Trial Outcomes & Findings for Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings (NCT NCT00884390)
NCT ID: NCT00884390
Last Updated: 2014-09-01
Results Overview
Number of participants with clinically significant FVIII inhibitor development after switching from ReFacto to moroctocog alfa (AF-CC). Clinically significant inhibitors are defined as a central laboratory confirmed positive inhibitor (≥ 0.6 Bethesda unit (BU) using the Nijmegen modification of the Bethesda assay present at 2 consecutive blood draws within a 6-week interval) and within 28 days before the initial or within 28 days following the second positive FVIII inhibitor sample collection one of the following: the need for the participant to administer alternative hemostatic products in order to achieve sufficient efficacy, or ≥2 adverse event reports of decreased drug effect (or other adverse event indicating a decrease in the efficacy of the test article). The blood sample collection for these results must also be between the date of first dose of study medication and 28 days after the last dose of study medication.
TERMINATED
PHASE4
208 participants
100 exposure days to study medication (approx. 2 years)
2014-09-01
Participant Flow
Two hundred and eight (208) participants were enrolled into the study (146 participants into the ReFacto Switch group \[Cohort 1: participants who switched from ReFacto to ReFacto AF\] and 62 participants into the Other Switch group \[Cohort 2: participants who switched from other Factor VIII (FVIII) products other than ReFacto to ReFacto AF\]).
Participant milestones
| Measure |
ReFacto Switch
Participants who switched from ReFacto to ReFacto AF
|
Other Switch
Participants who switched from other FVIII products other than ReFacto to ReFacto AF
|
|---|---|---|
|
Overall Study
STARTED
|
146
|
62
|
|
Overall Study
COMPLETED
|
123
|
54
|
|
Overall Study
NOT COMPLETED
|
23
|
8
|
Reasons for withdrawal
| Measure |
ReFacto Switch
Participants who switched from ReFacto to ReFacto AF
|
Other Switch
Participants who switched from other FVIII products other than ReFacto to ReFacto AF
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Protocol Violation
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Discontinuation of Study by Sponsor
|
2
|
2
|
|
Overall Study
Other
|
11
|
1
|
Baseline Characteristics
Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings
Baseline characteristics by cohort
| Measure |
ReFacto Switch
n=146 Participants
Participants who switched from ReFacto to ReFacto AF
|
Other Switch
n=62 Participants
Participants who switched from other FVIII products other than ReFacto to ReFacto AF
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
12-17 years
|
33 participants
n=5 Participants
|
9 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Age, Customized
18-65 years
|
113 participants
n=5 Participants
|
53 participants
n=7 Participants
|
166 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 exposure days to study medication (approx. 2 years)Population: All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.
Number of participants with clinically significant FVIII inhibitor development after switching from ReFacto to moroctocog alfa (AF-CC). Clinically significant inhibitors are defined as a central laboratory confirmed positive inhibitor (≥ 0.6 Bethesda unit (BU) using the Nijmegen modification of the Bethesda assay present at 2 consecutive blood draws within a 6-week interval) and within 28 days before the initial or within 28 days following the second positive FVIII inhibitor sample collection one of the following: the need for the participant to administer alternative hemostatic products in order to achieve sufficient efficacy, or ≥2 adverse event reports of decreased drug effect (or other adverse event indicating a decrease in the efficacy of the test article). The blood sample collection for these results must also be between the date of first dose of study medication and 28 days after the last dose of study medication.
Outcome measures
| Measure |
All Participants With at Least One Prophylaxis Infusion
n=146 Participants
All enrolled participants with at least one prophylaxis infusion
|
Other Switch
n=62 Participants
Participants who switched from other FVIII products other than ReFacto to ReFacto AF
|
|---|---|---|
|
Number of Participants With Clinically Significant Factor VIII Inhibitor Development
|
0 Number of participants
Interval 0.0 to 2.49
|
0 Number of participants
Interval 0.0 to 5.78
|
SECONDARY outcome
Timeframe: 100 exposure days to study medication (approx. 2 years)Population: All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.
An ABR for each participant will be calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the Infusion Log Diary case report form), divided by his total therapy duration (in days), then multiplied by 365.25.
