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The purpose of this study is to investigate the effectiveness and safety of treatment with ReFacto under conditions of routine therapy. Furthermore a continuous benefit/risk assessment will be done.
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 |
|---|---|---|---|
| A | Patients with Hemophilia A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moroctocog alfa | Drug | Patients will be treated in accordance with the requirements of the labeling of ReFacto (Moroctocog alfa) in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Bleeding Episodes Per Patient Year | Participants with hemophilia A suffer from a hereditary lack of blood clotting factor VIII. As a consequence, the ability of the blood to coagulate is reduced and bleedings at any site or organ of the body may occur after minor injury or even spontaneously. Predominantly, joints, muscles, and internal organs are affected by bleeding complications. Participants reported the occurrence of each bleeding episode while on study. The bleeding rate for each participant was calculated by number of reported episodes per years on study. | Baseline up to a mean duration of 54 months |
| Mean Number of Bleeding-related Exposure Days Per Patient Year | Exposure days are the number of days of treatment with ReFacto. | Baseline up to a mean duration of 54 months |
| Mean Number of Exposure Days Per Patient Year | Exposure days are the number of days of treatment with ReFacto. | Baseline up to a mean duration of 54 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs are any undesired side effect which occurred in a participant undergoing study treatment independent of whether a correlation with study treatment was suspected or not. SAEs are undesired events which were lethal or life-threatening, made hospitalization or extension of hospital stay necessary, lead to permanent damage with handicap (inability to work), as well as congenital anomalies, malignant disease, or overdosing. Also presence of inhibitors, thrombotic events, erythrocyte agglutination, allergic reactions, less than therapeutic effect, and inhibitor development were considered SAEs. |
Not provided
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 |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Vienna | State of Vienna | A-1090 | Austria | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
The study was terminated January 2010 due to the introduction of a successor product ReFacto® AF.
A total of 288 participants were observed during the study in 48 centers (44 Germany and 4 Austria) from time of First subject first visit May 1999 to Last subject last visit January 2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ReFacto (Moroctocog Alfa) | B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
| Baseline up to a mean duration of 54 months |
| Number of Participants With de Novo Inhibitor Formation | The applied criteria of clinical relevance for de novo inhibitor formation was defined as normal Factor VIII dosage was ineffective to control a bleeding, control of bleeding episodes required increasing Factor VIII dosage, change of concentrate type (administration of activated Prothrombin-Complex Concentrate [aPCC] or recombinant Factor VII [rFVII ]) was needed to stop a bleeding, or change of therapy strategy (intensive prophylaxis or Immune Tolerance Induction [ITI]) was required. | Baseline up to a mean duration of 54 months |
| Mean Annual ReFacto Consumption Per Patient Year | ReFacto administered as International Units (IU) according to the physician's decision following the drug's summary of product characteristics (SPC) and according to usual care principles. | Baseline up to a mean duration of 54 months |
| Number of Participants for Physicians' Assessment of Satisfaction With Treatment Success | Subjective assessment by the physician to evaluate treatment success (i.e., control of bleeding, Factor VIII consumption, treatment efficacy and tolerance, handling of preparation, and days missing from work or school). Physician rated assessment could be categorized as Very satisfied, Satisfied, Unsatisfied, or Very unsatisfied; no criteria was pre-specified for the assessment categories in this observational study. | Baseline up to a mean duration of 54 months |
| Number of Participants for Physicians' Assessment of Efficacy | Subjective assessment by the physician to evaluate control of bleeding. Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study. | Baseline up to a mean duration of 54 months |
| Number of Participants for Patients' Assessment of Efficacy | Subjective assessment by the participant to evaluate control of bleeding. Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study. | Baseline up to a mean duration of 54 months |
| Number of Participants for Physicians' Assessment of Tolerance | Subjective assessment by the physician to evaluate the participants' tolerance of treatment with ReFacto (i.e., dose, administration method, or adverse effects). Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study. | Baseline up to a mean duration of 54 months |
| Number of Participants for Patients' Assessment of Tolerance | Subjective assessment by the participant to evaluate tolerance of treatment with ReFacto (i.e., dose, administration method, or adverse effects). Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study. | Baseline up to a mean duration of 54 months |
| Number of Participants for Physicians' Assessment of Handling of ReFacto | Subjective assessment by the physician to evaluate the participants' handling (preparation and administration) of ReFacto. Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study. | Baseline up to a mean duration of 54 months |
| Number of Participants for Patients' Assessment of Handling of ReFacto | Subjective assessment by the participant on handling (preparation and administration) of ReFacto. Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study. | Baseline up to a mean duration of 54 months |
| Number of Participants for Days of Sick Leave Per Month | Days of sick leave (missing work or school) per month categorized as No days of absence, Number of days of absence, Long-term inability to work or study, Not employed or at school, or No specification. | Baseline up to a mean duration of 54 months |
| Berlin |
| Germany |
| 10249 |
| Germany |
| Pfizer Investigational Site | Wiesbaden | Germany | 65191 | Germany |
| Pfizer Investigational Site | Frankfurt am Main | Hesse | 60596 | Germany |
| Pfizer Investigational Site | Giessen | Hesse | 35385 | Germany |
| Pfizer Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| Pfizer Investigational Site | Rostock | Mecklenburg-Vorpommern | 18055 | Germany |
| Pfizer Investigational Site | Bonn | North Rhine-Westphalia | 53105 | Germany |
| Pfizer Investigational Site | Halle | Saxony-Anhalt | 06120 | Germany |
| Pfizer Investigational Site | Stadtroda | Thuringia | 07646 | Germany |
| Pfizer Investigational Site | Berlin | 13353 | Germany |
| Pfizer Investigational Site | Bermen | 28205 | Germany |
| Pfizer Investigational Site | Erlangen | 91054 | Germany |
| Pfizer Investigational Site | Frankfurt A. M. | 60594 | Germany |
| Pfizer Investigational Site | Hamburg | 20246 | Germany |
| Pfizer Investigational Site | Heidelberg | 69123 | Germany |
| Pfizer Investigational Site | Homburg | 66424 | Germany |
| Pfizer Investigational Site | Klipphausen | 01665 | Germany |
| Pfizer Investigational Site | Leipzig | 04103 | Germany |
| Pfizer Investigational Site | Lübeck | 23538 | Germany |
| Pfizer Investigational Site | München | 80336 | Germany |
| Pfizer Investigational Site | München | 80337 | Germany |
