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Trial record 1 of 1 for:    NCT00895037
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Study Evaluating Pharmacovigilance Of Refacto AF

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ClinicalTrials.gov Identifier: NCT00895037
Recruitment Status : Completed
First Posted : May 7, 2009
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hemophilia A
Intervention Drug: ReFacto AF (Moroctocog alfa)
Enrollment 101
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ReFacto AF: On Demand Treatment ReFacto AF: Prophylaxis Treatment ReFacto AF: Intermediate Prophylaxis Treatment
Hide Arm/Group Description Participants were treated with intravenous (IV) injection of ReFacto AF whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 23.0 ± 8.0 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 87 months in this study. Participants were treated prophylactically with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study. Participants had intermediate prophylaxis (regular dosing with drug at a low dose than the defined prophylactic treatment) treatment with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of less than [>] 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Period Title: Overall Study
Started 22 77 2
Completed 22 75 1
Not Completed 0 2 1
Reason Not Completed
Death             0             2             1
Arm/Group Title ReFacto AF: On Demand Treatment ReFacto AF: Prophylaxis Treatment ReFacto AF: Intermediate Prophylaxis Treatment Total
Hide Arm/Group Description Participants were treated with intravenous (IV) injection of ReFacto AF whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 23.0 ± 8.0 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 87 months in this study. Participants were treated prophylactically with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study. Participants had intermediate prophylaxis (regular dosing with drug at a low dose than the defined prophylactic treatment) treatment with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of less than [>] 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study. Total of all reporting groups
Overall Number of Baseline Participants 22 77 2 101
Hide Baseline Analysis Population Description
Safety analysis set included all participants with informed consent and treated with at least 1 dose of ReFacto AF.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 77 participants 2 participants 101 participants
34.0  (20.2) 18.5  (12.4) 62.0  (7.1) 22.7  (16.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 77 participants 2 participants 101 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
22
 100.0%
77
 100.0%
2
 100.0%
101
 100.0%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 87 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Time Frame Baseline until last visit (up to 87 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants with informed consent and treated with at least 1 dose of ReFacto AF.
Arm/Group Title ReFacto AF: On Demand Treatment ReFacto AF: Prophylaxis Treatment ReFacto AF: Intermediate Prophylaxis Treatment
Hide Arm/Group Description:
Participants were treated with intravenous (IV) injection of ReFacto AF whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 23.0 ± 8.0 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 87 months in this study.
Participants were treated prophylactically with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Participants had intermediate prophylaxis (regular dosing with drug at a low dose than the defined prophylactic treatment) treatment with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of less than [>] 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Overall Number of Participants Analyzed 22 77 2
Measure Type: Number
Unit of Measure: participants
AEs 15 59 2
SAEs 7 25 2
2.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; cancer; congenital anomaly. AEs included both serious and non-serious adverse events. Relatedness of AEs with Refacto AF was assessed by the investigator.
Time Frame Baseline until last visit (up to 87 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants with informed consent and treated with at least 1 dose of ReFacto AF.
Arm/Group Title ReFacto AF: On Demand Treatment ReFacto AF: Prophylaxis Treatment ReFacto AF: Intermediate Prophylaxis Treatment
Hide Arm/Group Description:
Participants were treated with intravenous (IV) injection of ReFacto AF whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 23.0 ± 8.0 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 87 months in this study.
Participants were treated prophylactically with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Participants had intermediate prophylaxis (regular dosing with drug at a low dose than the defined prophylactic treatment) treatment with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of less than [>] 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Overall Number of Participants Analyzed 22 77 2
Measure Type: Number
Unit of Measure: participants
AEs 2 7 0
SAEs 0 0 0
3.Primary Outcome
Title Number of Participants With Factor VIII (FVIII) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay
Hide Description FVIII inhibitor development was defined as measured inhibitor titer of greater than (>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.
Time Frame Baseline until last visit (up to 87 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants with informed consent and treated with at least 1 dose of ReFacto AF.
