Cohort
aPTT, Change at Day 15
|
9.50 seconds
Standard Deviation 10.907
|
12.50 seconds
Standard Deviation 15.303
|
1.20 seconds
Standard Deviation 20.075
|
-10.26 seconds
Standard Deviation 6.757
|
-0.38 seconds
Standard Deviation 13.457
|
2.96 seconds
Standard Deviation 15.825
|
|
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) by Dose Cohort
aPTT, Change at Day 29
|
13.42 seconds
Standard Deviation 11.102
|
9.85 seconds
Standard Deviation 15.999
|
10.13 seconds
Standard Deviation 10.250
|
-12.87 seconds
Standard Deviation 11.390
|
-0.74 seconds
Standard Deviation 17.386
|
4.41 seconds
Standard Deviation 16.009
|
|
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) by Dose Cohort
aPTT, Change at Day 22
|
14.79 seconds
Standard Deviation 10.799
|
12.15 seconds
Standard Deviation 15.232
|
4.50 seconds
Standard Deviation 9.765
|
-11.77 seconds
Standard Deviation 11.247
|
1.51 seconds
Standard Deviation 17.381
|
4.65 seconds
Standard Deviation 15.543
|
|
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) by Dose Cohort
aPTT, Change at Day 57
|
13.65 seconds
Standard Deviation 13.378
|
14.25 seconds
Standard Deviation 14.061
|
7.82 seconds
Standard Deviation 11.580
|
-9.13 seconds
Standard Deviation 8.390
|
2.26 seconds
Standard Deviation 15.966
|
6.65 seconds
Standard Deviation 14.817
|
|
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) by Dose Cohort
aPTT, Change at Day 85
|
9.00 seconds
Standard Deviation 10.928
|
3.84 seconds
Standard Deviation 18.089
|
7.68 seconds
Standard Deviation 14.733
|
-7.57 seconds
Standard Deviation 10.124
|
1.35 seconds
Standard Deviation 13.278
|
3.45 seconds
Standard Deviation 14.257
|
|
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) by Dose Cohort
aPTT, Change at Day 113
|
8.46 seconds
Standard Deviation 23.391
|
0.78 seconds
Standard Deviation 16.332
|
-0.97 seconds
Standard Deviation 26.633
|
9.37 seconds
Standard Deviation 20.265
|
8.88 seconds
Standard Deviation 21.093
|
5.05 seconds
Standard Deviation 20.500
|
|
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) by Dose Cohort
aPTT, Change at Day 8
|
8.49 seconds
Standard Deviation 17.017
|
10.63 seconds
Standard Deviation 11.634
|
11.03 seconds
Standard Deviation 15.467
|
-12.26 seconds
Standard Deviation 7.082
|
-1.89 seconds
Standard Deviation 16.512
|
3.98 seconds
Standard Deviation 16.079
|
PRIMARY outcome
Timeframe: Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.Population: This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number analyzed refers to number of participants evaluable for specified rows of time points.
Fibrinogen is a protein, specifically a clotting factor (factor I), that is essential for proper blood clot formation. Blood samples were obtained to evaluate the amount of fibrinogen.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline for Fibrinogen by Dose Cohort
Fibrinogen, Change at Day 8
|
-49.7 milligram/deciliter
Standard Deviation 28.72
|
-59.7 milligram/deciliter
Standard Deviation 38.20
|
-3.5 milligram/deciliter
Standard Deviation 24.16
|
-54.4 milligram/deciliter
Standard Deviation 59.58
|
-52.1 milligram/deciliter
Standard Deviation 45.00
|
-42.6 milligram/deciliter
Standard Deviation 44.14
|
|
Change From Baseline for Fibrinogen by Dose Cohort
Fibrinogen, Change at Day 15
|
-59.4 milligram/deciliter
Standard Deviation 41.28
|
-51.0 milligram/deciliter
Standard Deviation 31.84
|
-8.3 milligram/deciliter
Standard Deviation 25.96
|
-85.6 milligram/deciliter
Standard Deviation 94.86
|
-72.5 milligram/deciliter
Standard Deviation 71.58
|
-52.7 milligram/deciliter
Standard Deviation 60.78
|
|
Change From Baseline for Fibrinogen by Dose Cohort
Fibrinogen, Change at Day 22
|
-72.0 milligram/deciliter
Standard Deviation 40.76
|
-36.8 milligram/deciliter
Standard Deviation 44.93
|
-33.2 milligram/deciliter
Standard Deviation 32.41
|
-87.9 milligram/deciliter
Standard Deviation 115.49
|
-79.9 milligram/deciliter
Standard Deviation 83.61
|
-59.2 milligram/deciliter
Standard Deviation 69.08
|
|
Change From Baseline for Fibrinogen by Dose Cohort
Fibrinogen, Change at Day 29
|
-84.7 milligram/deciliter
Standard Deviation 43.53
|
-40.0 milligram/deciliter
Standard Deviation 26.57
|
-40.3 milligram/deciliter
Standard Deviation 20.99
|
-99.9 milligram/deciliter
Standard Deviation 106.59
|
-92.8 milligram/deciliter
Standard Deviation 80.82
|
-67.6 milligram/deciliter
Standard Deviation 65.01
|
|
Change From Baseline for Fibrinogen by Dose Cohort
Fibrinogen, Change at Day 57
|
-33.5 milligram/deciliter
Standard Deviation 85.81
|
10.0 milligram/deciliter
Standard Deviation 79.34
|
-21.3 milligram/deciliter
Standard Deviation 24.23
|
-58.7 milligram/deciliter
Standard Deviation 71.81
|
-46.1 milligram/deciliter
Standard Deviation 76.57
|
-25.9 milligram/deciliter
Standard Deviation 69.68
|
|
Change From Baseline for Fibrinogen by Dose Cohort
Fibrinogen, Change at Day 85
|
-49.9 milligram/deciliter
Standard Deviation 47.93
|
-39.4 milligram/deciliter
Standard Deviation 63.27
|
-10.5 milligram/deciliter
Standard Deviation 44.94
|
-40.8 milligram/deciliter
Standard Deviation 74.28
|
-45.7 milligram/deciliter
Standard Deviation 58.91
|
-35.6 milligram/deciliter
Standard Deviation 56.31
|
|
Change From Baseline for Fibrinogen by Dose Cohort
Fibrinogen, Change at Day 113
|
-38.6 milligram/deciliter
Standard Deviation 44.48
|
-5.2 milligram/deciliter
Standard Deviation 29.34
|
23.5 milligram/deciliter
Standard Deviation 26.80
|
-61.7 milligram/deciliter
Standard Deviation 126.18
|
-49.2 milligram/deciliter
Standard Deviation 88.13
|
-25.1 milligram/deciliter
Standard Deviation 73.56
|
PRIMARY outcome
Timeframe: Baseline, Study Day 8, 15, 22 and 29.Population: This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number analyzed refers to number of participants evaluable for specified rows of time points.
Antithrombin (AT) is a protein produced by the liver that helps regulate blood clot formation (i.e., a naturally-occurring mild blood thinner). Blood samples were collected to measure the activity (function) and the amount (quantity) of antithrombin in an individual's blood is used to evaluate the person for excessive blood clotting.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline for Antithrombin III by Dose Cohort
Antithrombin III, Change at Day 22
|
-7.6 Percentage of activity of AT in plasma
Standard Deviation 17.55
|
5.2 Percentage of activity of AT in plasma
Standard Deviation 12.69
|
-5.3 Percentage of activity of AT in plasma
Standard Deviation 9.97
|
-4.4 Percentage of activity of AT in plasma
Standard Deviation 17.61
|
-6.0 Percentage of activity of AT in plasma
Standard Deviation 16.97
|
-3.3 Percentage of activity of AT in plasma
Standard Deviation 14.97
|
|
Change From Baseline for Antithrombin III by Dose Cohort
Antithrombin III, Change at Day 29
|
-0.8 Percentage of activity of AT in plasma
Standard Deviation 8.04
|
-4.3 Percentage of activity of AT in plasma
Standard Deviation 11.55
|
-10.3 Percentage of activity of AT in plasma
Standard Deviation 15.45
|
-12.7 Percentage of activity of AT in plasma
Standard Deviation 12.96
|
-7.2 Percentage of activity of AT in plasma
Standard Deviation 12.20
|
-7.3 Percentage of activity of AT in plasma
Standard Deviation 12.51
|
|
Change From Baseline for Antithrombin III by Dose Cohort
Antithrombin III, Change at Day 8
|
2.1 Percentage of activity of AT in plasma
Standard Deviation 5.18
|
-1.8 Percentage of activity of AT in plasma
Standard Deviation 7.05
|
3.7 Percentage of activity of AT in plasma
Standard Deviation 7.58
|
-7.3 Percentage of activity of AT in plasma
Standard Deviation 9.32
|
-2.6 Percentage of activity of AT in plasma
Standard Deviation 8.74
|
-1.0 Percentage of activity of AT in plasma
Standard Deviation 8.24
|
|
Change From Baseline for Antithrombin III by Dose Cohort
Antithrombin III, Change at Day 15
|
2.4 Percentage of activity of AT in plasma
Standard Deviation 16.96
|
0.5 Percentage of activity of AT in plasma
Standard Deviation 8.14
|
-15.3 Percentage of activity of AT in plasma
Standard Deviation 16.45
|
-6.9 Percentage of activity of AT in plasma
Standard Deviation 6.74
|
-2.2 Percentage of activity of AT in plasma
Standard Deviation 13.30
|
-4.6 Percentage of activity of AT in plasma
Standard Deviation 14.02
|
PRIMARY outcome
Timeframe: Baseline, Study Day 8, 15, 22, 29, 57 and 85.Population: This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number analyzed refers to number of participants evaluable for specified rows of time points.