| Pfizer Investigational Site | Münster | D-48143 | Germany |
| Pfizer Investigational Site | Potsdam | 14467 | Germany |
| Pfizer Investigational Site | Schwerin | 19049 | Germany |
| Pfizer Investigational Site | Ulm | 89081 | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ReFacto (Moroctocog Alfa) | B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Mean Number of Bleeding Episodes Per Patient Year | Participants with hemophilia A suffer from a hereditary lack of blood clotting factor VIII. As a consequence, the ability of the blood to coagulate is reduced and bleedings at any site or organ of the body may occur after minor injury or even spontaneously. Predominantly, joints, muscles, and internal organs are affected by bleeding complications. Participants reported the occurrence of each bleeding episode while on study. The bleeding rate for each participant was calculated by number of reported episodes per years on study. | Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia. | Posted | Mean | Standard Deviation | episodes per year | Baseline up to a mean duration of 54 months |
|
|
| |||||||||||||||||||||||||
| Primary | Mean Number of Bleeding-related Exposure Days Per Patient Year | Exposure days are the number of days of treatment with ReFacto. | Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia. | Posted | Mean | Standard Deviation | days per year | Baseline up to a mean duration of 54 months |
|
| ||||||||||||||||||||||||||
| Primary | Mean Number of Exposure Days Per Patient Year | Exposure days are the number of days of treatment with ReFacto. | Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia. | Posted | Mean | Standard Deviation | days per year | Baseline up to a mean duration of 54 months |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs are any undesired side effect which occurred in a participant undergoing study treatment independent of whether a correlation with study treatment was suspected or not. SAEs are undesired events which were lethal or life-threatening, made hospitalization or extension of hospital stay necessary, lead to permanent damage with handicap (inability to work), as well as congenital anomalies, malignant disease, or overdosing. Also presence of inhibitors, thrombotic events, erythrocyte agglutination, allergic reactions, less than therapeutic effect, and inhibitor development were considered SAEs. | Safety population includes all subjects with a baseline visit; (n)=number of participants with events. | Posted | Number | events | Baseline up to a mean duration of 54 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With de Novo Inhibitor Formation | The applied criteria of clinical relevance for de novo inhibitor formation was defined as normal Factor VIII dosage was ineffective to control a bleeding, control of bleeding episodes required increasing Factor VIII dosage, change of concentrate type (administration of activated Prothrombin-Complex Concentrate [aPCC] or recombinant Factor VII [rFVII ]) was needed to stop a bleeding, or change of therapy strategy (intensive prophylaxis or Immune Tolerance Induction [ITI]) was required. | Safety population includes all subjects with a baseline visit. | Posted | Number | participants | Baseline up to a mean duration of 54 months |
|
| |||||||||||||||||||||||||||
| Secondary | Mean Annual ReFacto Consumption Per Patient Year | ReFacto administered as International Units (IU) according to the physician's decision following the drug's summary of product characteristics (SPC) and according to usual care principles. | Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia. | Posted | Mean | Standard Deviation | International units per year | Baseline up to a mean duration of 54 months |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants for Physicians' Assessment of Satisfaction With Treatment Success | Subjective assessment by the physician to evaluate treatment success (i.e., control of bleeding, Factor VIII consumption, treatment efficacy and tolerance, handling of preparation, and days missing from work or school). Physician rated assessment could be categorized as Very satisfied, Satisfied, Unsatisfied, or Very unsatisfied; no criteria was pre-specified for the assessment categories in this observational study. | Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available. | Posted | Number | participants | Baseline up to a mean duration of 54 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants for Physicians' Assessment of Efficacy | Subjective assessment by the physician to evaluate control of bleeding. Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study. | Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available. | Posted | Number | participants | Baseline up to a mean duration of 54 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants for Patients' Assessment of Efficacy | Subjective assessment by the participant to evaluate control of bleeding. Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study. | Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available. | Posted | Number | participants | Baseline up to a mean duration of 54 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants for Physicians' Assessment of Tolerance | Subjective assessment by the physician to evaluate the participants' tolerance of treatment with ReFacto (i.e., dose, administration method, or adverse effects). Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study. | Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available. | Posted | Number | participants | Baseline up to a mean duration of 54 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants for Patients' Assessment of Tolerance | Subjective assessment by the participant to evaluate tolerance of treatment with ReFacto (i.e., dose, administration method, or adverse effects). Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study. | Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available. | Posted | Number | participants | Baseline up to a mean duration of 54 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants for Physicians' Assessment of Handling of ReFacto | Subjective assessment by the physician to evaluate the participants' handling (preparation and administration) of ReFacto. Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study. | Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available. | Posted | Number | participants | Baseline up to a mean duration of 54 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants for Patients' Assessment of Handling of ReFacto | Subjective assessment by the participant on handling (preparation and administration) of ReFacto. Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study. | Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available. | Posted | Number | participants | Baseline up to a mean duration of 54 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants for Days of Sick Leave Per Month | Days of sick leave (missing work or school) per month categorized as No days of absence, Number of days of absence, Long-term inability to work or study, Not employed or at school, or No specification. | Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available. | Posted | Number | participants | Baseline up to a mean duration of 54 months |
|
|
Baseline up to a mean duration of 54 months