Arm/Group Title ReFacto AF: On Demand Treatment ReFacto AF: Prophylaxis Treatment ReFacto AF: Intermediate Prophylaxis Treatment
Hide Arm/Group Description:
Participants were treated with intravenous (IV) injection of ReFacto AF whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 23.0 ± 8.0 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 87 months in this study.
Participants were treated prophylactically with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Participants had intermediate prophylaxis (regular dosing with drug at a low dose than the defined prophylactic treatment) treatment with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of less than [>] 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Overall Number of Participants Analyzed 22 77 2
Measure Type: Number
Unit of Measure: participants
1 2 0
4.Primary Outcome
Title Mean Total Number of Bleeding Episodes in Participants
Hide Description Participants documented all bleeding episodes in a diary during the study.
Time Frame Baseline until last visit (up to 87 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness analysis set =participants registered in study and had at least 1 dose of ReFacto AF documented by participants diary entries. Participant’s registration included confirmation of obtained participant’s informed consent from the physician. Here, 'N' (number of participants analyzed) = participants evaluable for this outcome measure.
Arm/Group Title ReFacto AF: On Demand Treatment ReFacto AF: Prophylaxis Treatment ReFacto AF: Intermediate Prophylaxis Treatment
Hide Arm/Group Description:
Participants were treated with intravenous (IV) injection of ReFacto AF whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 23.0 ± 8.0 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 87 months in this study.
Participants were treated prophylactically with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Participants had intermediate prophylaxis (regular dosing with drug at a low dose than the defined prophylactic treatment) treatment with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of less than [>] 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Overall Number of Participants Analyzed 17 74 2
Mean (Standard Deviation)
Unit of Measure: bleeding episodes
71.2  (73.3) 15.4  (14.7) 68.5  (31.8)
5.Secondary Outcome
Title Mean Total Number of Bleeding Episodes Per Year in Participants
Hide Description Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated as: mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation.
Time Frame Baseline until last visit (up to 87 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness analysis set =participants registered in study and had at least 1 dose of ReFacto AF documented by participants diary entries. Participant’s registration included confirmation of obtained participant’s informed consent from the physician. Here, 'N' =participants evaluable for this outcome measure.
Arm/Group Title ReFacto AF: On Demand Treatment ReFacto AF: Prophylaxis Treatment ReFacto AF: Intermediate Prophylaxis Treatment
Hide Arm/Group Description:
Participants were treated with intravenous (IV) injection of ReFacto AF whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 23.0 ± 8.0 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 87 months in this study.
Participants were treated prophylactically with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Participants had intermediate prophylaxis (regular dosing with drug at a low dose than the defined prophylactic treatment) treatment with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of less than [>] 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Overall Number of Participants Analyzed 17 74 2
Mean (Standard Deviation)
Unit of Measure: bleeding episodes per year
18.6  (19.6) 5.1  (5.8) 13.4  (0.5)
6.Secondary Outcome
Title Number of Participants With Change From Baseline Status in Days Missed From School or Work
Hide Description Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening. Improvement defined as a decrease in number of days missed by participants from school/work as compared to baseline; worsening was defined as an increase in number of days missed by participants from school/work as compared to baseline; unchanged was defined as no change in number of days missed by participants from school/work as compared to baseline. In this outcome measure, number of participants with change from baseline status (as improved, worsen, unchanged) in days missed from school/work were reported.
Time Frame Baseline until last visit (up to 87 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on effectiveness analysis set. Here, 'N' signifies those participants who were evaluable for this outcome measure. For this outcome measure, data for Refacto AF: intermediate prophylaxis treatment arm could not be analyzed since all participants of this arm were neither working nor school going.
Arm/Group Title ReFacto AF: On Demand Treatment ReFacto AF: Prophylaxis Treatment
Hide Arm/Group Description:
Participants were treated with intravenous (IV) injection of ReFacto AF whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 23.0 ± 8.0 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 87 months in this study.