Blood samples were collected to measure the level of cardiac-specific troponin I in the blood to help detect heart injury.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline for Troponin I by Dose Cohort
Troponin I, Change at Day 8
|
0 nanogram/milliliter
Standard Deviation 0
|
0 nanogram/milliliter
Standard Deviation 0
|
0 nanogram/milliliter
Standard Deviation 0
|
0 nanogram/milliliter
Standard Deviation 0
|
0 nanogram/milliliter
Standard Deviation 0
|
0 nanogram/milliliter
Standard Deviation 0
|
|
Change From Baseline for Troponin I by Dose Cohort
Troponin I, Change at Day 29
|
0 nanogram/milliliter
Standard Deviation 0
|
0.0113 nanogram/milliliter
Standard Deviation 0.02250
|
0 nanogram/milliliter
Standard Deviation 0
|
0.0121 nanogram/milliliter
Standard Deviation 0.03213
|
0.0065 nanogram/milliliter
Standard Deviation 0.02357
|
0.0059 nanogram/milliliter
Standard Deviation 0.02010
|
|
Change From Baseline for Troponin I by Dose Cohort
Troponin I, Change at Day 57
|
—
|
0 nanogram/milliliter
|
—
|
—
|
—
|
0 nanogram/milliliter
|
|
Change From Baseline for Troponin I by Dose Cohort
Troponin I, Change at Day 15
|
0 nanogram/milliliter
Standard Deviation 0
|
0 nanogram/milliliter
Standard Deviation 0
|
0 nanogram/milliliter
Standard Deviation 0
|
0 nanogram/milliliter
Standard Deviation 0
|
0 nanogram/milliliter
Standard Deviation 0
|
0 nanogram/milliliter
Standard Deviation 0
|
|
Change From Baseline for Troponin I by Dose Cohort
Troponin I, Change at Day 22
|
0.0042 nanogram/milliliter
Standard Deviation 0.01021
|
0 nanogram/milliliter
Standard Deviation 0
|
0 nanogram/milliliter
Standard Deviation 0
|
0.0142 nanogram/milliliter
Standard Deviation 0.03470
|
0.0092 nanogram/milliliter
Standard Deviation 0.02494
|
0.0052 nanogram/milliliter
Standard Deviation 0.01907
|
|
Change From Baseline for Troponin I by Dose Cohort
Troponin I, Change at Day 85
|
0 nanogram/milliliter
|
—
|
—
|
—
|
0 nanogram/milliliter
|
0 nanogram/milliliter
|
PRIMARY outcome
Timeframe: Baseline to Study Day 113 VisitPopulation: This analysis population included all participants who received at least 1 dose of investigational product.
Criteria for potentially clinically important findings in vital signs data were defined as: 1) supine systolic blood pressure (BP): value \<90 mm Hg or change \>=30 mm Hg increase; 2) Supine diastolic BP: value \<50 mm Hg or change \>=20 mm Hg increase; 3) Supine pulse rate: value \<40 beats/min or \>120 beats/min.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Supine diastolic BP value <50 mm Hg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Supine systolic BP value <90 mm Hg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Supine systolic BP change >=30 mm Hg increase
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Supine diastolic BP change >=20 mm Hg increase
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Supine pulse rate value <40 beats/min
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Supine pulse rate value >120 beats/min
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to Study Day 29 Visit.Population: This analysis population included all participants who received at least 1 dose of investigational product.
Criteria for potentially clinically important changes in ECG were defined as: PR interval baseline \>200 msec and increase of \>=25%; PR interval baseline \<=200 msec and increase of \>=50%; QRS interval increase of \>=50%. Only the number of participants meeting pre-defined criteria was reported below.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Change Meeting Pre-specified Criteria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to Study Day 113 VisitPopulation: This analysis population included all participants who received at least 1 dose of investigational product.
Physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Clinical significance was judged by the investigator.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Physical Examination Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to Study Day 113 VisitPopulation: This analysis population included all participants who received at least 1 dose of investigational product.
Infusion and injection site reactions included: injection site bruising, injection site erythema, injection site haemorrhage, injection site induration, injection site pain, injection site pruritus, injection site swelling and injection site warmth. Grade of severity was defined as follows: Mild: Transient or mild discomfort (\< 48 hours); no medical intervention/therapy required. Moderate: Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Infusion and Injection Site Reactions
All-causality Mild
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Infusion and Injection Site Reactions
Treatment-related Mild
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Infusion and Injection Site Reactions
All-causality Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Infusion and Injection Site Reactions
Treatment-related Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Infusion and Injection Site Reactions
All-causality Severe
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Infusion and Injection Site Reactions
Treatment-related Severe
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment: within 6 months prior to study enrollment; On-study: Day 1 to 9 days after the last dose (Day 78)Population: This efficacy analysis was conducted in the Per Protocol Analysis Set (PPAS) that included all participants who received at least 1 dose of investigational product and did not have any major protocol deviations.
Pre-treatment ABR = number of bleeding episodes within 6 months prior to study enrollment (total number of bleeding episodes in hemophilia history CRF) × 2; On-study ABR = number of bleeding episodes occurred within 9 days after the last dose / (\[last dose date + 9 - first dose date + 1\] / 365.25) The historical On Demand group was constructed using the following internal Pfizer studies: ReFacto AF 3082B2-4432 (B1831004), BeneFIX B1821010, and BeneFIX 3090A1-400 (B1821004). Participants who were on On Demand treatment in B1831004, as well as data from the On Demand period in B1821004 and B1821010 were used to construct the historical On Demand group. The resulting dataset were further filtered to match the key inclusion/exclusion criteria of Study B7841002 based on age and factor activity (18 \<=age \<=65 and factor activity \<=1%).
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=6 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=12 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=24 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Annualized Bleeding Rate (ABR)
Pre-Treatment
|
23.00 Bleeding episodes per year
Standard Deviation 7.457
|
14.67 Bleeding episodes per year
Standard Deviation 1.633
|
20.33 Bleeding episodes per year
Standard Deviation 10.838
|
17.33 Bleeding episodes per year
Standard Deviation 3.011
|
20.17 Bleeding episodes per year
Standard Deviation 6.177
|
18.83 Bleeding episodes per year
Standard Deviation 7.100
|
|
Annualized Bleeding Rate (ABR)
On-Study
|
4.22 Bleeding episodes per year
Standard Deviation 3.799
|
1.62 Bleeding episodes per year
Standard Deviation 2.533
|
4.17 Bleeding episodes per year
Standard Deviation 6.467
|
0.65 Bleeding episodes per year
Standard Deviation 1.603
|
2.43 Bleeding episodes per year
Standard Deviation 3.345
|
2.67 Bleeding episodes per year
Standard Deviation 4.092
|
SECONDARY outcome
Timeframe: pre-dose on Study Day 1, 24hours (h), 72h post Study Day 1 dosing, pre-dose on Study Day 8, 15 and 22, pre-dose on Study Day 29, 24h, 96h post Study Day 29 dosing, pre-dose on Study Day 57, 168h, 840h post Study Day 57 dosingPopulation: The PK concentration population included all enrolled participants treated who had at least 1 quantifiable concentration. Number analyzed refers to number of participants evaluable for specified rows of categories.