Outcome measures
| Measure |
All Participants With at Least One Prophylaxis Infusion
n=208 Participants
All enrolled participants with at least one prophylaxis infusion
|
Other Switch
Participants who switched from other FVIII products other than ReFacto to ReFacto AF
|
|---|---|---|
|
Annualized Bleeding Rates (ABRs)
On-demand regimen (N=52)
|
28.35 Number of bleeds
Standard Deviation 18.781
|
—
|
|
Annualized Bleeding Rates (ABRs)
Preventive regimen (N=2)
|
1.08 Number of bleeds
Standard Deviation 1.528
|
—
|
|
Annualized Bleeding Rates (ABRs)
Primary or secondary prophylaxis regimen (N=154)
|
8.43 Number of bleeds
Standard Deviation 17.362
|
—
|
SECONDARY outcome
Timeframe: 100 exposure days to study medication (approx. 2 years)Population: All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.
A 4-point scale of assessment of 'on-demand' treatment (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) is defined as: * Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. * Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least one additional infusion administered for complete resolution of the bleeding episode; or, Definite pain relief and/or improvement in signs of bleeding starting after 8 hours following the infusion, with no additional infusion administered. * Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least one additional infusion administered for complete resolution of the bleeding episode. * No Response: No improvement at all between infusions or during the 24-hour interval following an infusion, or condition worsens.
Outcome measures
| Measure |
All Participants With at Least One Prophylaxis Infusion
n=156 Participants
All enrolled participants with at least one prophylaxis infusion
|
Other Switch
Participants who switched from other FVIII products other than ReFacto to ReFacto AF
|
|---|---|---|
|
Response Assessment of First On-demand Treatment of New Bleeds
Excellent
|
1650 Number of observations
|
—
|
|
Response Assessment of First On-demand Treatment of New Bleeds
Good
|
1031 Number of observations
|
—
|
|
Response Assessment of First On-demand Treatment of New Bleeds
Moderate
|
191 Number of observations
|
—
|
|
Response Assessment of First On-demand Treatment of New Bleeds
No response
|
26 Number of observations
|
—
|
|
Response Assessment of First On-demand Treatment of New Bleeds
Data Not Recorded
|
343 Number of observations
|
—
|
|
Response Assessment of First On-demand Treatment of New Bleeds
Total
|
3241 Number of observations
|
—
|
SECONDARY outcome
Timeframe: 100 exposure days to study medication (approx. 2 years)Population: All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.
The Infusion Log Diary case report form (CRF) was used to determine the number of test article infusions administered to treat a bleed. This was calculated by adding the initial (on-demand) infusion to any subsequent (on-demand) infusions for the same bleed (same bleed start date/time).
Outcome measures
| Measure |
All Participants With at Least One Prophylaxis Infusion
n=156 Participants
All enrolled participants with at least one prophylaxis infusion
|
Other Switch
Participants who switched from other FVIII products other than ReFacto to ReFacto AF
|
|---|---|---|
|
Number of ReFacto AF Infusions to Treat Each New Bleed
Excellent
|
1.1 Number of Infusions
Standard Deviation 0.66
|
—
|
|
Number of ReFacto AF Infusions to Treat Each New Bleed
Good
|
1.4 Number of Infusions
Standard Deviation 1.45
|
—
|
|
Number of ReFacto AF Infusions to Treat Each New Bleed
Moderate
|
2.0 Number of Infusions
Standard Deviation 1.63
|
—
|
|
Number of ReFacto AF Infusions to Treat Each New Bleed
No response
|
2.5 Number of Infusions
Standard Deviation 2.60
|
—
|
|
Number of ReFacto AF Infusions to Treat Each New Bleed
Data Not Recorded
|
1.3 Number of Infusions
Standard Deviation 1.55
|
—
|
SECONDARY outcome
Timeframe: 100 exposure days to study medication (approx. 2 years)Population: All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.