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ReFacto (Moroctocog Alfa) | B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings. | 141 | 288 | 118 | 288 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemolysis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Conductive deafness | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Middle ear effusion | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal infarction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Lip haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Chills | General disorders | MedDRA | Systematic Assessment |
| |
| Concomitant disease progression | General disorders | MedDRA | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA | Systematic Assessment |
| |
| Death | General disorders | MedDRA | Systematic Assessment |
| |
| Developmental delay | General disorders | MedDRA | Systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Thrombosis in device | General disorders | MedDRA | Systematic Assessment |
| |
| Unevaluable event | General disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Gallbladder polyp | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Acquired immunodeficiency syndrome | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Anogenital warts | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cerebral toxoplasmosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Implant site infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hepatic rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Anti factor VIII antibody positive | Investigations | MedDRA | Systematic Assessment |
| |
| Anti factor VIII antibody test | Investigations | MedDRA | Systematic Assessment |
| |
| Antiphospholipid antibodies | Investigations | MedDRA | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Biopsy testes | Investigations | MedDRA | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA | Systematic Assessment |
| |
| Catheterisation cardiac | Investigations | MedDRA | Systematic Assessment |
| |
| Coagulation factor VIII level decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Coagulation factor inhibitor assay | Investigations | MedDRA | Systematic Assessment |
| |
| Drug specific antibody present | Investigations | MedDRA | Systematic Assessment |
| |
| Free haemoglobin present | Investigations | MedDRA | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Investigation | Investigations | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Haemophilic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Central nervous system lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cubital tunnel syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dyspraxia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Antisocial behaviour | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Enuresis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal haemorrhage | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Testicular haemorrhage | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Adenotonsillectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Arthrodesis | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Bone operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Central venous catheter removal | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Dental care | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Ear tube insertion | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Joint arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Joint surgery | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Ossiculoplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Skin neoplasm excision | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Surgery | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Thyroidectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Vascular operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Wisdom teeth removal | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Vein disorder | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Spontaneous haematoma | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Cheilosis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Lip haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Tooth loss | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Tooth socket haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Unevaluable event | General disorders | MedDRA | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Acquired immunodeficiency syndrome | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| HIV infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis media viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Accident at work | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Electric shock | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Genital injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Limb crushing injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Mouth injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Open wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Arthroscopy | Investigations | MedDRA | Systematic Assessment |
| |
| Biopsy stomach | Investigations | MedDRA | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA | Systematic Assessment |
| |
| Coagulation factor VIII level decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Endoscopy upper gastrointestinal tract | Investigations | MedDRA | Systematic Assessment |
| |
| Free haemoglobin present | Investigations | MedDRA | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Haemophilic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Lordosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Soft tissue haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Facial nerve disorder | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Tongue biting | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Affect lability | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Apathy | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Violence-related symptom | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal haemorrhage | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Breast haematoma | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Tonsillar inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin chapped | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Subcutaneous nodule | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Adenotonsillectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Bursa removal | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Catheterisation venous | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Central venous catheter removal | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Central venous catheterisation | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Dental care | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Joint injection | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Medical device implantation | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Medical device removal | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Penile operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Plastic surgery | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Radiotherapy to joint | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Suture insertion | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Suture removal | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Synovectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Tonsillectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Wisdom teeth removal | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Lymphostasis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Unevaluable event | General disorders | MedDRA | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C427184 | recombinant factor VIII SQ |
Not provided
Not provided
Not provided
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