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| ID | Type | Description | Link |
|---|---|---|---|
| B1831016 | Other Identifier | Alias Study Number |
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The purpose of this observational study is to describe the incidence of adverse events among patients treated with Refacto AF in usual health care settings in Germany and Austria.
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients treated with Refacto AF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReFacto AF (Moroctocog alfa) | Drug | Patients will be treated with intravenous infusion of ReFacto AF per dosing and frequency as prescribed by the subjects' treating physician. ReFacto AF® will be prescribed in the context of routine clinical practice in Germany and Austria, respectively |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Baseline until last visit (up to 87 months) |
| Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Baseline until last visit (up to 87 months) |
| Number of Participants With Factor VIII (FVIII) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay | FVIII inhibitor development was defined as measured inhibitor titer of greater than (>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay. | Baseline until last visit (up to 87 months) |
| Mean Total Number of Bleeding Episodes in Participants | Participants documented all bleeding episodes in a diary during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Total Number of Bleeding Episodes Per Year in Participants | 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. | Baseline until last visit (up to 87 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with hemophilia A
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH - Univ. Klinikum Graz,Abt. fur Hamatologie | Graz | 8036 | Austria | |||
| Allgemeines Krankenhaus Linz, Kinderklinik |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ReFacto AF: On Demand Treatment | 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. |
| FG001 | ReFacto AF: Prophylaxis Treatment | 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. |
| FG002 | ReFacto AF: Intermediate Prophylaxis Treatment | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included all participants with informed consent and treated with at least 1 dose of ReFacto AF.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ReFacto AF: On Demand Treatment | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Safety analysis set included all participants with informed consent and treated with at least 1 dose of ReFacto AF. | Posted | Number | participants | Baseline until last visit (up to 87 months) |
|
Not provided
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ReFacto AF: On Demand Treatment | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
Prioritization of outcome measures as primary and secondary was based on the study team's discretion, as it was not specified in source documents.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005169 | Factor VIII |
| C427184 | recombinant factor VIII SQ |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
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|
| Baseline until last visit (up to 87 months) |
| Number of Participants With Change From Baseline Status in Days Missed From School or Work | 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. | Baseline until last visit (up to 87 months) |
| Participant Assessment of Satisfaction With Treatment Handling | Participants evaluated their satisfaction with handing (administration) of Refacto AF and rated it in 4 categories as: very satisfied, satisfied, unsatisfied and very unsatisfied. | End of study visit (any time up to 87 months) |
| Investigator Assessment of Treatment Satisfaction of Participants | Investigator assessed the treatment satisfaction of participants and categorized as very satisfied, satisfied, unsatisfied, or very unsatisfied. | End of study visit (any time up to 87 months) |
| Linz |
| 4020 |
| Austria |
| Universitaetsklinik fuer Innere Medizin 1 | Vienna | 1090 | Austria |
| Sonnengesundheitszentrum | München | Bavaria | 80336 | Germany |
| Werlhof-Institut für Haemostaseologie GmbH | Hanover | Lower Saxony | 30159 | Germany |
| Vivantes Klinikum im Friedrichshain | Berlin | 10249 | Germany |
| Klinikum Bremen Mitte | Bremen | 28205 | Germany |
| CRC Coagulation Research Centre GmbH | Duisburg | 47051 | Germany |
| Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie | Düsseldorf | 40225 | Germany |
| Universitaetsklinikum Duesseldorf | Düsseldorf | 40225 | Germany |
| Praxis zur Diagnostik und Therapie Von Blutgerinnungstoerungen | Frankfurt A. M. | 60596 | Germany |
| Praxis fur Kinder- und Jugendmedizin | Grünwald | 82031 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| SRH Kurpfalzkrankenhaus Heidelberg | Heidelberg | 69123 | Germany |
| Donaustrasse 78 | Memmingen | 87700 | Germany |
| Praxis Dr. Autenrieth | Metzingen | 72555 | Germany |
| Hämophilie-Zentrum Rhein Main GmbH | Mörfelden-Walldorf | 64546 | Germany |
| Stauferklinikum Schwaebisch Gmuend | Mutlangen | 73557 | Germany |
| Institut for Thrombophilia and Hemastaseologie | Münster | 48143 | Germany |
| Universität Regensburg | Regensburg | 93042 | Germany |
| Asklepios Fachklinikum Stadtroda GmbH | Stadtroda | 07646 | Germany |
| Klinikum Stuttgart | Stuttgart | 70176 | Germany |
| Universitaetsklinik fuer Kinder- und Jugendmedizin | Tübingen | 72076 | Germany |
| Stiftung Deutsche Klinik fur Diagnostik GmbH | Wiesbaden | 65191 | Germany |
| BG001 | ReFacto AF: Prophylaxis Treatment | 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. |
| BG002 | ReFacto AF: Intermediate Prophylaxis Treatment | 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. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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. |
| OG001 | ReFacto AF: Prophylaxis Treatment | 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. |
| OG002 | ReFacto AF: Intermediate Prophylaxis Treatment | 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. |
|
|
| Primary | Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Safety analysis set included all participants with informed consent and treated with at least 1 dose of ReFacto AF. | Posted | Number | participants | Baseline until last visit (up to 87 months) |
|
|
|