Plasma PF-06741086 concentrations were analyzed using a validated, sensitive and specific electrochemiluminescence (ECL) method.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Plasma PF-06741086 Concentrations
24h post Day 1 dosing
|
12180 nanogram/milliliter
Standard Deviation 8500.2
|
15620 nanogram/milliliter
Standard Deviation 8055.3
|
11640 nanogram/milliliter
Standard Deviation 4670.6
|
18130 nanogram/milliliter
Standard Deviation 9111.3
|
15150 nanogram/milliliter
Standard Deviation 9011.0
|
—
|
|
Plasma PF-06741086 Concentrations
96h post Day 29 dosing
|
69130 nanogram/milliliter
Standard Deviation 30459
|
20680 nanogram/milliliter
Standard Deviation 11580
|
74950 nanogram/milliliter
Standard Deviation 27538
|
58150 nanogram/milliliter
Standard Deviation 18753
|
62860 nanogram/milliliter
Standard Deviation 22794
|
—
|
|
Plasma PF-06741086 Concentrations
Pre-dose on Day 57
|
54580 nanogram/milliliter
Standard Deviation 29022
|
18260 nanogram/milliliter
Standard Deviation 15062
|
66480 nanogram/milliliter
Standard Deviation 45529
|
59140 nanogram/milliliter
Standard Deviation 24377
|
56860 nanogram/milliliter
Standard Deviation 25382
|
—
|
|
Plasma PF-06741086 Concentrations
72h post Day 1 dosing
|
17560 nanogram/milliliter
Standard Deviation 10637
|
20850 nanogram/milliliter
Standard Deviation 8433.7
|
24270 nanogram/milliliter
Standard Deviation 8018.9
|
20640 nanogram/milliliter
Standard Deviation 8978.4
|
19100 nanogram/milliliter
Standard Deviation 9591.3
|
—
|
|
Plasma PF-06741086 Concentrations
Pre-dose on Day 8
|
11290 nanogram/milliliter
Standard Deviation 10019
|
14060 nanogram/milliliter
Standard Deviation 6201.2
|
16700 nanogram/milliliter
Standard Deviation 5689.1
|
11940 nanogram/milliliter
Standard Deviation 4981.7
|
11610 nanogram/milliliter
Standard Deviation 7609.2
|
—
|
|
Plasma PF-06741086 Concentrations
Pre-dose on Day 15
|
22850 nanogram/milliliter
Standard Deviation 15142
|
16680 nanogram/milliliter
Standard Deviation 7668.8
|
28180 nanogram/milliliter
Standard Deviation 10163
|
24870 nanogram/milliliter
Standard Deviation 5726.8
|
23860 nanogram/milliliter
Standard Deviation 11048
|
—
|
|
Plasma PF-06741086 Concentrations
Pre-dose on Day 22
|
33010 nanogram/milliliter
Standard Deviation 19724
|
17900 nanogram/milliliter
Standard Deviation 10509
|
41200 nanogram/milliliter
Standard Deviation 17504
|
36450 nanogram/milliliter
Standard Deviation 10432
|
34600 nanogram/milliliter
Standard Deviation 15590
|
—
|
|
Plasma PF-06741086 Concentrations
Pre-dose on Day 29
|
46180 nanogram/milliliter
Standard Deviation 21357
|
16780 nanogram/milliliter
Standard Deviation 7939.7
|
59950 nanogram/milliliter
Standard Deviation 30625
|
41500 nanogram/milliliter
Standard Deviation 13884
|
43840 nanogram/milliliter
Standard Deviation 17161
|
—
|
|
Plasma PF-06741086 Concentrations
24h post Day 29 dosing
|
66500 nanogram/milliliter
Standard Deviation 27135
|
23530 nanogram/milliliter
Standard Deviation 8548.4
|
73780 nanogram/milliliter
Standard Deviation 22425
|
69920 nanogram/milliliter
Standard Deviation 27902
|
68210 nanogram/milliliter
Standard Deviation 26010
|
—
|
|
Plasma PF-06741086 Concentrations
168h post Day 57 dosing
|
53890 nanogram/milliliter
Standard Deviation 43483
|
24800 nanogram/milliliter
Standard Deviation 2994.4
|
87500 nanogram/milliliter
Standard Deviation 37163
|
66700 nanogram/milliliter
Standard Deviation 28971
|
60300 nanogram/milliliter
Standard Deviation 35481
|
—
|
|
Plasma PF-06741086 Concentrations
840h post Day 57 dosing
|
586.6 nanogram/milliliter
Standard Deviation 1318.4
|
—
|
—
|
90.00 nanogram/milliliter
Standard Deviation 180.00
|
406.0 nanogram/milliliter
Standard Deviation 1056.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, 24 and 96 hours post Day 1 dosingPopulation: The PK parameter analysis population included all enrolled participants treated who had at least 1 quantifiable concentration.
AUClast was calculated by linear/Log trapezoidal method.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-06741086
|
1818000 nanogram*hour/milliliter
Geometric Coefficient of Variation 79
|
2675000 nanogram*hour/milliliter
Geometric Coefficient of Variation 41
|
2806000 nanogram*hour/milliliter
Geometric Coefficient of Variation 37
|
2495000 nanogram*hour/milliliter
Geometric Coefficient of Variation 40
|
2130000 nanogram*hour/milliliter
Geometric Coefficient of Variation 61
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, 24 and 96 hours post Day 1 dosing, pre-dose on Day 29, 24 and 96 hours post Day 29 dosingPopulation: The PK parameter analysis population included all enrolled participants treated who had at least 1 quantifiable concentration. Number analyzed refers to number of participants evaluable for specified rows.
Cmax was observed directly from data.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of PF-06741086
Cmax, Day 1
|
14880 nanogram/milliliter
Geometric Coefficient of Variation 70
|
19480 nanogram/milliliter
Geometric Coefficient of Variation 42
|
23070 nanogram/milliliter
Geometric Coefficient of Variation 37
|
19680 nanogram/milliliter
Geometric Coefficient of Variation 51
|
17110 nanogram/milliliter
Geometric Coefficient of Variation 61
|
—
|
|
Maximum Plasma Concentration (Cmax) of PF-06741086
Cmax, Day 29
|
61850 nanogram/milliliter
Geometric Coefficient of Variation 47
|
24150 nanogram/milliliter
Geometric Coefficient of Variation 44
|
73490 nanogram/milliliter
Geometric Coefficient of Variation 38
|
66070 nanogram/milliliter
Geometric Coefficient of Variation 44
|
63930 nanogram/milliliter
Geometric Coefficient of Variation 43
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, 24 and 96 hours post Day 1 dosing, pre-dose on Day 29, 24 and 96 hours post Day 29 dosingPopulation: The PK parameter analysis population included all enrolled participants treated who had at least 1 quantifiable concentration. Number analyzed refers to number of participants evaluable for specified rows.
Cmin was observed directly from data.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06741086
Cmin, Day 29
|
42120 nanogram/milliliter
Geometric Coefficient of Variation 52
|
15000 nanogram/milliliter
Geometric Coefficient of Variation 59
|
53630 nanogram/milliliter
Geometric Coefficient of Variation 61
|
39490 nanogram/milliliter
Geometric Coefficient of Variation 37
|
40790 nanogram/milliliter
Geometric Coefficient of Variation 42
|
—
|
|
Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06741086
Cmin, Day 1
|
7980 nanogram/milliliter
Geometric Coefficient of Variation 112
|
13040 nanogram/milliliter
Geometric Coefficient of Variation 43
|
15660 nanogram/milliliter
Geometric Coefficient of Variation 44
|
11140 nanogram/milliliter
Geometric Coefficient of Variation 41
|
9429 nanogram/milliliter
Geometric Coefficient of Variation 78
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1, 24 and 96 hours post Day 1 dosing, pre-dose on Day 29, 24 and 96 hours post Day 29 dosingPopulation: The PK parameter analysis population included all enrolled participants treated who had at least 1 quantifiable concentration. Number analyzed refers to number of participants evaluable for specified rows.