First, the bleed start time from the Infusion Log Diary CRF was used to determine the number of breakthrough bleeds that occurred ≤48 hours after an infusion marked as "Prophylaxis" (which had no associated bleed). If there was more than 1 bleed location (ie, ankle and joint) with identical bleed start date and time, it was treated as 1 bleed occurrence. If a response was given, or if a bleed time was given, but "On Demand" was not listed as "treatment type", it was still counted as an on-demand bleed for analyses/summaries. Bleeding episodes were not categorized as spontaneous (atraumatic) or traumatic.
Outcome measures
| Measure |
All Participants With at Least One Prophylaxis Infusion
n=108 Participants
All enrolled participants with at least one prophylaxis infusion
|
Other Switch
Participants who switched from other FVIII products other than ReFacto to ReFacto AF
|
|---|---|---|
|
Number of Bleeding Episodes Occurring ≤48 Hours After a Prophylaxis Infusion
|
96 bleeds
|
—
|
SECONDARY outcome
Timeframe: 100 exposure days to study medication (approx. 2 years)Population: All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.
The number of participants with any breakthrough bleed was reported.
Outcome measures
| Measure |
All Participants With at Least One Prophylaxis Infusion
n=108 Participants
All enrolled participants with at least one prophylaxis infusion
|
Other Switch
Participants who switched from other FVIII products other than ReFacto to ReFacto AF
|
|---|---|---|
|
Number of Participants With Breakthrough Bleeds
|
33 participants
|
—
|
SECONDARY outcome
Timeframe: 100 exposure days to study medication (approx. 2 years)Population: All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.
The total amount (in International Units \[IU\]) infused for each test article infusion recorded in the Infusion Log Diary CRF was summed to calculate the TFC for each participant.
Outcome measures
| Measure |
All Participants With at Least One Prophylaxis Infusion
n=54 Participants
All enrolled participants with at least one prophylaxis infusion
|
Other Switch
Participants who switched from other FVIII products other than ReFacto to ReFacto AF
|
|---|---|---|
|
Total Factor Consumption (TFC) Following a Non-prophylaxis Regimen at Baseline for All Participants
On demand (n=50)
|
115451.5 International Units (IU)
Standard Deviation 67186.92
|
—
|
|
Total Factor Consumption (TFC) Following a Non-prophylaxis Regimen at Baseline for All Participants
Preventive (n=43)
|
35156.8 International Units (IU)
Standard Deviation 40690.91
|
—
|
|
Total Factor Consumption (TFC) Following a Non-prophylaxis Regimen at Baseline for All Participants
Prophylaxis (n=19)
|
73001.9 International Units (IU)
Standard Deviation 66969.64
|
—
|
|
Total Factor Consumption (TFC) Following a Non-prophylaxis Regimen at Baseline for All Participants
Not specified (n=54)
|
39268.3 International Units (IU)
Standard Deviation 65013.77
|
—
|
|
Total Factor Consumption (TFC) Following a Non-prophylaxis Regimen at Baseline for All Participants
Total (n=54)
|
199848.9 International Units (IU)
Standard Deviation 79308.82
|
—
|
SECONDARY outcome
Timeframe: 100 exposure days to study medication (approx. 2 years)Population: All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.
The total amount (in IU) infused for each test article infusion recorded in the Infusion Log Diary CRF was summed to calculate the TFC for each participant.
Outcome measures
| Measure |
All Participants With at Least One Prophylaxis Infusion
n=154 Participants
All enrolled participants with at least one prophylaxis infusion
|
Other Switch
Participants who switched from other FVIII products other than ReFacto to ReFacto AF
|
|---|---|---|
|
TFC Following a Prophylaxis Regimen at Baseline for All Participants
On Demand (n=98)
|
26063.4 IU
Standard Deviation 32876.96
|
—
|
|
TFC Following a Prophylaxis Regimen at Baseline for All Participants
Preventive (n=65)
|
22498.8 IU
Standard Deviation 29987.52
|
—
|
|
TFC Following a Prophylaxis Regimen at Baseline for All Participants
Prophylaxis (n=143)
|
165124.6 IU
Standard Deviation 88373.55
|
—
|
|
TFC Following a Prophylaxis Regimen at Baseline for All Participants
Not specified (n=154)
|
43812.8 IU
Standard Deviation 67588.23
|
—
|
|
TFC Following a Prophylaxis Regimen at Baseline for All Participants
Total (n=154)
|
223224.8 IU
Standard Deviation 86493.58
|
—
|
SECONDARY outcome
Timeframe: 100 exposure days to study medication (approx. 2 years)Population: All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.
