| Primary | Number of Adverse Events (AEs) | Adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. | Posted | | Number | | events | | Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product. | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG003 | Vatreptacog Alfa 40 mcg/kg | Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG004 | Vatreptacog Alfa 80 mcg/kg | Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG005 | rFVIIa 90 mcg/kg | Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts. |
| | Units | Counts |
|---|
| Participants | - OG00016
- OG00119
- OG00216
- OG003
|
| | Title | Denominators | Categories |
|---|
| All AEs | | |
| |
| Secondary | Activated Recombinant Human Factor VII Analogue Activity in the Blood | | All randomised patients in top three dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violation of the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. | Posted | | Mean | Standard Deviation | IU/mL | | 0-24 hours after trial product administration | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. |
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| Secondary | Prothrombin Time (PT) | The test measures the clotting time of plasma following the activation of tissue factor (TF also called thromboplastin) and calcium to hypocalcemic plasma. PT was provided in percent based on the measured PT in seconds and related/converted with the relevant standard curve. The percent value was derived based on the hyperbolic relation between PT (sec) and % PT activity. | Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. | Posted | | Mean | Standard Deviation | percentage (%) | | pre-dose - 12 hours after trial product administration | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | |
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| Secondary | F1 + 2 (Prothrombin Fragments 1+2) | Thrombin and F1+2 are formed in equimolar quantities by the enzymatic cleavage of prothrombin (FII), and F1+2 thus indicate that thrombin has been generated. | Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. | Posted | | Mean | Standard Deviation | pmol/L | | pre-dose - 12 hours after trial product administration | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. |
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| Secondary | Activated Partial Thromboplastin Time (aPTT) | The aPTT time measured in clinical samples reflects both the effect of the drugs (generation of thrombin and FXa) and the presence of rFVIIa /rFVIIa analogue in the plasma samples causing a dose dependent shortening of the clotting time. | Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. | Posted | | Mean | Standard Deviation | Sec | | pre-dose - 12 hours after trial product administration | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. |
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| Secondary | Cessation of Bleeding: Number of Doses Needed to Control Bleeding | | All randomised patients for whom at least one of the efficacy variables is assessed were to be included in the full analysis set (FAS). For the outcome measure 1 subject did not contribute to the data. | Posted | | Number | | bleeding episodes | | Within 9 hours after first trial product administration or need of additional haemostatic medication within 9 hours after first trial administration additional haemostatic agents required to control bleed (treatment failure) | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. |
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| Secondary | Number of Subjects With Need for Additional Haemostatic Agents | | All randomised patients for whom at least one of the efficacy variables is assessed were to be included in the full analysis set (FAS). For the outcome measure 9 subjects did not contribute to the data. | Posted | | Number | | participants | | within 24 hours after successful control of bleeding episode with trial product | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. |
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| Secondary | Pharmacokinetic Parameters Based on FVIIa Activity: AUC 0-t (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to the Time (t) ) | | All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (IU*h)/mL | | 0-24 hours after trial product administration | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. |
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| Secondary | Pharmacokinetic Parameters Based on FVIIa Activity: AUC(0-inf) (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to Infinity) | | All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | (IU*h)/mL | | 0-24 hours after trial product administration | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. |
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| Secondary | Pharmacokinetic Parameters Based on FVIIa Activity: MRT (Mean Residence Time) | | All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis. | Posted | | Mean | Standard Deviation | hours | | 0-24 hours after trial product administration | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. |
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| Secondary | Pharmacokinetic Parameters Based on FVIIa Activity: t½ (Terminal Half-life) | | All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis. | Posted | | Mean | Standard Deviation | hours | | 0-24 hours after trial product administration | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. |
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| Secondary | Pharmacokinetic Parameters Based on FVIIa Activity: CL (Total Clearance) | | All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis. | Posted | | Median | Full Range | mL/h | | 0-24 hours after trial product administration | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. |
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| Secondary | Pharmakokinetic Parameters Based on FVIIa Activity: Vss (Distribution Volume at Steady State) | | All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis. | Posted | | Median | Full Range | mL/kg | | 0-24 hours after trial product administration | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. |
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| Secondary | Immunogenicity (Inhibitor Development) | Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or rFVIIa. | Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. | Posted | | Number | | participants | | Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product. | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. |
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| Secondary | Biochemistry: ALAT (Alanine Aminotransferase) | | Safety analysis set includes all subjects who received at least one dose of the investigational product. | Posted | | Mean | Standard Deviation | U/L | | screening visit, pre-dose and 12 hours after dosing | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG003 | Vatreptacog Alfa 40 mcg/kg |
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| Secondary | Biochemistry: Creatinine | | Safety analysis set includes all subjects who received at least one dose of the investigational product. | Posted | | Mean | Standard Deviation | micromol/L | | screening visit, pre-dose and 12 hours after dosing | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG003 | Vatreptacog Alfa 40 mcg/kg |
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| Secondary | Haematology: Haemoglobin | | Safety analysis set includes all subjects who received at least one dose of the investigational product. | Posted | | Mean | Standard Deviation | g/dL | | screening visit, pre-dose and 12 hours after dosing | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG003 | Vatreptacog Alfa 40 mcg/kg |
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| Secondary | Haematology: Red Cell Count | | Safety analysis set includes all subjects who received at least one dose of the investigational product. | Posted | | Mean | Standard Deviation | 10^12 cells/L | | screening visit, pre-dose and 12 hours after dosing | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG003 | Vatreptacog Alfa 40 mcg/kg |
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| Secondary | Haematology: Packed Cell Volume | | Safety analysis set includes all subjects who received at least one dose of the investigational product. | Posted | | Mean | Standard Deviation | percentage (%) | | screening visit, pre-dose and 12 hours after dosing | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG003 | Vatreptacog Alfa 40 mcg/kg |
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| Secondary | Haematology: White Cell Count | | Safety analysis set includes all subjects who received at least one dose of the investigational product. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | screening visit, pre-dose and 12 hours after dosing | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG003 | Vatreptacog Alfa 40 mcg/kg |
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| Secondary | Haematology: Platelet Count | | Safety analysis set includes all subjects who received at least one dose of the investigational product. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | screening visit, pre-dose and 12 hours after dosing | | | | ID | Title | Description |
|---|
| OG000 | Vatreptacog Alfa 5 mcg/kg | Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG001 | Vatreptacog Alfa 10 mcg/kg | Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG002 | Vatreptacog Alfa 20 mcg/kg | Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm. | | OG003 | Vatreptacog Alfa 40 mcg/kg |
|