| Primary | Number of Participants With Factor VIII (FVIII) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay | FVIII inhibitor development was defined as measured inhibitor titer of greater than (>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay. | Safety analysis set included all participants with informed consent and treated with at least 1 dose of ReFacto AF. | Posted | Number | participants | Baseline until last visit (up to 87 months) |
|
|
|
| Primary | Mean Total Number of Bleeding Episodes in Participants | Participants documented all bleeding episodes in a diary during the study. | 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. | Posted | Mean | Standard Deviation | bleeding episodes | Baseline until last visit (up to 87 months) |
|
|
|
| Secondary | Mean Total Number of Bleeding Episodes Per Year in Participants | 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. | 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. | Posted | Mean | Standard Deviation | bleeding episodes per year | Baseline until last visit (up to 87 months) |
|
|
|
| Secondary | Number of Participants With Change From Baseline Status in Days Missed From School or Work | 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. | 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. | Posted | Number | participants | Baseline until last visit (up to 87 months) |
|
|
|
| Secondary | Participant Assessment of Satisfaction With Treatment Handling | Participants evaluated their satisfaction with handing (administration) of Refacto AF and rated it in 4 categories as: very satisfied, satisfied, unsatisfied and very unsatisfied. | 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. | Posted | Number | participants | End of study visit (any time up to 87 months) |
|
|
|
| Secondary | Investigator Assessment of Treatment Satisfaction of Participants | Investigator assessed the treatment satisfaction of participants and categorized as very satisfied, satisfied, unsatisfied, or very unsatisfied. | 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. | Posted | Number | participants | End of study visit (any time up to 87 months) |
|
|
|
| 7 |
| 22 |
| 14 |
| 22 |
| EG001 | ReFacto AF: Prophylaxis Treatment | 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. | 25 | 77 | 56 | 77 |
| EG002 | ReFacto AF: Intermediate Prophylaxis Treatment | 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. | 2 | 2 | 2 | 2 |
| Phimosis | Congenital, familial and genetic disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Oesophageal polyp | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Tongue haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Pilonidal cyst | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Eye injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Inhibiting antibodies positive | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Haemophilic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Joint adhesion | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Lip and/or oral cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Antisocial personality disorder | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Apathy | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Personality disorder | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Platelet disorder | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Spontaneous haemorrhage | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Factor V deficiency | Congenital, familial and genetic disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Middle ear inflammation | Ear and labyrinth disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Haemorrhoids thrombosed | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Tongue haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cyst | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Catheter site phlebitis | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| H1N1 influenza | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Herpes dermatitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Infectious mononucleosis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Scarlet fever | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Bone contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Exposure via father | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Eye injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Genital injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Limb crushing injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Medication error | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Mouth injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Neck injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Sports injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Tongue injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Colonoscopy | Investigations | MedDRA 19.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Haemophilic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Nodal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Soft tissue haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Device malfunction | Product Issues | MedDRA 19.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Apathy | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Pyelocaliectasis | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Nail psoriasis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Solar lentigo | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Dental care | Surgical and medical procedures | MedDRA 19.0 | Non-systematic Assessment |
|
| Ear operation | Surgical and medical procedures | MedDRA 19.0 | Non-systematic Assessment |
|
| Eye operation | Surgical and medical procedures | MedDRA 19.0 | Non-systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA 19.0 | Non-systematic Assessment |
|
| Rehabilitation therapy | Surgical and medical procedures | MedDRA 19.0 | Non-systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA 19.0 | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 19.0 | Non-systematic Assessment |
|
| Wedge resection toenail | Surgical and medical procedures | MedDRA 19.0 | Non-systematic Assessment |
|
| Wisdom teeth removal | Surgical and medical procedures | MedDRA 19.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
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.
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011498 |
| Protein Precursors |
| D001685 | Biological Factors |
| Title | Measurements |
|---|---|
|
| Worsening |
|
| Title | Measurements |
|---|---|
|
| Unsatisfied |
|
| Very unsatisfied |
|
| Title | Measurements |
|---|---|
|
| Unsatisfied |
|
| Very unsatisfied |
|