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| ID | Type | Description | Link |
|---|---|---|---|
| B1821011 | 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 BeneFix® in usual health care settings in Germany.
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 B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BeneFIX | Drug | Patients will be treated in accordance with the requirements of the labeling of BeneFIX 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 |
|---|---|---|
| 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 8.7 years) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious. | Baseline until last visit (up to 8.7 years) |
| 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. Relatedness to BeneFIX was assessed by the investigator. | Baseline until last visit (up to 8.7 years) |
| Number of Participants With Factor IX (FIX) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay | FIX 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 8.7 years) |
| Number of Participants With Adverse Events (AEs) of Special Interest | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Adverse Events of special interest included allergic reactions, less than expected therapeutic effect (LETE) of drug, lack of efficacy/low recovery, erythrocyte agglutination in tube or syringe red blood cell (RBC) agglutination phenomena and thrombogenicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Total Number of Bleeding Episodes in Participants | Participants documented all bleeding episodes in a diary during the study. | Baseline until last visit (up to 8.7 years) |
| Mean Total Number of Bleeding Episodes Per Year in Participants |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Patients with hemophilia B
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allgemeines Krankenhaus Linz, Kinderklinik | Linz | 4020 | Austria | |||
| Sonnengesundheitszentrum |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | BeneFIX: On-Demand | Participants were treated with intravenous (IV) injection of BeneFIX 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 42.4 ± 16.6 international units per kilogram [IU/kg]). Participants were observed for up to a maximum duration of 8.7 years in this study. |
| FG001 | BeneFIX: Prophylaxis | Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years 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 Benefix.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BeneFIX: On Demand | Participants were treated with IV injection of BeneFIX 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 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years 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 8.7 years) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious. | Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. | Posted | Number | participants | Baseline until last visit (up to 8.7 years) |
|
Baseline until last visit (up to 8.7 years)
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.
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 | BeneFIX: On Demand | Participants were treated with IV injection of BeneFIX 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 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v19.0 | 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 |
|---|---|
| D002836 | Hemophilia B |
| 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 |
|---|---|
| D005164 | Factor IX |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline until last visit (up to 8.7 years) |
| Investigator Assessment of Treatment Tolerability of Participants | Investigator assessed the tolerability of participants and categorized as very good, good, moderate and poor. | End of study visit (any time up to 8.7 years) |
| Participant Assessment of Treatment Tolerability | Participants evaluated their treatment (BeneFIX) tolerability and rated it in 4 categories as very good, good, moderate and poor. | End of study visit (any time up to 8.7 years) |
Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated by mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation.
| Baseline until last visit (up to 8.7 years) |
| Number of Participants With Change From Baseline Status in Number of 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 was 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, up to 8.7 years |
| Investigator Assessment of Treatment Efficacy of Participants | Investigator evaluated the efficacy of BeneFIX in participants and rated it in 4 categories as very good, good, moderate and poor. | End of study visit (any time up to 8.7 years) |
| Investigator Assessment of Treatment Handling of Participants | Investigator evaluated the handling (administration) of BeneFIX by participants and rated it in 4 categories as very good, good, moderate and poor. | End of study visit (any time up to 8.7 years) |
| Assessment of Treatment Efficacy by the Participants | Participants evaluated the efficacy of BeneFIX and rated it in 4 categories as very good, good, moderate and poor. | End of study visit (any time up to 8.7 years) |
| Assessment of Treatment Handling by the Participants | Participants evaluated the handling (administration) of BeneFIX and rated it in 4 categories as very good, good, moderate and poor. | End of study visit (any time up to 8.7 years) |
| Investigator Assessment of Treatment Satisfaction of Participants | Investigator evaluated the participant's satisfaction of treatment with BeneFIX and rated it in 4 categories as very satisfied, satisfied, unsatisfied and very unsatisfied. | Baseline up to 8.7 years |
| München |
| Bavaria |
| 80336 |
| Germany |
| Werlhof-Institut für Haemostaseologie GmbH | Hanover | Lower Saxony | 30159 | Germany |
| Institut für Thrombophilie und Hämostaseologie | Münster | North Rhine-Westphalia | 48143 | Germany |
| Vivantes Klinikum im Friedrichshain | Berlin | 10249 | Germany |
| Charite Campus Virchow-Klinikum, Padiatrie mit S. Hamatologie und Onkologie | Berlin | 13353 | Germany |
| Kinder- und Jugendarzt-Praxis Blaubeuren | Blaubeuren Abbey | 89143 | Germany |
| Institute of Experimental Haematology and Transfusion Medicine | Bonn | 53127 | Germany |
| Praxis fur Kinder- und Jugendmedizin, Homoopathie | Brannenburg | 83098 | Germany |
| Klinikum Bremen-Mitte gGmbH, Professor Hess Kinderklinik | Bremen | 28177 | Germany |
