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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003880-38 | EudraCT Number |
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This study is being conducted by BioMarin Pharmaceutical Inc. as an open label, dose escalation study in order to determine the safety and efficacy of valoctocogene roxaparvovec (an Adenovirus-Associated Virus based gene therapy vector in participants with severe haemophilia A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| valoctocogene roxaparvovec | Experimental | Single administration of valoctocogene roxaparvovec at escalating doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valoctocogene roxaparvovec | Biological | Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | Adverse events (AEs) with onset or worsening after the investigational product were included. Participants with more than one AE of the same category were counted only once for that category. Serious adverse event (SAE) | Approximately up to 7 years after dosing |
| Number of Participant With Median FVIII Activity Levels >= 5 IU/dL Using Chromogenic Substrate Assay (CSA) | Responder/Non responder status, where a responder was defined as a participant with median FVIII activity of >= 5 IU/dL during Week 13-16 post-BMN 270 infusion | Week 13-16 post-BMN 270 infusion |
| Median FVIII Activity as Measured by Chromogenic Substrate Assay During Week 13-16 Post-BMN 270 Infusion | Values for FVIII activity were excluded from analysis if obtained within 72 hours since the last infusion of exogenous FVIII replacement therapy FVIII activity levels below the Lower limit of quantitation (LLOQ) will be imputed with 0 IU/dL Q1: 25% Percentile; Q3: 75% Percentile | Week 13-16 post-BMN 270 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Bleeding Rate Requiring Exogenous Factor VIII Replacement Treatment During Week 5 and Beyond | ABR= [Number of bleeding episodes during calculation period] / [Total number of days during the calculation period] ×365.25 A bleeding episode (treated) was defined as a bleed or symptoms associated with the development of a bleed (or multiple bleeds occurring in the same day) requiring FVIII replacement treatment within 72 hours of the start of the bleed. The baseline values for the secondary efficacy endpoints were based on the historical data prior to study enrollment. Annualized bleeding rate (ABR) |
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Inclusion Criteria:
Exclusion Criteria:
Biological males only
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | BioMarin Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital Birmingham | Birmingham | United Kingdom | ||||
| Addenbrooke's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40986187 | Derived | Santos S, Robinson TM, Trueman D. Estimated Long-Term Durability of Valoctocogene Roxaparvovec Treatment in Male patients with Severe Hemophilia A: An Extrapolation of Clinical Data. Adv Ther. 2025 Nov;42(11):5781-5793. doi: 10.1007/s12325-025-03368-4. Epub 2025 Sep 23. | |
| 38975624 | Derived | Symington E, Rangarajan S, Lester W, Madan B, Pierce GF, Raheja P, Millar C, Osmond D, Li M, Robinson TM. Valoctocogene roxaparvovec gene therapy provides durable haemostatic control for up to 7 years for haemophilia A. Haemophilia. 2024 Sep;30(5):1138-1147. doi: 10.1111/hae.15071. Epub 2024 Jul 8. |
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Total of 21 subjects were screened. Of those 21, 6 did not meet the eligibility criteria for enrollment in the study: 5 were found to be adeno-associated virus5 (AAV5) transduction inhibition (TI) or total antibody (TAb) positive, and 1 was assessed as being unable to comply with the requirements of the trial. Fifteen participants were enrolled in 270-201 and received BMN 270 in 1 of 4 dose cohorts
This study was conducted at 5 sites in United Kingdom (Basingstoke, Cambridge, Birmingham, Royal London, London, & Guy's and St. Thomas', London).