Participants were treated prophylactically with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Overall Number of Participants Analyzed 11 60
Measure Type: Number
Unit of Measure: participants
Improvement 4 25
Unchanged 4 29
Worsening 3 6
7.Secondary Outcome
Title Participant Assessment of Satisfaction With Treatment Handling
Hide Description Participants evaluated their satisfaction with handing (administration) of Refacto AF and rated it in 4 categories as: very satisfied, satisfied, unsatisfied and very unsatisfied.
Time Frame End of study visit (any time up to 87 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness analysis set =participants registered in study and had at least 1 dose of ReFacto AF documented by participants diary entries. Participant’s registration included confirmation of obtained participant’s informed consent from the physician. Here, 'N' =participants evaluable for this outcome measure.
Arm/Group Title ReFacto AF: On Demand Treatment ReFacto AF: Prophylaxis Treatment ReFacto AF: Intermediate Prophylaxis Treatment
Hide Arm/Group Description:
Participants were treated with intravenous (IV) injection of ReFacto AF whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 23.0 ± 8.0 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 87 months in this study.
Participants were treated prophylactically with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Participants had intermediate prophylaxis (regular dosing with drug at a low dose than the defined prophylactic treatment) treatment with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of less than [>] 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Overall Number of Participants Analyzed 18 74 2
Measure Type: Number
Unit of Measure: participants
Very satisfied 13 42 0
Satisfied 5 28 2
Unsatisfied 0 4 0
Very unsatisfied 0 0 0
8.Secondary Outcome
Title Investigator Assessment of Treatment Satisfaction of Participants
Hide Description Investigator assessed the treatment satisfaction of participants and categorized as very satisfied, satisfied, unsatisfied, or very unsatisfied.
Time Frame End of study visit (any time up to 87 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness analysis set =participants registered in study and had at least 1 dose of ReFacto AF documented by participants diary entries. Participant’s registration included confirmation of obtained participant’s informed consent from the physician. Here, 'N' =participants evaluable for this outcome measure.
Arm/Group Title ReFacto AF: On Demand Treatment ReFacto AF: Prophylaxis Treatment ReFacto AF: Intermediate Prophylaxis Treatment
Hide Arm/Group Description:
Participants were treated with intravenous (IV) injection of ReFacto AF whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 23.0 ± 8.0 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 87 months in this study.
Participants were treated prophylactically with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Participants had intermediate prophylaxis (regular dosing with drug at a low dose than the defined prophylactic treatment) treatment with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of less than [>] 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
Overall Number of Participants Analyzed 17 74 2
Measure Type: Number
Unit of Measure: participants
Very satisfied 13 44 0
Satisfied 4 29 2
Unsatisfied 0 1 0
Very unsatisfied 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
 
Arm/Group Title ReFacto AF: On Demand Treatment ReFacto AF: Prophylaxis Treatment ReFacto AF: Intermediate Prophylaxis Treatment
Hide Arm/Group Description Participants were treated with intravenous (IV) injection of ReFacto AF whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 23.0 ± 8.0 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 87 months in this study. Participants were treated prophylactically with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study. Participants had intermediate prophylaxis (regular dosing with drug at a low dose than the defined prophylactic treatment) treatment with a regular IV injection of ReFacto AF to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of less than [>] 26.7 ± 8.4 IU/kg). Participants were observed for up to a maximum duration of 87 months in this study.