Tmax was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of PF-06741086
Tmax, Day 29
|
23.7 hours
Interval 23.1 to 94.2
|
23.7 hours
Interval 22.0 to 71.7
|
58.5 hours
Interval 23.3 to 97.0
|
22.8 hours
Interval 22.1 to 94.7
|
23.3 hours
Interval 22.1 to 94.7
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of PF-06741086
Tmax, Day 1
|
70.0 hours
Interval 69.1 to 72.8
|
69.7 hours
Interval 68.2 to 71.1
|
71.6 hours
Interval 67.6 to 72.3
|
70.7 hours
Interval 22.8 to 167.0
|
70.1 hours
Interval 22.8 to 167.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 29, 24 and 96 hours post Day 29 dosingPopulation: The PK parameter analysis population included all enrolled participants treated who had at least 1 quantifiable concentration and in whom at least 1 of the PK parameters of interest was calculated.
The dosing interval tau was 1 week. AUCtau was obtained by linear/log trapezoidal method.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve Over the Dosing Interval Tau (AUCtau) of PF-06741086
|
9045000 nanogram*hour/milliliter
Geometric Coefficient of Variation 49
|
3309000 nanogram*hour/milliliter
Geometric Coefficient of Variation 50
|
11090000 nanogram*hour/milliliter
Geometric Coefficient of Variation 43
|
9248000 nanogram*hour/milliliter
Geometric Coefficient of Variation 38
|
9146000 nanogram*hour/milliliter
Geometric Coefficient of Variation 41
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 29, 24 and 96 hours post Day 29 dosingPopulation: The PK parameter analysis population included all enrolled participants treated who had at least 1 quantifiable concentration and in whom at least 1 of the PK parameters of interest was calculated.
CL/F was calculated by dose/AUCtau.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Apparent Clearance After Oral Dose (CL/F) of PF-06741086
|
33.16 milliliter/hour
Geometric Coefficient of Variation 49
|
45.34 milliliter/hour
Geometric Coefficient of Variation 50
|
40.60 milliliter/hour
Geometric Coefficient of Variation 43
|
32.43 milliliter/hour
Geometric Coefficient of Variation 38
|
32.79 milliliter/hour
Geometric Coefficient of Variation 41
|
—
|
SECONDARY outcome
Timeframe: Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113Population: The analysis population included all enrolled participants who received at least 1 dose of study medication and had a baseline measurement and at least 1 post-dose measurement for at least 1 pharmacodynamic endpoint.
Total amount of tissue factor pathway inhibitor (TFPI) (bound and unbound) in plasma. TFPI is a protease inhibitor which acts as an antagonist of the extrinsic coagulation pathway via inhibition of tissue factor activated coagulation factor VII (FVIIa) and activated factor X (FXa). Human plasma samples were analyzed for total TFPI concentrations using a validated, sensitive and specific high-performance liquid chromatography tandem mass spectrometric method (LC-MS/MS). Mixed model repeated measures (MMRM) was used to analyze the change from baseline on TFPI.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Total Tissue Factor Pathway Inhibitor (TFPI)
TFPI, Change at Day 4
|
39.4 nanogram/milliliter
Standard Deviation 46.10
|
43.2 nanogram/milliliter
Standard Deviation 25.76
|
74.0 nanogram/milliliter
Standard Deviation 22.03
|
86.0 nanogram/milliliter
Standard Deviation 29.71
|
62.7 nanogram/milliliter
Standard Deviation 44.41
|
—
|
|
Change From Baseline in Total Tissue Factor Pathway Inhibitor (TFPI)
TFPI, Change at Day 2
|
3.9 nanogram/milliliter
Standard Deviation 31.43
|
-13.4 nanogram/milliliter
Standard Deviation 17.17
|
8.2 nanogram/milliliter
Standard Deviation 19.83
|
0.4 nanogram/milliliter
Standard Deviation 46.81
|
2.1 nanogram/milliliter
Standard Deviation 38.35
|
—
|
|
Change From Baseline in Total Tissue Factor Pathway Inhibitor (TFPI)
TFPI, Change at Day 8
|
42.7 nanogram/milliliter
Standard Deviation 82.52
|
72.4 nanogram/milliliter
Standard Deviation 10.81
|
120.5 nanogram/milliliter
Standard Deviation 34.41
|
55.9 nanogram/milliliter
Standard Deviation 69.84
|
49.3 nanogram/milliliter
Standard Deviation 73.76
|
—
|
|
Change From Baseline in Total Tissue Factor Pathway Inhibitor (TFPI)
TFPI, Change at Day 15
|
143.9 nanogram/milliliter
Standard Deviation 107.56
|
78.8 nanogram/milliliter
Standard Deviation 43.36
|
186.5 nanogram/milliliter
Standard Deviation 52.80
|
156.1 nanogram/milliliter
Standard Deviation 83.87
|
150.0 nanogram/milliliter
Standard Deviation 92.88
|
—
|
|
Change From Baseline in Total Tissue Factor Pathway Inhibitor (TFPI)
TFPI, Change at Day 22
|
256.1 nanogram/milliliter
Standard Deviation 137.09
|
110.0 nanogram/milliliter
Standard Deviation 80.96
|
301.5 nanogram/milliliter
Standard Deviation 84.39
|
223.3 nanogram/milliliter
Standard Deviation 128.08
|
239.7 nanogram/milliliter
Standard Deviation 128.59
|
—
|
|
Change From Baseline in Total Tissue Factor Pathway Inhibitor (TFPI)
TFPI, Change at Day 29
|
324.2 nanogram/milliliter
Standard Deviation 127.46
|
106.6 nanogram/milliliter
Standard Deviation 77.56
|
334.7 nanogram/milliliter
Standard Deviation 120.67
|
222.1 nanogram/milliliter
Standard Deviation 135.29
|
269.2 nanogram/milliliter
Standard Deviation 136.83
|
—
|
|
Change From Baseline in Total Tissue Factor Pathway Inhibitor (TFPI)
TFPI, Change at Day 30
|
363.8 nanogram/milliliter
Standard Deviation 156.87
|
115.6 nanogram/milliliter
Standard Deviation 86.41
|
347.8 nanogram/milliliter
Standard Deviation 170.70
|
286.7 nanogram/milliliter
Standard Deviation 103.72
|
325.3 nanogram/milliliter
Standard Deviation 133.04
|
—
|
|
Change From Baseline in Total Tissue Factor Pathway Inhibitor (TFPI)
TFPI, Change at Day 33
|
337.7 nanogram/milliliter
Standard Deviation 129.05
|
165.8 nanogram/milliliter
Standard Deviation 35.20
|
351.0 nanogram/milliliter
Standard Deviation 161.54
|
296.3 nanogram/milliliter
Standard Deviation 112.30
|
317.0 nanogram/milliliter
Standard Deviation 117.34
|
—
|
|
Change From Baseline in Total Tissue Factor Pathway Inhibitor (TFPI)
TFPI, Change at Day 57
|
383.3 nanogram/milliliter
Standard Deviation 137.17
|
140.0 nanogram/milliliter
Standard Deviation 126.96
|
460.5 nanogram/milliliter
Standard Deviation 247.37
|
371.0 nanogram/milliliter
Standard Deviation 178.73
|
377.2 nanogram/milliliter
Standard Deviation 152.03
|
—
|
|
Change From Baseline in Total Tissue Factor Pathway Inhibitor (TFPI)
TFPI, Change at Day 85
|
396.7 nanogram/milliliter
Standard Deviation 216.54
|
246.7 nanogram/milliliter
Standard Deviation 51.81
|
492.2 nanogram/milliliter
Standard Deviation 308.46
|
425.0 nanogram/milliliter
Standard Deviation 266.57
|
409.8 nanogram/milliliter
Standard Deviation 230.80
|
—
|
|
Change From Baseline in Total Tissue Factor Pathway Inhibitor (TFPI)
TFPI, Change at Day 113
|
30.0 nanogram/milliliter
Standard Deviation 72.30
|
41.5 nanogram/milliliter
Standard Deviation 28.99
|
39.0 nanogram/milliliter
Standard Deviation 16.15
|
-14.0 nanogram/milliliter
Standard Deviation 33.17
|
9.7 nanogram/milliliter
Standard Deviation 59.94
|
—
|
SECONDARY outcome
Timeframe: Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113Population: The analysis population included all enrolled participants who received at least 1 dose of study medication and had a baseline measurement and at least 1 post-dose measurement for at least 1 pharmacodynamic endpoint.