The average infusion dose for each participant was calculated as his total factor consumption (in IU) divided by the number of infusions administered. Summary statistics were reported for both of these variables separately for those participants classified at baseline as following an on-demand regimen, and for those on a primary or secondary prophylaxis regimen.
Outcome measures
| Measure |
All Participants With at Least One Prophylaxis Infusion
n=54 Participants
All enrolled participants with at least one prophylaxis infusion
|
Other Switch
n=154 Participants
Participants who switched from other FVIII products other than ReFacto to ReFacto AF
|
|---|---|---|
|
Average Infusion Dose
|
2326.8 IU
Standard Deviation 691.31
|
2290.3 IU
Standard Deviation 701.36
|
SECONDARY outcome
Timeframe: 100 exposure days to study medication (approx. 2 years)Population: All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.
The calculation of incidence of on-demand LETE used the number of bleeds identified as, or with a result of, LETE as the numerator (from the On Demand LETE CRF), and the denominator was the number of bleeding episodes treated in an on-demand setting. This denominator could include new bleeding episodes in prophylaxis participants breakthrough bleeds), and if subsequent on-demand doses for such a bleed met the on-demand LETE criteria, then an on-demand LETE was reported.
Outcome measures
| Measure |
All Participants With at Least One Prophylaxis Infusion
n=208 Participants
All enrolled participants with at least one prophylaxis infusion
|
Other Switch
Participants who switched from other FVIII products other than ReFacto to ReFacto AF
|
|---|---|---|
|
Incidence of Less-than-expected-therapeutic Effect (LETE) in the On-demand Setting
|
0.06 percentage of bleeds LETE
Interval 0.01 to 0.22
|
—
|
SECONDARY outcome
Timeframe: 100 exposure days to study medication (approx. 2 years)The calculation of incidence of prophylaxis LETE used the number of bleeds identified as, or with a result of, LETE as the numerator (from the Prophylactic LETE CRF), and the denominator was the number of routine prophylaxis infusions. Each infusion was classified in the infusion log ("Prophylaxis/ On Demand/ Preventive"), and participants were instructed to select "On Demand" if the infusion was to treat a bleed, even if the participant typically followed a prophylaxis regimen. Only the infusions classified as "Prophylaxis" were counted in this denominator.
Outcome measures
| Measure |
All Participants With at Least One Prophylaxis Infusion
n=208 Participants
All enrolled participants with at least one prophylaxis infusion
|
Other Switch
Participants who switched from other FVIII products other than ReFacto to ReFacto AF
|
|---|---|---|
|
Incidence of Less-than-expected-therapeutic Effect (LETE) in the Prophylaxis Setting
|
0.19 percentage of bleeding episodes
Interval 0.12 to 0.28
|
—
|
Adverse Events
All Participants
Serious adverse events
| Measure |
All Participants
n=208 participants at risk
The primary safety analysis was performed on all subjects who received at least 1 dose of ReFacto AF.
|
|---|---|
|
Blood and lymphatic system disorders
Factor VIII inhibition
|
2.4%
5/208 • Number of events 5 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haematemesis
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Intestinal haematoma
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Acute tonsillitis
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Post procedural infection
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Septic arthritis streptococcal
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.48%
1/208 • Number of events 2 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Photophobia
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Visual impairment
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chills
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pain
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Anti factor VIII antibody positive
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.48%
1/208 • Number of events 1 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
All Participants
n=208 participants at risk
The primary safety analysis was performed on all subjects who received at least 1 dose of ReFacto AF.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
15.4%
32/208 • Number of events 44 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
6.2%
13/208 • Number of events 18 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
26/208 • Number of events 69 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
11.5%
24/208 • Number of events 86 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
7.2%
15/208 • Number of events 25 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
10.1%
21/208 • Number of events 47 • Duration of participation in study
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER