Trial Outcomes & Findings for Early Prophylaxis Immunologic Challenge (EPIC) Study (NCT NCT01376700)
NCT ID: NCT01376700
Last Updated: 2021-05-24
Results Overview
Inhibitor testing will be performed in the central laboratory and a non-zero result must be confirmed in the central laboratory as soon as possible, preferably 1 week after inhibitor testing. Confirmed FVIII inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 Bethesda Units (BU)/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either: - i. High FVIII inhibitor titer (\> 5 BU/mL) or - ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
22 participants
Primary outcome timeframe
50 exposure days to ADVATE
Results posted on
2021-05-24
Participant Flow
Enrollment was conducted in Europe and North America at 19 clinical sites.
22 participants were enrolled. One was a screen failure; one did not have screening laboratory assessments performed prior to study termination; and one met screening criteria, but was not exposed to investigational product prior to study termination. Therefore 19 participants were treated
Participant milestones
| Measure |
ADVATE - Prophylactic Regimen
Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
ADVATE - Prophylactic Regimen
Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
|
|---|---|
|
Overall Study
Sponsor terminated study early
|
8
|
|
Overall Study
Low or high titer inhibitor
|
8
|
Baseline Characteristics
Early Prophylaxis Immunologic Challenge (EPIC) Study
Baseline characteristics by cohort
| Measure |
ADVATE - Prophylactic Regimen
n=19 Participants
Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
|
|---|---|
|
Age, Continuous
|
43.3 weeks
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 50 exposure days to ADVATEPopulation: Safety Analysis Set All study participants had severe Hemophilia A, less than 1% Factor VIII levels. (ie there were no moderately severe hemophilia A participants (FVIII levels \>1% to ≤ 2%) in this study.
Inhibitor testing will be performed in the central laboratory and a non-zero result must be confirmed in the central laboratory as soon as possible, preferably 1 week after inhibitor testing. Confirmed FVIII inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 Bethesda Units (BU)/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either: - i. High FVIII inhibitor titer (\> 5 BU/mL) or - ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL).
Outcome measures
| Measure |
ADVATE - Prophylactic Regimen
n=19 Participants
Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter. Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.
|
MTPs
≤4 previous FVIII exposures
|
|---|---|---|
|
Number of Participants With Severe and Moderately Severe Hemophilia A (FVIII ≤ 2%) With Factor VIII (FVIII) Inhibitor Formation Within the First 50 Exposure Days to ADVATE
|
8 participants
|
—
|
SECONDARY outcome
Timeframe: 50 exposure days to ADVATEPopulation: Safety Analysis Set
Inhibitor testing will be performed in the central laboratory and a non-zero result must be confirmed in the central laboratory as soon as possible, preferably 1 week after inhibitor testing. Confirmed FVIII inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 Bethesda Units (BU)/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either: - i. High FVIII inhibitor titer (\> 5 BU/mL) or - ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL).
Outcome measures
| Measure |
ADVATE - Prophylactic Regimen
n=19 Participants
Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter. Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.
|
MTPs
≤4 previous FVIII exposures
|
|---|---|---|
|
Number of Participants With Severe Hemophilia A (FVIII ≤ 1%) With Factor VIII (FVIII) Inhibitor Formation Within the First 50 Exposure Days to ADVATE
|
8 participants
|
—
|
SECONDARY outcome
Timeframe: 50 exposure days to ADVATEPopulation: Safety Analysis Set
Confirmed inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 BU/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either: - i. High FVIII inhibitor titer (\> 5 BU/mL) or - ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL).
Outcome measures
| Measure |
ADVATE - Prophylactic Regimen
n=19 Participants
Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter. Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.
|
MTPs
≤4 previous FVIII exposures
|
|---|---|---|
|
Number of Exposure Days of Treatment With Advate Prior to First Positive Factor VIII (FVIII) Confirmed Inhibitor Assessment
|
14.5 days
Interval 7.0 to 21.0
|
—
|
SECONDARY outcome
Timeframe: 50 exposure days to ADVATEPopulation: Safety Analysis Set
\- High FVIII inhibitor titer (\> 5 Bethesda Unit (BU)/mL) - Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)
Outcome measures
| Measure |
ADVATE - Prophylactic Regimen
n=19 Participants
Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter. Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.