An ex vivo pharmacodynamic measure of thrombin generation (initiation of thrombin generation), the lag time is the time needed to form the first traces of thrombin.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Thrombin Generation (TGA) Lag Time
TGA lag time, Change at Day 2
|
-7.16 minutes
Standard Deviation 5.865
|
-2.77 minutes
Standard Deviation 1.517
|
-3.93 minutes
Standard Deviation 1.919
|
-4.13 minutes
Standard Deviation 1.238
|
-5.64 minutes
Standard Deviation 4.365
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Lag Time
TGA lag time, Change at Day 4
|
-6.80 minutes
Standard Deviation 6.079
|
-2.80 minutes
Standard Deviation 1.399
|
-3.48 minutes
Standard Deviation 1.957
|
-4.17 minutes
Standard Deviation 1.501
|
-5.49 minutes
Standard Deviation 4.467
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Lag Time
TGA lag time, Change at Day 57
|
-4.73 minutes
Standard Deviation 4.711
|
-2.28 minutes
Standard Deviation 2.020
|
-3.42 minutes
Standard Deviation 1.962
|
-3.78 minutes
Standard Deviation 1.376
|
-4.26 minutes
Standard Deviation 3.346
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Lag Time
TGA lag time,Change at Day 85
|
-6.34 minutes
Standard Deviation 5.745
|
-3.10 minutes
Standard Deviation 1.344
|
-3.27 minutes
Standard Deviation 2.014
|
-3.33 minutes
Standard Deviation 1.755
|
-4.95 minutes
Standard Deviation 4.497
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Lag Time
TGA lag time, Change at Day 113
|
-0.79 minutes
Standard Deviation 7.428
|
0.80 minutes
Standard Deviation 0.283
|
1.53 minutes
Standard Deviation 5.306
|
0.78 minutes
Standard Deviation 5.251
|
-0.06 minutes
Standard Deviation 6.304
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Lag Time
TGA lag time, Change at Day 8
|
-6.94 minutes
Standard Deviation 5.882
|
-2.88 minutes
Standard Deviation 1.292
|
-3.57 minutes
Standard Deviation 2.018
|
-4.43 minutes
Standard Deviation 1.506
|
-5.69 minutes
Standard Deviation 4.327
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Lag Time
TGA lag time, Change at Day 15
|
-6.90 minutes
Standard Deviation 5.897
|
-3.07 minutes
Standard Deviation 1.221
|
-3.27 minutes
Standard Deviation 1.870
|
-4.29 minutes
Standard Deviation 1.342
|
-5.59 minutes
Standard Deviation 4.327
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Lag Time
TGA lag time, Change at Day 22
|
-6.94 minutes
Standard Deviation 5.978
|
-2.80 minutes
Standard Deviation 1.585
|
-3.12 minutes
Standard Deviation 2.097
|
-4.34 minutes
Standard Deviation 1.638
|
-5.64 minutes
Standard Deviation 4.422
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Lag Time
TGA lag time, Change at Day 29
|
-5.33 minutes
Standard Deviation 4.871
|
-2.77 minutes
Standard Deviation 1.392
|
-3.43 minutes
Standard Deviation 2.016
|
-4.32 minutes
Standard Deviation 1.781
|
-4.83 minutes
Standard Deviation 3.537
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Lag Time
TGA lag time, Change at Day 30
|
-5.22 minutes
Standard Deviation 4.893
|
-2.77 minutes
Standard Deviation 1.372
|
-3.50 minutes
Standard Deviation 2.082
|
-4.48 minutes
Standard Deviation 1.681
|
-4.88 minutes
Standard Deviation 3.640
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Lag Time
TGA lag time, Change at Day 33
|
-5.08 minutes
Standard Deviation 4.414
|
-2.40 minutes
Standard Deviation 1.568
|
-3.35 minutes
Standard Deviation 2.261
|
-4.52 minutes
Standard Deviation 1.771
|
-4.83 minutes
Standard Deviation 3.329
|
—
|
SECONDARY outcome
Timeframe: Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113Population: The analysis population included all enrolled participants who received at least 1 dose of study medication and had a baseline measurement and at least 1 post-dose measurement for at least 1 pharmacodynamic endpoint.
An ex vivo pharmacodynamic measure of thrombin generation (initiation of thrombin generation). The peak represents the highest thrombin concentration that can be generated. There may be patients who reach the peak faster or slower than others and this may represent hyper- or hypocoagulability, respectively.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Thrombin Generation (TGA) Peak
TGA peak, Change at Day 2
|
72.93 nanomole
Standard Deviation 35.734
|
70.92 nanomole
Standard Deviation 23.721
|
68.18 nanomole
Standard Deviation 15.693
|
63.41 nanomole
Standard Deviation 9.743
|
68.17 nanomole
Standard Deviation 25.642
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Peak
TGA peak, Change at Day 4
|
60.00 nanomole
Standard Deviation 30.196
|
59.28 nanomole
Standard Deviation 30.156
|
50.87 nanomole
Standard Deviation 20.687
|
51.79 nanomole
Standard Deviation 14.929
|
55.89 nanomole
Standard Deviation 23.278
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Peak
TGA peak, Change at Day 15
|
49.01 nanomole
Standard Deviation 23.471
|
52.57 nanomole
Standard Deviation 28.440
|
46.40 nanomole
Standard Deviation 22.985
|
40.90 nanomole
Standard Deviation 7.886
|
44.96 nanomole
Standard Deviation 17.340
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Peak
TGA peak, Change at Day 8
|
49.36 nanomole
Standard Deviation 32.033
|
56.00 nanomole
Standard Deviation 33.636
|
50.30 nanomole
Standard Deviation 14.019
|
54.36 nanomole
Standard Deviation 15.007
|
51.86 nanomole
Standard Deviation 24.171
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Peak
TGA peak, Change at Day 22
|
44.50 nanomole
Standard Deviation 27.260
|
52.07 nanomole
Standard Deviation 33.558
|
38.15 nanomole
Standard Deviation 16.313
|
44.41 nanomole
Standard Deviation 22.567
|
44.46 nanomole
Standard Deviation 24.042
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Peak
TGA peak, Change at Day 29
|
42.95 nanomole
Standard Deviation 24.026
|
49.72 nanomole
Standard Deviation 29.316
|
38.23 nanomole
Standard Deviation 21.808
|
42.48 nanomole
Standard Deviation 23.057
|
42.72 nanomole
Standard Deviation 22.452
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Peak
TGA peak, Change at Day 30
|
35.93 nanomole
Standard Deviation 26.177
|
51.75 nanomole
Standard Deviation 29.276
|
37.72 nanomole
Standard Deviation 24.136
|
48.62 nanomole
Standard Deviation 21.427
|
41.70 nanomole
Standard Deviation 23.878
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Peak
TGA peak, Change at Day 33
|
76.68 nanomole
Standard Deviation 69.887
|
46.83 nanomole
Standard Deviation 37.084
|
36.25 nanomole
Standard Deviation 21.955
|
54.10 nanomole
Standard Deviation 28.276
|
66.42 nanomole
Standard Deviation 53.861
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Peak
TGA peak, Change at Day 57
|
37.13 nanomole
Standard Deviation 21.866
|
32.57 nanomole
Standard Deviation 20.368
|
34.67 nanomole
Standard Deviation 20.584
|
33.93 nanomole
Standard Deviation 7.688
|
35.53 nanomole
Standard Deviation 15.716
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Peak
TGA peak, Change at Day 85
|
37.60 nanomole
Standard Deviation 21.142
|
69.92 nanomole
Standard Deviation 40.250
|
30.15 nanomole
Standard Deviation 18.614
|
30.15 nanomole
Standard Deviation 22.743
|
34.16 nanomole
Standard Deviation 21.306
|
—
|
|
Change From Baseline in Thrombin Generation (TGA) Peak
TGA peak, Change at Day 113
|
24.37 nanomole
Standard Deviation 33.703
|
16.05 nanomole
Standard Deviation 36.557
|
43.33 nanomole
Standard Deviation 68.794
|
6.93 nanomole
Standard Deviation 15.334
|
16.32 nanomole
Standard Deviation 27.345
|
—
|
SECONDARY outcome
Timeframe: Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113Population: The analysis population included all enrolled participants who received at least 1 dose of study medication and had a baseline measurement and at least 1 post-dose measurement for at least 1 pharmacodynamic endpoint.