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| ID | Title | Description |
|---|---|---|
| FG000 | BMN 270 6E12 vg/kg | Cohort 1: 6E12 vector genomes (vg) per kilogram of body weight, given as a single intravenous dose (IV) valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A |
| FG001 | BMN 270 2E13 vg/kg | Cohort 2: 2E13 vg per kilogram, per kilogram of body weight, given as a single intravenous dose (IV) valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A |
| FG002 | BMN 270 4E13 vg/kg | Cohort 4: 4E13 vg per kilogram, per kilogram of body weight, given as a single intravenous dose (IV) valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A |
| FG003 | BMN 270 6E13 vg/kg | Cohort 3: 6E13 vg per kilogram, per kilogram of body weight, given as a single intravenous dose (IV) valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS): All enrolled participants who receive study drug and have at least one Baseline and post-Baseline assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | BMN 270 6E12 vg/kg | Cohort 1: 6E12 vector genomes (vg) per kilogram of body weight, given as a single intravenous dose (IV) valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A |
| BG001 | BMN 270 2E13 vg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at enrollment |
| 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 | Adverse events (AEs) with onset or worsening after the investigational product were included. Participants with more than one AE of the same category were counted only once for that category. Serious adverse event (SAE) | Safety analysis Population: The Safety analysis population was defined as all enrolled participants who received any amount of study drug. | Posted | Count of Participants | Participants | Approximately up to 7 years after dosing |
|
Approximately up to 7 years after dosing
AEs with onset or worsening after the investigational product were included
Subjects with more than one AE of the same PT were counted only once for that Preferred term (PT)
AEs were graded for severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version v4.03
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BMN 270 6E12 vg/kg | Cohort 1: 6E12 vector genomes (vg) per kilogram of body weight, given as a single intravenous dose (IV) valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemophilic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Konstantia-Maria Chavele, PhD, Director, Clinical Sciences | BioMarin (UK) Ltd | +44 207-4203351 | KonstantiaMaria.Chavele@bmrn.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 24, 2021 | Jan 29, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2019 | Jan 7, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D020141 | Hemostatic Disorders |
| D006402 | Hematologic Diseases |
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000723395 | Valoctocogene Roxaparvovec |
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|
| Week 5 and Beyond (Approximately 7 years post Infusion) |
| Annualized Factor VIII Utilization During Week 5 and Beyond | Annualized FVIII use (IU/kg/yr.) =[Sum of FVIII use (IU/kg) during calculation period] / [Total number of days during the calculation period] ×365.25 | Week 5 and Beyond (Approximately 7 years post Infusion) |
| Annualized Factor VIII Infusion Rate During Week 5 and Beyond | Annualized FVIII infusion rate (count/yr.) = [Number of FVIII replacement infusions during calculation period] / [Total number of days during the calculation period] ×365.25 | Week 5 and Beyond (Approximately 7 years post Infusion) |
| Cambridge |
| United Kingdom |
| St. Thomas' Hospital | London | United Kingdom |
| The Royal London Hospital | London | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | United Kingdom |
| 35879931 | Derived | Quinn J, Delaney KA, Wong WY, Miesbach W, Bullinger M. Psychometric Validation of the Haemo-QOL-A in Participants with Hemophilia A Treated with Gene Therapy. Patient Relat Outcome Meas. 2022 Jul 18;13:169-180. doi: 10.2147/PROM.S357555. eCollection 2022. |
| 35411075 | Derived | Fong S, Yates B, Sihn CR, Mattis AN, Mitchell N, Liu S, Russell CB, Kim B, Lawal A, Rangarajan S, Lester W, Bunting S, Pierce GF, Pasi KJ, Wong WY. Interindividual variability in transgene mRNA and protein production following adeno-associated virus gene therapy for hemophilia A. Nat Med. 2022 Apr;28(4):789-797. doi: 10.1038/s41591-022-01751-0. Epub 2022 Apr 11. |