|
MTPs
≤4 previous FVIII exposures
|
|---|---|---|
|
Number of Participants With Low-titer, High-titer, Transient, and All Factor VIII (FVIII) Inhibitors
Low FVIII inhibitor titer
|
5 participants
|
—
|
|
Number of Participants With Low-titer, High-titer, Transient, and All Factor VIII (FVIII) Inhibitors
High FVIII inhibitor titer
|
3 participants
|
—
|
|
Number of Participants With Low-titer, High-titer, Transient, and All Factor VIII (FVIII) Inhibitors
All FVIII inhibitors
|
8 participants
|
—
|
SECONDARY outcome
Timeframe: 50 exposure days to ADVATEPopulation: Safety Analysis Set
Nominal Dosing Frequency: - 1 time per week - 2 times per week - Unknown dosing frequency (UK) Bleeding Type (BT): - Skin - Muscle and Soft Tissue - Mucosal - Joint - Other - Multiple - Total Bleeding severity: - Minor - Moderate - Severe - Total
Outcome measures
| Measure |
ADVATE - Prophylactic Regimen
n=193 Bleeds
Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter. Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.
|
MTPs
≤4 previous FVIII exposures
|
|---|---|---|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Skin; Minor Bleed
|
130 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Skin; Moderate Bleed
|
2 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Skin; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Skin; Total Bleeds
|
132 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Muscle & Soft Tissue; Minor Bleed
|
8 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Muscle & Soft Tissue; Moderate Bleed
|
10 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Muscle & Soft Tissue; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Muscle & Soft Tissue; Total Bleeds
|
18 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Mucosal; Minor Bleed
|
9 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Mucosal; Moderate Bleed
|
3 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Mucosal; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Mucosal; Total Bleeds
|
12 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Joint; Minor Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Joint; Moderate Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Joint; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Joint; Total Bleeds
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Other BT; Minor Bleed
|
3 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Other BT; Moderate Bleed
|
3 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Other BT; Severe Bleed
|
1 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Other BT; Total Bleeds
|
7 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Multiple BT; Minor Bleed
|
2 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Multiple BT; Moderate Bleed
|
1 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Multiple BT; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Multiple BT; Total Bleeds
|
3 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Total BT; Minor Bleed
|
152 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Total BT; Moderate Bleed
|
19 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Total BT; Severe Bleed
|
1 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 1/week; Total BT; Total Bleeds
|
172 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Skin; Minor Bleed
|
9 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Skin; Moderate Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Skin; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Skin; Total Bleeds
|
9 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Muscle & Soft Tissue; Minor Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Muscle & Soft Tissue; Moderate Bleed
|
1 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Muscle & Soft Tissue; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Muscle & Soft Tissue; Total Bleeds
|
1 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Mucosal; Minor Bleed
|
3 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Mucosal; Moderate Bleed
|
1 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Mucosal; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Mucosal; Total Bleeds
|
4 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Joint; Minor Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Joint; Moderate Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Joint; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Joint; Total Bleeds
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Other BT; Minor Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Other BT; Moderate Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Other BT; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Other BT; Total Bleeds
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Multiple BT; Minor Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Multiple BT; Moderate Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Multiple BT; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Multiple BT; Total Bleeds
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Total BT; Minor Bleed
|
12 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Total BT; Moderate Bleed
|
2 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Total BT; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: 2/week; Total BT; Total Bleeds
|
14 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Skin; Minor Bleed
|
4 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Skin; Moderate Bleed
|
1 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Skin; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Skin; Total Bleeds
|
5 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Muscle & Soft Tissue; Minor Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Muscle & Soft Tissue;Moderate Bleed
|
1 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Muscle & Soft Tissue; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Muscle & Soft Tissue; Total Bleeds
|
1 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Mucosal; Minor Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Mucosal; Moderate Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Mucosal; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Mucosal; Total Bleeds
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Joint; Minor Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Joint; Moderate Bleed
|
1 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Joint; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Joint; Total Bleeds
|
1 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Other BT; Minor Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Other BT; Moderate Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Other BT; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Other BT; Total Bleeds
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Multiple BT; Minor Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK/week; Multiple BT; Moderate Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK /week; Multiple BT; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK /week; Multiple BT; Total Bleeds
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK /week; Total BT; Minor Bleed
|
4 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK /week; Total BT; Moderate Bleed
|
3 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK /week; Total BT; Severe Bleed
|
0 Bleeds
|
—
|
|
Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)
Dose: UK /week; Total BT; Total Bleeds
|
7 Bleeds
|
—
|
SECONDARY outcome
Timeframe: 50 exposure days to ADVATEPopulation: Safety Analysis Set
\- Elective surgery is not allowed during period of first 20 exposure days (EDs) - Peripherally inserted central catheter (PICC)
Outcome measures
| Measure |
ADVATE - Prophylactic Regimen
n=19 Participants
Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter. Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.
|
MTPs
≤4 previous FVIII exposures
|
|---|---|---|
|
Number and Type of Surgeries
Surgery: Cimino Shunt
|
1 surgeries
|
—
|
|
Number and Type of Surgeries
Surgery: PICC Line Insertion in right arm
|
1 surgeries
|
—
|
SECONDARY outcome
Timeframe: 50 exposure days to ADVATEPopulation: Due to the low number of subjects available for evaluation, no statistical tests were performed to assess associations between known risk factors to inhibitor formation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 50 exposure days to ADVATEPopulation: Due to the low number of subjects available for evaluation, no statistical tests were performed to assess the total FVIII consumption by participant
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 50 exposure days to ADVATEPopulation: Summary statistics of FVIII-Specific Antibody Isotypes were not performed due to the early termination of the study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 50 exposure days to ADVATEPopulation: Safety Analysis Set
Possibly or probably related adverse events
Outcome measures
| Measure |
ADVATE - Prophylactic Regimen
n=19 Participants
Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter. Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.
|
MTPs
≤4 previous FVIII exposures
|
|---|---|---|
|
Number of Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) at Least Possibly Related to ADVATE
SAEs
|
9 adverse events
|
—
|
|
Number of Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) at Least Possibly Related to ADVATE
non-SAEs
|
1 adverse events
|
—
|
POST_HOC outcome
Timeframe: 50 exposure days to ADVATEPopulation: Safety Analysis Set
'True' positive inhibitor (PI) defined as any FVIII inhibitor assay result ≥0.6 Bethesda Units (BU)/mL confirmed by central lab on 2 consecutive samples, ie ≥2 PI results (including first PI test, in accordance with study protocol) assessed as either: i. High FVIII inhibitor titer (\> 5 BU/mL) ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL). In addition, to be classified as 'true' positive low FVIII inhibitors titer (≥0.6 - ≤5.0 BU/mL), one of following criteria must be met: - a) Lower or absent therapeutic response at infusion of standard replacement doses ("clinically relevant") as deemed by the clinician in charge. - b) Any lab result of binding FVIII antibodies (IgM, IgA, IgG, IgG1, IgG2, IgG3, or IgG4) must be positive. Classification based on first positive FVIII inhibitor assessment. Inhibitor test result is: - \> 5 BU/mL, then categorized as a high-titer inhibitor - ≥0.6 BU/mL but ≤5 BU/mL, then categorized as a low-titer.
Outcome measures
| Measure |
ADVATE - Prophylactic Regimen
n=19 Participants
Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter. Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.
|
MTPs
≤4 previous FVIII exposures
|
|---|---|---|
|
Number of Participants With Factor VIII (FVIII) Inhibitors by Inhibitor Type (Only 'True' Inhibitors)
Inhibitor Type: Low-Titer
|
3 participants
Interval 3.4 to 39.6
|
—
|
|
Number of Participants With Factor VIII (FVIII) Inhibitors by Inhibitor Type (Only 'True' Inhibitors)
Inhibitor Type: High-Titer
|
3 participants
Interval 3.4 to 39.6
|
—
|
|
Number of Participants With Factor VIII (FVIII) Inhibitors by Inhibitor Type (Only 'True' Inhibitors)
Inhibitor Type: All Inhibitors
|
6 participants
Interval 12.6 to 56.6
|
—
|
POST_HOC outcome
Timeframe: 50 exposure days to ADVATEPopulation: Safety Analysis Set
PUPs = no previous FVIII exposure; MTPs ≤4 previous FVIII exposures 'True' positive inhibitor (PI) = any FVIII inhibitor assay result ≥0.6 Bethesda Units (BU)/mL confirmed by central lab on 2 consecutive samples, ie ≥2 PI results (including first PI test, per study protocol) assessed as either: i. High FVIII inhibitor titer (\>5 BU/mL) ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL). In addition, to be classified as 'true' positive low FVIII inhibitors titer (≥0.6 - ≤5.0 BU/mL), one of following criteria must be met: - a) Lower or absent therapeutic response at infusion of standard replacement doses ("clinically relevant") as deemed by clinician in charge. - b) Any lab result of binding FVIII antibodies (IgM, IgA, IgG, IgG1, IgG2, IgG3, or IgG4) must be positive. Classification based on first positive FVIII inhibitor assessment. Inhibitor test result is: - \> 5 BU/mL, categorized as high-titer inhibitor - ≥0.6 BU/mL but ≤5 BU/mL, categorized as low-titer
Outcome measures
| Measure |
ADVATE - Prophylactic Regimen
n=11 Participants
Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter. Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.