An ex vivo pharmacodynamic measure of thrombin generation. The endogenous TGA potential represents the total amount of active thrombin formed during thrombin generation and the peak height the maximal amount of thrombin formed.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Endogenous Thrombin Generation (TGA) Potential
Endogenous TGA Potential, Change at Day 22
|
646.9 nanomole*minute
Standard Deviation 295.05
|
589.0 nanomole*minute
Standard Deviation 274.33
|
647.0 nanomole*minute
Standard Deviation 236.38
|
731.4 nanomole*minute
Standard Deviation 302.89
|
689.1 nanomole*minute
Standard Deviation 290.60
|
—
|
|
Change From Baseline in Endogenous Thrombin Generation (TGA) Potential
Endogenous TGA Potential, Change at Day 29
|
588.2 nanomole*minute
Standard Deviation 239.00
|
623.0 nanomole*minute
Standard Deviation 188.84
|
618.3 nanomole*minute
Standard Deviation 276.51
|
660.5 nanomole*minute
Standard Deviation 340.36
|
624.3 nanomole*minute
Standard Deviation 282.93
|
—
|
|
Change From Baseline in Endogenous Thrombin Generation (TGA) Potential
Endogenous TGA Potential, Change at Day 30
|
494.8 nanomole*minute
Standard Deviation 247.86
|
672.0 nanomole*minute
Standard Deviation 226.25
|
603.3 nanomole*minute
Standard Deviation 332.44
|
710.2 nanomole*minute
Standard Deviation 272.54
|
592.7 nanomole*minute
Standard Deviation 270.33
|
—
|
|
Change From Baseline in Endogenous Thrombin Generation (TGA) Potential
Endogenous TGA Potential, Change at Day 57
|
586.8 nanomole*minute
Standard Deviation 200.04
|
445.2 nanomole*minute
Standard Deviation 220.86
|
564.5 nanomole*minute
Standard Deviation 287.43
|
579.7 nanomole*minute
Standard Deviation 147.04
|
583.3 nanomole*minute
Standard Deviation 167.42
|
—
|
|
Change From Baseline in Endogenous Thrombin Generation (TGA) Potential
Endogenous TGA Potential, Change at Day 85
|
566.6 nanomole*minute
Standard Deviation 202.22
|
812.2 nanomole*minute
Standard Deviation 198.80
|
526.7 nanomole*minute
Standard Deviation 297.03
|
493.7 nanomole*minute
Standard Deviation 368.68
|
532.9 nanomole*minute
Standard Deviation 280.20
|
—
|
|
Change From Baseline in Endogenous Thrombin Generation (TGA) Potential
Endogenous TGA Potential, Change at Day 113
|
256.4 nanomole*minute
Standard Deviation 347.91
|
50.5 nanomole*minute
Standard Deviation 290.62
|
306.5 nanomole*minute
Standard Deviation 440.04
|
142.3 nanomole*minute
Standard Deviation 361.25
|
203.8 nanomole*minute
Standard Deviation 344.10
|
—
|
|
Change From Baseline in Endogenous Thrombin Generation (TGA) Potential
Endogenous TGA Potential, Change at Day 2
|
864.0 nanomole*minute
Standard Deviation 250.60
|
816.8 nanomole*minute
Standard Deviation 211.13
|
999.8 nanomole*minute
Standard Deviation 249.59
|
1065.3 nanomole*minute
Standard Deviation 161.71
|
964.6 nanomole*minute
Standard Deviation 227.95
|
—
|
|
Change From Baseline in Endogenous Thrombin Generation (TGA) Potential
Endogenous TGA Potential, Change at Day 4
|
766.7 nanomole*minute
Standard Deviation 236.94
|
714.8 nanomole*minute
Standard Deviation 275.75
|
808.7 nanomole*minute
Standard Deviation 288.78
|
825.1 nanomole*minute
Standard Deviation 294.44
|
795.9 nanomole*minute
Standard Deviation 258.54
|
—
|
|
Change From Baseline in Endogenous Thrombin Generation (TGA) Potential
Endogenous TGA Potential, Change at Day 8
|
691.9 nanomole*minute
Standard Deviation 301.43
|
659.8 nanomole*minute
Standard Deviation 295.11
|
796.5 nanomole*minute
Standard Deviation 151.00
|
918.6 nanomole*minute
Standard Deviation 276.26
|
805.2 nanomole*minute
Standard Deviation 301.66
|
—
|
|
Change From Baseline in Endogenous Thrombin Generation (TGA) Potential
Endogenous TGA Potential, Change at Day 15
|
674.9 nanomole*minute
Standard Deviation 244.61
|
608.5 nanomole*minute
Standard Deviation 242.81
|
800.8 nanomole*minute
Standard Deviation 334.99
|
639.3 nanomole*minute
Standard Deviation 145.74
|
657.1 nanomole*minute
Standard Deviation 194.32
|
—
|
|
Change From Baseline in Endogenous Thrombin Generation (TGA) Potential
Endogenous TGA Potential, Change at Day 33
|
716.5 nanomole*minute
Standard Deviation 391.60
|
606.0 nanomole*minute
Standard Deviation 280.39
|
583.7 nanomole*minute
Standard Deviation 291.25
|
848.8 nanomole*minute
Standard Deviation 387.17
|
776.6 nanomole*minute
Standard Deviation 376.05
|
—
|
SECONDARY outcome
Timeframe: Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113Population: The analysis population included all enrolled participants who received at least 1 dose of study medication and had a baseline measurement and at least 1 post-dose measurement for at least 1 pharmacodynamic endpoint.
An in vivo pharmacodynamic measure of thrombin generation (prothrombin cleavage). Prothrombin fragment 1+2 (F 1+2) is the amino terminus fragment of the prothrombin molecule. It is a polypeptide with a half-life of approximately 90 minutes. F 1+2 is released from prothrombin when prothrombin is converted to thrombin by the prothrombinase complex.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Prothrombin Fragments 1 + 2
Prothrombin fragments 1 + 2, Change at Day 30
|
655.7 picomole/liter
Standard Deviation 496.35
|
486.0 picomole/liter
Standard Deviation 608.26
|
521.0 picomole/liter
Standard Deviation 165.25
|
580.8 picomole/liter
Standard Deviation 507.83
|
618.3 picomole/liter
Standard Deviation 480.35
|
—
|
|
Change From Baseline in Prothrombin Fragments 1 + 2
Prothrombin fragments 1 + 2, Change at Day 8
|
450.3 picomole/liter
Standard Deviation 396.09
|
562.2 picomole/liter
Standard Deviation 605.07
|
413.0 picomole/liter
Standard Deviation 171.50
|
580.7 picomole/liter
Standard Deviation 259.63
|
515.5 picomole/liter
Standard Deviation 328.78
|
—
|
|
Change From Baseline in Prothrombin Fragments 1 + 2
Prothrombin fragments 1 + 2, Change at Day 15
|
481.7 picomole/liter
Standard Deviation 330.26
|
349.7 picomole/liter
Standard Deviation 212.59
|
389.2 picomole/liter
Standard Deviation 228.56
|
571.1 picomole/liter
Standard Deviation 474.23
|
526.4 picomole/liter
Standard Deviation 395.34
|
—
|
|
Change From Baseline in Prothrombin Fragments 1 + 2
Prothrombin fragments 1 + 2, Change at Day 22
|
608.1 picomole/liter
Standard Deviation 336.97
|
322.3 picomole/liter
Standard Deviation 161.76
|
420.2 picomole/liter
Standard Deviation 166.66
|
524.1 picomole/liter
Standard Deviation 577.08
|
566.1 picomole/liter
Standard Deviation 456.08
|
—
|
|
Change From Baseline in Prothrombin Fragments 1 + 2
Prothrombin fragments 1 + 2, Change at Day 29
|
650.3 picomole/liter
Standard Deviation 415.58
|
288.0 picomole/liter
Standard Deviation 259.19
|
577.7 picomole/liter
Standard Deviation 302.76
|
429.3 picomole/liter
Standard Deviation 257.91
|
531.3 picomole/liter
Standard Deviation 344.06
|
—
|
|
Change From Baseline in Prothrombin Fragments 1 + 2
Prothrombin fragments 1 + 2, Change at Day 33
|
761.3 picomole/liter
Standard Deviation 509.02