All-Cause Mortality
ReFacto AF: On Demand Treatment ReFacto AF: Prophylaxis Treatment ReFacto AF: Intermediate Prophylaxis Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ReFacto AF: On Demand Treatment ReFacto AF: Prophylaxis Treatment ReFacto AF: Intermediate Prophylaxis Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/22 (31.82%)   25/77 (32.47%)   2/2 (100.00%) 
Blood and lymphatic system disorders       
Lymphadenitis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Congenital, familial and genetic disorders       
Phimosis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Eye disorders       
Retinal detachment * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Gastrointestinal disorders       
Duodenal ulcer * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Duodenitis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Gastric polyps * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Gastrointestinal haemorrhage * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Inguinal hernia * 1  1/22 (4.55%)  1/77 (1.30%)  0/2 (0.00%) 
Oesophageal polyp * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Tongue haemorrhage * 1  1/22 (4.55%)  1/77 (1.30%)  0/2 (0.00%) 
Upper gastrointestinal haemorrhage * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Varices oesophageal * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Vomiting * 1  0/22 (0.00%)  1/77 (1.30%)  1/2 (50.00%) 
General disorders       
Disease progression * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Multiple organ dysfunction syndrome * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Hepatobiliary disorders       
Hepatic cirrhosis * 1  0/22 (0.00%)  1/77 (1.30%)  1/2 (50.00%) 
Infections and infestations       
Appendicitis * 1  0/22 (0.00%)  3/77 (3.90%)  0/2 (0.00%) 
Gastroenteritis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Gastrointestinal infection * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Infection * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Intervertebral discitis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Pilonidal cyst * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Pneumonia * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Sepsis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Injury, poisoning and procedural complications       
Craniocerebral injury * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Eye injury * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Fall * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Foot fracture * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Laceration * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Investigations       
Inhibiting antibodies positive * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Haemophilic arthropathy * 1  1/22 (4.55%)  0/77 (0.00%)  1/2 (50.00%) 
Intervertebral disc protrusion * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Joint adhesion * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Muscle spasms * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Osteoarthritis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Osteochondrosis * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Osteonecrosis * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Spondylolisthesis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anogenital warts * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Basal cell carcinoma * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Cholesteatoma * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Lip and/or oral cavity cancer * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Nervous system disorders       
Cerebral haemorrhage * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Epilepsy * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Psychiatric disorders       
Adjustment disorder with depressed mood * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Antisocial personality disorder * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Apathy * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Personality disorder * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Renal and urinary disorders       
Haematuria * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Hydronephrosis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Tonsillar hypertrophy * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders       
Ingrowing nail * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Vascular disorders       
Haematoma * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Haemorrhage * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ReFacto AF: On Demand Treatment ReFacto AF: Prophylaxis Treatment ReFacto AF: Intermediate Prophylaxis Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/22 (63.64%)   56/77 (72.73%)   2/2 (100.00%) 
Blood and lymphatic system disorders       
Iron deficiency anaemia * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Platelet disorder * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Spontaneous haemorrhage * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Thrombocytopenia * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Cardiac disorders       
Palpitations * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Congenital, familial and genetic disorders       
Factor V deficiency * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Ear and labyrinth disorders       
Middle ear inflammation * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Tinnitus * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Endocrine disorders       
Hyperparathyroidism secondary * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Eye disorders       