|
MTPs
n=8 Participants
≤4 previous FVIII exposures
|
|---|---|---|
|
Number of Inhibitors in Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs) - (Only 'True' Inhibitors)
|
3 inhibitors
|
3 inhibitors
|
Adverse Events
ADVATE - Prophylactic Regimen
Serious events: 11 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ADVATE - Prophylactic Regimen
n=19 participants at risk
Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter. Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.
|
|---|---|
|
Blood and lymphatic system disorders
FACTOR VIII INHIBITION
|
42.1%
8/19 • Number of events 8 • 1 year and 3 months
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
5.3%
1/19 • Number of events 2 • 1 year and 3 months
|
|
Musculoskeletal and connective tissue disorders
SOFT TISSUE HAEMORRHAGE
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Surgical and medical procedures
ARTERIOVENOUS FISTULA OPERATION
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Vascular disorders
HAEMORRHAGE
|
10.5%
2/19 • Number of events 2 • 1 year and 3 months
|
Other adverse events
| Measure |
ADVATE - Prophylactic Regimen
n=19 participants at risk
Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter. Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.
|
|---|---|
|
Blood and lymphatic system disorders
FACTOR VIII INHIBITION (UNCONFIRMED)
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Ear and labyrinth disorders
MIDDLE EAR EFFUSION
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Eye disorders
EYE DISCHARGE
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Eye disorders
LACRIMATION INCREASED
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
15.8%
3/19 • Number of events 3 • 1 year and 3 months
|
|
Gastrointestinal disorders
TEETHING
|
21.1%
4/19 • Number of events 10 • 1 year and 3 months
|
|
Gastrointestinal disorders
VOMITING
|
26.3%
5/19 • Number of events 6 • 1 year and 3 months
|
|
General disorders
PYREXIA
|
52.6%
10/19 • Number of events 13 • 1 year and 3 months
|
|
Immune system disorders
FOOD ALLERGY
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Infections and infestations
ACUTE TONSILLITIS
|
5.3%
1/19 • Number of events 2 • 1 year and 3 months
|
|
Infections and infestations
BRONCHITIS
|
5.3%
1/19 • Number of events 2 • 1 year and 3 months
|
|
Infections and infestations
CANDIDIASIS
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Infections and infestations
COXSACKIE VIRAL INFECTION
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Infections and infestations
EAR INFECTION
|
10.5%
2/19 • Number of events 2 • 1 year and 3 months
|
|
Infections and infestations
GASTROENTERITIS
|
5.3%
1/19 • Number of events 2 • 1 year and 3 months
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Infections and infestations
HORDEOLUM
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Infections and infestations
NASOPHARYNGITIS
|
31.6%
6/19 • Number of events 7 • 1 year and 3 months
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Infections and infestations
RHINITIS
|
42.1%
8/19 • Number of events 13 • 1 year and 3 months
|
|
Infections and infestations
TONSILLITIS
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
15.8%
3/19 • Number of events 7 • 1 year and 3 months
|
|
Infections and infestations
VIRAL INFECTION
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Injury, poisoning and procedural complications
FACE INJURY
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Injury, poisoning and procedural complications
FALL
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Injury, poisoning and procedural complications
LIP INJURY
|
5.3%
1/19 • Number of events 2 • 1 year and 3 months
|
|
Injury, poisoning and procedural complications
TONGUE INJURY
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Injury, poisoning and procedural complications
VACCINATION COMPLICATION
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Injury, poisoning and procedural complications
WRONG DRUG ADMINISTERED
|
5.3%
1/19 • Number of events 3 • 1 year and 3 months
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Musculoskeletal and connective tissue disorders
JOINT RANGE OF MOTION DECREASED
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
31.6%
6/19 • Number of events 6 • 1 year and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DRYNESS
|
5.3%
1/19 • Number of events 2 • 1 year and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
10.5%
2/19 • Number of events 3 • 1 year and 3 months
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Skin and subcutaneous tissue disorders
DERMATITIS DIAPER
|
5.3%
1/19 • Number of events 5 • 1 year and 3 months
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Skin and subcutaneous tissue disorders
RASH
|
15.8%
3/19 • Number of events 3 • 1 year and 3 months
|
|
Vascular disorders
HAEMATOMA
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
|
Vascular disorders
VASCULAR RUPTURE
|
5.3%
1/19 • Number of events 1 • 1 year and 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Agreements may vary with individual PIs, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or up to 2 years after study completion. Baxter requires a review of results communications (eg for confidential information) ≥30 days prior to submission/communication. Baxter may request additional delay of ≤6 months (e.g., for intellectual property protection). Prior authorization may be required
- Publication restrictions are in place
Restriction type: OTHER