|
642.5 picomole/liter
Standard Deviation 759.02
|
1527.7 picomole/liter
Standard Deviation 2499.96
|
609.2 picomole/liter
Standard Deviation 380.74
|
685.3 picomole/liter
Standard Deviation 435.87
|
—
|
|
Change From Baseline in Prothrombin Fragments 1 + 2
Prothrombin fragments 1 + 2, Change at Day 57
|
586.5 picomole/liter
Standard Deviation 473.53
|
216.5 picomole/liter
Standard Deviation 173.44
|
465.3 picomole/liter
Standard Deviation 300.84
|
463.5 picomole/liter
Standard Deviation 397.57
|
525.0 picomole/liter
Standard Deviation 421.78
|
—
|
|
Change From Baseline in Prothrombin Fragments 1 + 2
Prothrombin fragments 1 + 2, Change at Day 85
|
588.3 picomole/liter
Standard Deviation 483.80
|
378.2 picomole/liter
Standard Deviation 207.16
|
470.2 picomole/liter
Standard Deviation 244.21
|
362.2 picomole/liter
Standard Deviation 378.54
|
483.9 picomole/liter
Standard Deviation 436.47
|
—
|
|
Change From Baseline in Prothrombin Fragments 1 + 2
Prothrombin fragments 1 + 2, Change at Day 113
|
-6.6 picomole/liter
Standard Deviation 151.87
|
16.5 picomole/liter
Standard Deviation 19.09
|
-75.5 picomole/liter
Standard Deviation 76.86
|
-58.2 picomole/liter
Standard Deviation 121.15
|
-30.4 picomole/liter
Standard Deviation 135.52
|
—
|
|
Change From Baseline in Prothrombin Fragments 1 + 2
Prothrombin fragments 1 + 2, Change at Day 2
|
430.0 picomole/liter
Standard Deviation 383.03
|
498.3 picomole/liter
Standard Deviation 484.40
|
275.7 picomole/liter
Standard Deviation 206.71
|
438.9 picomole/liter
Standard Deviation 507.68
|
434.4 picomole/liter
Standard Deviation 432.08
|
—
|
|
Change From Baseline in Prothrombin Fragments 1 + 2
Prothrombin fragments 1 + 2, Change at Day 4
|
548.1 picomole/liter
Standard Deviation 455.67
|
1096.7 picomole/liter
Standard Deviation 1403.57
|
574.5 picomole/liter
Standard Deviation 363.37
|
730.3 picomole/liter
Standard Deviation 537.21
|
639.2 picomole/liter
Standard Deviation 487.82
|
—
|
SECONDARY outcome
Timeframe: Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113Population: The analysis population included all enrolled participants who received at least 1 dose of study medication and had a baseline measurement and at least 1 post-dose measurement for at least 1 pharmacodynamic endpoint.
An in vivo pharmacodynamic measure of thrombin generation (fibrin degradation). D-dimer is a fibrin degradation product, a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. D-dimer is one of the protein fragments produced when a blood clot gets dissolved in the body. It is normally undetectable or detectable at a very low level unless the body is forming and breaking down blood clots. Then, its level in the blood can significantly rise.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in D-Dimer
D-dimer, Change at Day 15
|
0.0979 microgram/milliliter
Standard Deviation 0.25666
|
0.1942 microgram/milliliter
Standard Deviation 0.28748
|
0.2500 microgram/milliliter
Standard Deviation 0.23424
|
0.1900 microgram/milliliter
Standard Deviation 0.82310
|
0.1439 microgram/milliliter
Standard Deviation 0.58769
|
—
|
|
Change From Baseline in D-Dimer
D-dimer, Change at Day 85
|
0.1664 microgram/milliliter
Standard Deviation 0.30521
|
0.5860 microgram/milliliter
Standard Deviation 1.00003
|
0.1833 microgram/milliliter
Standard Deviation 0.43840
|
0.2300 microgram/milliliter
Standard Deviation 0.60395
|
0.1958 microgram/milliliter
Standard Deviation 0.44682
|
—
|
|
Change From Baseline in D-Dimer
D-dimer, Change at Day 22
|
0.1364 microgram/milliliter
Standard Deviation 0.27802
|
0.2167 microgram/milliliter
Standard Deviation 0.33877
|
0.2000 microgram/milliliter
Standard Deviation 0.26109
|
0.1829 microgram/milliliter
Standard Deviation 1.27802
|
0.1596 microgram/milliliter
Standard Deviation 0.88887
|
—
|
|
Change From Baseline in D-Dimer
D-dimer, Change at Day 29
|
0.0633 microgram/milliliter
Standard Deviation 0.20029
|
0.2308 microgram/milliliter
Standard Deviation 0.32355
|
0.1517 microgram/milliliter
Standard Deviation 0.42347
|
-0.0129 microgram/milliliter
Standard Deviation 1.17491
|
0.0223 microgram/milliliter
Standard Deviation 0.84172
|
—
|
|
Change From Baseline in D-Dimer
D-dimer, Change at Day 2
|
0.0393 microgram/milliliter
Standard Deviation 0.16303
|
0.0792 microgram/milliliter
Standard Deviation 0.22238
|
0.1900 microgram/milliliter
Standard Deviation 0.09301
|
0.1086 microgram/milliliter
Standard Deviation 0.30536
|
0.0739 microgram/milliliter
Standard Deviation 0.23790
|
—
|
|
Change From Baseline in D-Dimer
D-dimer, Change at Day 4
|
0.2050 microgram/milliliter
Standard Deviation 0.24491
|
0.2842 microgram/milliliter
Standard Deviation 0.36896
|
0.3217 microgram/milliliter
Standard Deviation 0.23248
|
0.6729 microgram/milliliter
Standard Deviation 0.62524
|
0.4389 microgram/milliliter
Standard Deviation 0.51676
|
—
|
|
Change From Baseline in D-Dimer
D-dimer, Change at Day 8
|
0.0743 microgram/milliliter
Standard Deviation 0.26111
|
0.2017 microgram/milliliter
Standard Deviation 0.29753
|
0.3292 microgram/milliliter
Standard Deviation 0.40635
|
0.5614 microgram/milliliter
Standard Deviation 0.54901
|
0.3179 microgram/milliliter
Standard Deviation 0.48422
|
—
|
|
Change From Baseline in D-Dimer
D-dimer, Change at Day 113
|
-0.1000 microgram/milliliter
Standard Deviation 0.22127
|
0.1875 microgram/milliliter
Standard Deviation 0.26517
|
0.0175 microgram/milliliter
Standard Deviation 0.41838
|
-0.7833 microgram/milliliter
Standard Deviation 1.60090
|
-0.4154 microgram/milliliter
Standard Deviation 1.10366
|
—
|
|
Change From Baseline in D-Dimer
D-dimer, Change at Day 30
|
0.1350 microgram/milliliter
Standard Deviation 0.32388
|
0.1492 microgram/milliliter
Standard Deviation 0.26345
|
0.2133 microgram/milliliter
Standard Deviation 0.33914
|
-0.0833 microgram/milliliter
Standard Deviation 1.31549
|
0.0258 microgram/milliliter
Standard Deviation 0.92048
|
—
|
|
Change From Baseline in D-Dimer
D-dimer, Change at Day 33
|
0.0800 microgram/milliliter
Standard Deviation 0.28796
|
0.1283 microgram/milliliter
Standard Deviation 0.37519
|
0.1233 microgram/milliliter
Standard Deviation 0.49855
|
-0.1700 microgram/milliliter
Standard Deviation 1.68635
|
-0.0450 microgram/milliliter
Standard Deviation 1.16076
|
—
|
|
Change From Baseline in D-Dimer
D-dimer, Change at Day 57
|
0.1942 microgram/milliliter
Standard Deviation 0.30049
|
0.2175 microgram/milliliter
Standard Deviation 0.22554
|
0.1233 microgram/milliliter
Standard Deviation 0.36122
|
0.4033 microgram/milliliter
Standard Deviation 0.37120
|
0.2988 microgram/milliliter
Standard Deviation 0.34001
|
—
|
SECONDARY outcome
Timeframe: Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113Population: The analysis population included all enrolled participants who received at least 1 dose of study medication and had a baseline measurement and at least 1 post-dose measurement for at least 1 pharmacodynamic endpoint.