| Gemeinschaftspraxis fuer Haematologie und Onkologie | Cologne | 50677 | Germany |
| Klinikum Delmehorst gGmbH, Padiatrie | Delmenhorst | 27753 | Germany |
| CRC Coagulation Research Centre GmbH | Duisburg | 47051 | Germany |
| Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie | Düsseldorf | 40225 | Germany |
| Klinikum der Martin-Luther-Universitaet Halle-Wittenberg | Halle | 06120 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Universitaetsklinikum Eppendorf | Hamburg | 20251 | Germany |
| SRH Kurpfalzkrankenhaus Heidelberg | Heidelberg | 69123 | Germany |
| Klinikum Memmingen, Kinderklinik | Memmingen | 87700 | Germany |
| Universitaetskinderklinik und Poliklinik im Dr. von Haunerschen | München | 80337 | Germany |
| Universitaetsklinik fuer Kinder- und Jugendmedizin | Tübingen | 72076 | Germany |
| BG001 |
| BeneFIX: Prophylaxis |
Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants were treated with IV injection of BeneFIX 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 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study. |
| OG001 | BeneFIX: Prophylaxis | Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years 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. Relatedness to BeneFIX was assessed by the investigator. | Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. | Posted | Number | participants | Baseline until last visit (up to 8.7 years) |
|
|
|
| Primary | Number of Participants With Factor IX (FIX) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay | FIX 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 Benefix. | Posted | Number | participants | Baseline until last visit (up to 8.7 years) |
|
|
|
| Primary | Number of Participants With Adverse Events (AEs) of Special Interest | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Adverse Events of special interest included allergic reactions, less than expected therapeutic effect (LETE) of drug, lack of efficacy/low recovery, erythrocyte agglutination in tube or syringe red blood cell (RBC) agglutination phenomena and thrombogenicity. | Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. | Posted | Number | participants | Baseline until last visit (up to 8.7 years) |
|
|
|
| Primary | Investigator Assessment of Treatment Tolerability of Participants | Investigator assessed the tolerability of participants and categorized as very good, good, moderate and poor. | Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | End of study visit (any time up to 8.7 years) |
|
|
|
| Primary | Participant Assessment of Treatment Tolerability | Participants evaluated their treatment (BeneFIX) tolerability and rated it in 4 categories as very good, good, moderate and poor. | Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | End of study visit (any time up to 8.7 years) |
|
|
|
| Secondary | Mean Total Number of Bleeding Episodes in Participants | Participants documented all bleeding episodes in a diary during the study. | Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | bleeding episodes | Baseline until last visit (up to 8.7 years) |
|
|
|
| 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 by mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation. | Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | bleeding episodes per year | Baseline until last visit (up to 8.7 years) |
|
|
|
| Secondary | Number of Participants With Change From Baseline Status in Number of 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 was 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. | Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Baseline, up to 8.7 years |
|
|
|
| Secondary | Investigator Assessment of Treatment Efficacy of Participants | Investigator evaluated the efficacy of BeneFIX in participants and rated it in 4 categories as very good, good, moderate and poor. | Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | End of study visit (any time up to 8.7 years) |
|
|
|
| Secondary | Investigator Assessment of Treatment Handling of Participants | Investigator evaluated the handling (administration) of BeneFIX by participants and rated it in 4 categories as very good, good, moderate and poor. | Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | End of study visit (any time up to 8.7 years) |
|
|
|
| Secondary | Assessment of Treatment Efficacy by the Participants | Participants evaluated the efficacy of BeneFIX and rated it in 4 categories as very good, good, moderate and poor. | Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | End of study visit (any time up to 8.7 years) |
|
|
|
| Secondary | Assessment of Treatment Handling by the Participants | Participants evaluated the handling (administration) of BeneFIX and rated it in 4 categories as very good, good, moderate and poor. | Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | End of study visit (any time up to 8.7 years) |
|
|
|
| Secondary | Investigator Assessment of Treatment Satisfaction of Participants | Investigator evaluated the participant's satisfaction of treatment with BeneFIX and rated it in 4 categories as very satisfied, satisfied, unsatisfied and very unsatisfied. | Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Baseline up to 8.7 years |
|
|
|
| 8 |
| 25 |
| 18 |
| 25 |
| EG001 | BeneFIX: Prophylaxis | Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study. | 29 | 55 | 46 | 55 |
| Haemorrhagic diathesis | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Phimosis | Congenital, familial and genetic disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Middle ear disorder | Ear and labyrinth disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Dental cyst | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Portal hypertensive gastropathy | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Adverse event | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Complication associated with device | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Mass | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Necrosis | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Polyp | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Allergy to arthropod sting | Immune system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Blister infected | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Chronic tonsillitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Pilonidal cyst | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Muscle injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Sports injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Angiogram | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Inhibiting antibodies positive | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Extraskeletal ossification | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Haemophilic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Soft tissue haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Synovial disorder | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Haemangioma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Non-systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Device defective | Product Issues | MedDRA v19.