Eye swelling * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Eyelid oedema * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Retinal detachment * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Visual impairment * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Gastrointestinal disorders       
Abdominal distension * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Abdominal pain * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Abdominal pain upper * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Abdominal tenderness * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Diarrhoea * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Dry mouth * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Dyspepsia  1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Gingival bleeding * 1  1/22 (4.55%)  1/77 (1.30%)  0/2 (0.00%) 
Haematochezia * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Haemorrhoidal haemorrhage * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Haemorrhoids * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Haemorrhoids thrombosed * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Nausea * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Tongue haemorrhage * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Varices oesophageal * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Vomiting * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
General disorders       
Chest pain * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Cyst * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Gait disturbance * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Local swelling * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Pain * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Peripheral swelling * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Pyrexia * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Catheter site phlebitis * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Hepatobiliary disorders       
Cholestasis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Hepatic cirrhosis * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Cholelithiasis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Immune system disorders       
Seasonal allergy * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Infections and infestations       
Bronchitis * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Febrile infection * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Gastroenteritis * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Gastrointestinal infection * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
H1N1 influenza * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Herpes dermatitis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Infectious mononucleosis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Influenza * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Localised infection * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Oral candidiasis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Oral herpes * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Scarlet fever * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Sinusitis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Tonsillitis * 1  1/22 (4.55%)  2/77 (2.60%)  0/2 (0.00%) 
Upper respiratory tract infection * 1  1/22 (4.55%)  2/77 (2.60%)  0/2 (0.00%) 
Urinary tract infection * 1  2/22 (9.09%)  1/77 (1.30%)  0/2 (0.00%) 
Viral upper respiratory tract infection * 1  1/22 (4.55%)  4/77 (5.19%)  1/2 (50.00%) 
Injury, poisoning and procedural complications       
Abdominal injury * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Accident * 1  1/22 (4.55%)  1/77 (1.30%)  0/2 (0.00%) 
Arthropod bite * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Arthropod sting * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Bone contusion * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Clavicle fracture * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Contusion * 1  6/22 (27.27%)  11/77 (14.29%)  0/2 (0.00%) 
Exposure via father * 1  1/22 (4.55%)  1/77 (1.30%)  0/2 (0.00%) 
Eye injury * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Face injury * 1  0/22 (0.00%)  3/77 (3.90%)  0/2 (0.00%) 
Fall * 1  3/22 (13.64%)  17/77 (22.08%)  0/2 (0.00%) 
Foot fracture * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Genital injury * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Hand fracture * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Head injury * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Humerus fracture * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Joint injury * 1  4/22 (18.18%)  14/77 (18.18%)  0/2 (0.00%) 
Laceration * 1  3/22 (13.64%)  8/77 (10.39%)  0/2 (0.00%) 
Ligament sprain * 1  1/22 (4.55%)  7/77 (9.09%)  0/2 (0.00%) 
Limb crushing injury * 1  1/22 (4.55%)  1/77 (1.30%)  0/2 (0.00%) 
Limb injury * 1  2/22 (9.09%)  13/77 (16.88%)  0/2 (0.00%) 
Lip injury * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Medication error * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Mouth injury * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Muscle strain * 1  1/22 (4.55%)  2/77 (2.60%)  0/2 (0.00%) 
Neck injury * 1  1/22 (4.55%)  1/77 (1.30%)  0/2 (0.00%) 
Post procedural haemorrhage * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Procedural pain * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Road traffic accident * 1  2/22 (9.09%)  0/77 (0.00%)  0/2 (0.00%) 
Skin abrasion * 1  3/22 (13.64%)  1/77 (1.30%)  0/2 (0.00%) 
Soft tissue injury * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Sports injury * 1  1/22 (4.55%)  3/77 (3.90%)  0/2 (0.00%) 
Sunburn * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Tongue injury * 1  1/22 (4.55%)  4/77 (5.19%)  0/2 (0.00%) 
Traumatic haematoma * 1  1/22 (4.55%)  4/77 (5.19%)  0/2 (0.00%) 