An ex vivo pharmacodynamic measure of thrombin generation (via extrinsic pathway). Clotting time is measured using a dilute prothrombin time reagent consisting of a unique formulation of relipidated recombinant tissue factor and calcium.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Dilute Prothrombin Time
Dilute prothrombin Time, Change at Day 113
|
-16.44 seconds
Standard Deviation 13.578
|
14.30 seconds
Standard Deviation 61.235
|
-39.63 seconds
Standard Deviation 20.182
|
-12.78 seconds
Standard Deviation 28.226
|
-14.75 seconds
Standard Deviation 20.682
|
—
|
|
Change From Baseline in Dilute Prothrombin Time
Dilute prothrombin Time, Change at Day 2
|
-27.84 seconds
Standard Deviation 21.023
|
-13.32 seconds
Standard Deviation 25.780
|
-31.25 seconds
Standard Deviation 13.606
|
-17.14 seconds
Standard Deviation 26.167
|
-22.49 seconds
Standard Deviation 23.470
|
—
|
|
Change From Baseline in Dilute Prothrombin Time
Dilute prothrombin Time, Change at Day 4
|
-30.03 seconds
Standard Deviation 24.312
|
-17.87 seconds
Standard Deviation 20.042
|
-34.50 seconds
Standard Deviation 18.306
|
-14.70 seconds
Standard Deviation 30.971
|
-22.36 seconds
Standard Deviation 27.907
|
—
|
|
Change From Baseline in Dilute Prothrombin Time
Dilute prothrombin Time, Change at Day 8
|
-23.63 seconds
Standard Deviation 19.991
|
-15.10 seconds
Standard Deviation 22.129
|
-31.23 seconds
Standard Deviation 19.645
|
-20.97 seconds
Standard Deviation 33.969
|
-22.30 seconds
Standard Deviation 26.813
|
—
|
|
Change From Baseline in Dilute Prothrombin Time
Dilute prothrombin Time, Change at Day 15
|
-20.73 seconds
Standard Deviation 23.070
|
-19.33 seconds
Standard Deviation 20.853
|
-33.53 seconds
Standard Deviation 14.880
|
1.11 seconds
Standard Deviation 27.208
|
-9.81 seconds
Standard Deviation 26.753
|
—
|
|
Change From Baseline in Dilute Prothrombin Time
Dilute prothrombin Time, Change at Day 22
|
-21.40 seconds
Standard Deviation 22.351
|
-10.55 seconds
Standard Deviation 16.057
|
-26.78 seconds
Standard Deviation 32.501
|
-21.61 seconds
Standard Deviation 30.842
|
-21.51 seconds
Standard Deviation 25.877
|
—
|
|
Change From Baseline in Dilute Prothrombin Time
Dilute prothrombin Time, Change at Day 29
|
-15.32 seconds
Standard Deviation 13.867
|
-7.10 seconds
Standard Deviation 20.643
|
-40.40 seconds
Standard Deviation 22.458
|
-18.03 seconds
Standard Deviation 24.600
|
-16.78 seconds
Standard Deviation 19.613
|
—
|
|
Change From Baseline in Dilute Prothrombin Time
Dilute prothrombin Time, Change at Day 30
|
-13.27 seconds
Standard Deviation 13.399
|
-23.45 seconds
Standard Deviation 19.413
|
-45.18 seconds
Standard Deviation 21.372
|
-17.47 seconds
Standard Deviation 25.729
|
-15.37 seconds
Standard Deviation 19.680
|
—
|
|
Change From Baseline in Dilute Prothrombin Time
Dilute prothrombin Time, Change at Day 33
|
-23.35 seconds
Standard Deviation 17.690
|
-21.23 seconds
Standard Deviation 20.010
|
-29.10 seconds
Standard Deviation 20.783
|
-19.97 seconds
Standard Deviation 19.297
|
-21.66 seconds
Standard Deviation 17.737
|
—
|
|
Change From Baseline in Dilute Prothrombin Time
Dilute prothrombin Time, Change at Day 57
|
-14.75 seconds
Standard Deviation 14.393
|
-12.03 seconds
Standard Deviation 30.806
|
-26.80 seconds
Standard Deviation 12.911
|
-11.72 seconds
Standard Deviation 42.872
|
-13.23 seconds
Standard Deviation 30.531
|
—
|
|
Change From Baseline in Dilute Prothrombin Time
Dilute prothrombin TIme, Change at Day 85
|
-20.99 seconds
Standard Deviation 25.424
|
-25.80 seconds
Standard Deviation 24.334
|
-23.43 seconds
Standard Deviation 26.166
|
-12.42 seconds
Standard Deviation 34.871
|
-17.03 seconds
Standard Deviation 29.148
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Study Day 113Population: This analysis population included all participants who received at least 1 dose of investigational drug.
Human plasma ADA samples were analyzed for the detection of anti PF-06741086 antibodies by using semi-quantitative electrochemiluminescence (ECL) method. The criterion for positive result of ADA samples was ADA titer \>=1.53. Treatment induced are negative prior to dosing and become positive during/after dosing. Treatment boosted are positive prior to dosing but titer increases during/after dosing.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 Participants
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 Participants
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Tested Positive for Anti-PF-06741086 Antibody (ADA)
Participants with treatment induced ADA incidence
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Who Tested Positive for Anti-PF-06741086 Antibody (ADA)
ADA incidence
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Who Tested Positive for Anti-PF-06741086 Antibody (ADA)
Participants with treatment boosted ADA incidence
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Study Day 113Population: Only positive ADA samples and the corresponding baseline sample were tested in the NAb assay.
Human plasma NAb samples were analyzed for the presence or absence of NAb to PF-06741086 using semi-quantitative electrochemiluminescence (ECL) method. Treatment induced are negative prior to dosing and become positive during/after dosing. Treatment boosted are positive prior to dosing but titer increases during/after dosing.
Outcome measures
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=1 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=2 Participants
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=3 Participants
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Tested Positive for Neutralizing Antibody (NAb)
Participants with treatment induced NAb incidence
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Tested Positive for Neutralizing Antibody (NAb)
Participants with treatment boosted NAb incidence
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Tested Positive for Neutralizing Antibody (NAb)
NAb incidence
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
PF-06741086 300 mg SC QW Non-Inhibitor
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-06741086 450 mg SC QW Non-Inhibitor
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-06741086 300 mg SC QW Inhibitor
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Overall PF-06741086 300 mg SC
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Total
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 participants at risk
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 participants at risk
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 participants at risk
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 participants at risk
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 participants at risk
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 participants at risk
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Tooth socket haemorrhage
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Appendicitis
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Social circumstances
Physical assault
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Other adverse events
| Measure |
PF-06741086 300 mg SC QW Non-Inhibitor
n=7 participants at risk
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC Loading + 150 mg SC QW Non-Inhibitor
n=6 participants at risk
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg loading dose on Day 1 and 150 mg subcutaneously (SC) once weekly (QW) from Day 8 to Day 78.
|
PF-06741086 450 mg SC QW Non-Inhibitor
n=6 participants at risk
Participants without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 450 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
PF-06741086 300 mg SC QW Inhibitor
n=7 participants at risk
Participants with inhibitors to Factor VIII (FVIII) or Factor IX (FIX) in this cohort received PF-06741086 300 mg subcutaneously (SC) once weekly (QW) from Day 1 to Day 78.
|
Overall PF-06741086 300 mg SC
n=14 participants at risk
The overall PF-06741086 300 mg SC group combined participants from both the PF-06741086 300 mg SC QW non-inhibitor and inhibitor dose cohorts.
|
Total
n=26 participants at risk
The total group combined participants from all PF-06741086 cohorts in this study.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.7%
2/26 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Injection site bruising
|
28.6%
2/7 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
2/14 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.7%
2/26 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Injection site erythema
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Injection site induration
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.7%
2/26 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Injection site pain
|
14.3%
1/7 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.5%
3/26 • Number of events 9 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Injection site pruritus
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Injection site swelling
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
2/6 • Number of events 3 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.5%
3/26 • Number of events 4 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Injection site warmth
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.7%
2/26 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.7%
2/26 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.7%
2/26 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Occupational exposure to product
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Fibrin D dimer increased
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.7%
2/26 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Troponin I increased
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
2/14 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.7%
2/26 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Troponin increased
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
2/14 • Number of events 3 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.7%
2/26 • Number of events 3 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Haemophilic arthropathy
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
2/6 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.7%
2/26 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
3.8%
1/26 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
33.3%
2/6 • Number of events 2 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • Number of events 1 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
11.5%
3/26 • Number of events 3 • 113 days
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60