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Tonsillar atrophy | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Arthrodesis | Surgical and medical procedures | MedDRA v19.0 | Non-systematic Assessment |
|
| Synovectomy | Surgical and medical procedures | MedDRA v19.0 | Non-systematic Assessment |
|
| Wisdom teeth removal | Surgical and medical procedures | MedDRA v19.0 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Middle ear effusion | Ear and labyrinth disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Secondary hypogonadism | Endocrine disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Loose tooth | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Tongue haemorrhage | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Tooth loss | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Tooth socket haemorrhage | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Adverse event | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Medical device discomfort | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Polyp | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Allergy to venom | Immune system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Micrococcus infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Superinfection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Tonsillitis bacterial | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
|
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Accident at work | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Bone contusion | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Bone fissure | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Foreign body | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Limb crushing injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Mouth injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Muscle contusion | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Muscle injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Nasal injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Penis injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Splinter | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Sports injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Tongue injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Aspiration joint | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| CD4 lymphocytes decreased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Laboratory test abnormal | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Oesophagoscopy | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Bone lesion | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Haemophilic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Myosclerosis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Pelvic deformity | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Soft tissue haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Non-systematic Assessment |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Non-systematic Assessment |
|
| Oral fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v19.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Piriformis syndrome | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Delivery | Pregnancy, puerperium and perinatal conditions | MedDRA v19.0 | Non-systematic Assessment | This adverse event was reported in the participant who was the husband of woman who gave birth. |
|
| Device issue | Product Issues | MedDRA v19.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Enuresis | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Generalised anxiety disorder | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Renal haemorrhage | Renal and urinary disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Breast haematoma | Reproductive system and breast disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Haemorrhage subepidermal | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Adenoidectomy | Surgical and medical procedures | MedDRA v19.0 | Non-systematic Assessment |
|
| Arthrodesis | Surgical and medical procedures | MedDRA v19.0 | Non-systematic Assessment |
|
| Artificial crown procedure | Surgical and medical procedures | MedDRA v19.0 | Non-systematic Assessment |
|
| Circumcision | Surgical and medical procedures | MedDRA v19.0 | Non-systematic Assessment |
|
| Dental care | Surgical and medical procedures | MedDRA v19.0 | Non-systematic Assessment |
|
| Ear tube insertion | Surgical and medical procedures | MedDRA v19.0 | Non-systematic Assessment |
|
| Endodontic procedure | Surgical and medical procedures | MedDRA v19.0 | Non-systematic Assessment |
|
| Eye operation | Surgical and medical procedures | MedDRA v19.0 | Non-systematic Assessment |
|
| Gingivectomy | Surgical and medical procedures | MedDRA v19.0 | Non-systematic Assessment |
|
| Nail operation | Surgical and medical procedures | MedDRA v19.0 | Non-systematic Assessment |
|
| Tonsillectomy | Surgical and medical procedures | MedDRA v19.0 | Non-systematic Assessment |
|
| Femoral artery aneurysm | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA v19.0 | 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 |
| D040181 | Genetic Diseases, X-Linked |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
| Moderate |
|
| Poor |
|
| Moderate |
|
| Poor |
|
| Worsened |
|
| Moderate |
|
| Poor |
|
| Moderate |
|
| Poor |
|
| Moderate |
|
| Poor |
|
| Moderate |
|
| Poor |
|
| Unsatisfied |
|
| Very unsatisfied |
|