Traumatic haemorrhage * 1  3/22 (13.64%)  16/77 (20.78%)  0/2 (0.00%) 
Wound dehiscence * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Wrist fracture * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Investigations       
Blood urine present * 1  0/22 (0.00%)  4/77 (5.19%)  0/2 (0.00%) 
Colonoscopy * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Gout * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Type 2 diabetes mellitus * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Vitamin D deficiency * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  3/22 (13.64%)  12/77 (15.58%)  0/2 (0.00%) 
Arthritis * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Arthropathy * 1  2/22 (9.09%)  1/77 (1.30%)  0/2 (0.00%) 
Back pain * 1  2/22 (9.09%)  3/77 (3.90%)  1/2 (50.00%) 
Bone pain * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Flank pain * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Foot deformity * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Groin pain * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Haemarthrosis * 1  1/22 (4.55%)  15/77 (19.48%)  0/2 (0.00%) 
Haemophilic arthropathy * 1  1/22 (4.55%)  2/77 (2.60%)  0/2 (0.00%) 
Intervertebral disc protrusion * 1  1/22 (4.55%)  1/77 (1.30%)  0/2 (0.00%) 
Joint range of motion decreased * 1  0/22 (0.00%)  3/77 (3.90%)  0/2 (0.00%) 
Joint stiffness * 1  1/22 (4.55%)  1/77 (1.30%)  0/2 (0.00%) 
Joint swelling * 1  0/22 (0.00%)  4/77 (5.19%)  0/2 (0.00%) 
Muscle haemorrhage * 1  1/22 (4.55%)  1/77 (1.30%)  0/2 (0.00%) 
Muscle spasms * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Muscle tightness * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Musculoskeletal chest pain * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Musculoskeletal discomfort * 1  1/22 (4.55%)  1/77 (1.30%)  0/2 (0.00%) 
Musculoskeletal pain * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Musculoskeletal stiffness * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Myalgia * 1  2/22 (9.09%)  0/77 (0.00%)  0/2 (0.00%) 
Neck pain * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Nodal osteoarthritis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Osteoarthritis * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Pain in extremity * 1  4/22 (18.18%)  6/77 (7.79%)  1/2 (50.00%) 
Soft tissue haemorrhage * 1  1/22 (4.55%)  2/77 (2.60%)  0/2 (0.00%) 
Spinal disorder * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Spinal pain * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Tendonitis * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Melanocytic naevus * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Nervous system disorders       
Aphasia * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Dizziness * 1  1/22 (4.55%)  0/77 (0.00%)  1/2 (50.00%) 
Headache * 1  1/22 (4.55%)  2/77 (2.60%)  1/2 (50.00%) 
Memory impairment * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Migraine * 1  1/22 (4.55%)  1/77 (1.30%)  0/2 (0.00%) 
Radiculopathy * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Sciatica * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Tremor * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Product Issues       
Device malfunction * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Psychiatric disorders       
Anxiety * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Anxiety disorder * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Apathy * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Renal and urinary disorders       
Haematuria * 1  1/22 (4.55%)  1/77 (1.30%)  0/2 (0.00%) 
Hydronephrosis * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Nocturia * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Pyelocaliectasis * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  1/22 (4.55%)  2/77 (2.60%)  1/2 (50.00%) 
Dysphonia * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Epistaxis * 1  0/22 (0.00%)  2/77 (2.60%)  0/2 (0.00%) 
Haemoptysis * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Skin and subcutaneous tissue disorders       
Dry skin * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Nail psoriasis * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Night sweats * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Rash * 1  1/22 (4.55%)  2/77 (2.60%)  0/2 (0.00%) 
Skin lesion * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Solar lentigo * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Surgical and medical procedures       
Dental care * 1  1/22 (4.55%)  1/77 (1.30%)  0/2 (0.00%) 
Ear operation * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Eye operation * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Hip arthroplasty * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Rehabilitation therapy * 1  0/22 (0.00%)  1/77 (1.30%)  0/2 (0.00%) 
Surgery * 1  1/22 (4.55%)  0/77 (0.00%)  0/2 (0.00%) 
Tooth extraction * 1  1/22 (4.55%)  3/77 (3.90%)  0/2 (0.00%) 
Wedge resection toenail * 1  0/22 (0.00%)  0/77 (0.00%)  1/2 (50.00%) 
Wisdom teeth removal * 1  1/22 (4.55%)  3/77 (3.90%)  0/2 (0.00%) 
Vascular disorders       
Haematoma * 1  2/22 (9.09%)  5/77 (6.49%)  0/2 (0.00%) 
Haemorrhage * 1  1/22 (4.55%)  6/77 (7.79%)  0/2 (0.00%) 
Hypertension * 1  2/22 (9.09%)  1/77 (1.30%)  0/2 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.0
Prioritization of outcome measures as primary and secondary was based on the study team’s discretion, as it was not specified in source documents.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00895037     History of Changes
Other Study ID Numbers: 3082B2-4420
B1831016 ( Other Identifier: Alias Study Number )
First Submitted: May 1, 2009
First Posted: May 7, 2009
Results First Submitted: September 22, 2017
Results First Posted: July 17, 2018
Last Update Posted: July 17, 2018