| 34378280 | Derived | Pasi KJ, Laffan M, Rangarajan S, Robinson TM, Mitchell N, Lester W, Symington E, Madan B, Yang X, Kim B, Pierce GF, Wong WY. Persistence of haemostatic response following gene therapy with valoctocogene roxaparvovec in severe haemophilia A. Haemophilia. 2021 Nov;27(6):947-956. doi: 10.1111/hae.14391. Epub 2021 Aug 11. |
| 32915950 | Derived | Rosen S, Tiefenbacher S, Robinson M, Huang M, Srimani J, Mackenzie D, Christianson T, Pasi KJ, Rangarajan S, Symington E, Giermasz A, Pierce GF, Kim B, Zoog SJ, Vettermann C. Activity of transgene-produced B-domain-deleted factor VIII in human plasma following AAV5 gene therapy. Blood. 2020 Nov 26;136(22):2524-2534. doi: 10.1182/blood.2020005683. |
| 31893514 | Derived | Pasi KJ, Rangarajan S, Mitchell N, Lester W, Symington E, Madan B, Laffan M, Russell CB, Li M, Pierce GF, Wong WY. Multiyear Follow-up of AAV5-hFVIII-SQ Gene Therapy for Hemophilia A. N Engl J Med. 2020 Jan 2;382(1):29-40. doi: 10.1056/NEJMoa1908490. |
| 29224506 | Derived | Rangarajan S, Walsh L, Lester W, Perry D, Madan B, Laffan M, Yu H, Vettermann C, Pierce GF, Wong WY, Pasi KJ. AAV5-Factor VIII Gene Transfer in Severe Hemophilia A. N Engl J Med. 2017 Dec 28;377(26):2519-2530. doi: 10.1056/NEJMoa1708483. Epub 2017 Dec 9. |
Cohort 2: 2E13 vg per kilogram, given as a single intravenous dose (IV) valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A |
| BG002 | BMN 270 4E13 vg/kg | Cohort 4: 4E13 vg per kilogram, given as a single intravenous dose (IV) valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A |
| BG003 | BMN 270 6E13 vg/kg | Cohort 3: 6E13 vg per kilogram, given as a single intravenous dose (IV) valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A |
| BG004 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Baseline annualized FVIII usage | Mean | Standard Deviation | IU/kg/year |
|
| Baseline annualized number of FVIII infusions | Mean | Standard Deviation | infusions/year |
|
| Baseline ABR (treated bleeds) | Mean | Standard Deviation | bleeds/year |
|
| Baseline Bleed Counts (treated bleeds) | Count of Participants | Participants |
|
| History of previous diseases | Some subjects may have multiple conditions. In BMN 270-4E13 vg/kg Arm: 4 out of 6 subjects had no history of HepB/HepC/HIV/LD. One subject had multiple conditions (ie Hep B, Hep C and Liver Disease). In Total, 10 out of 15 subjects had no history of HepB/HepC/HIV/LD. | Count of Participants | Participants |
|
| Number of target joints | Count of Participants | Participants |
|
| BMN 270 2E13 vg/kg |
Cohort 2: 2E13 vg per kilogram, given as a single intravenous dose (IV) valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A |
| OG002 | BMN 270 4E13 vg/kg | Cohort 4: 4E13 vg per kilogram, given as a single intravenous dose (IV) valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A |
| OG003 | BMN 270 6E13 vg/kg | Cohort 3: 6E13 vg per kilogram, given as a single intravenous dose (IV) valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A |
|
|
| Primary | Number of Participant With Median FVIII Activity Levels >= 5 IU/dL Using Chromogenic Substrate Assay (CSA) | Responder/Non responder status, where a responder was defined as a participant with median FVIII activity of >= 5 IU/dL during Week 13-16 post-BMN 270 infusion | Full Analysis Set (FAS) population: defined as all enrolled participants who receive study drug and have at least one Baseline and post-Baseline assessment. | Posted | Count of Participants | Participants | Week 13-16 post-BMN 270 infusion |
|
|
|
| Primary | Median FVIII Activity as Measured by Chromogenic Substrate Assay During Week 13-16 Post-BMN 270 Infusion | Values for FVIII activity were excluded from analysis if obtained within 72 hours since the last infusion of exogenous FVIII replacement therapy FVIII activity levels below the Lower limit of quantitation (LLOQ) will be imputed with 0 IU/dL Q1: 25% Percentile; Q3: 75% Percentile | FAS Population | Posted | Median | Inter-Quartile Range | IU/dL | Week 13-16 post-BMN 270 infusion |
|
|
|
| Secondary | Annualized Bleeding Rate Requiring Exogenous Factor VIII Replacement Treatment During Week 5 and Beyond | ABR= [Number of bleeding episodes during calculation period] / [Total number of days during the calculation period] ×365.25 A bleeding episode (treated) was defined as a bleed or symptoms associated with the development of a bleed (or multiple bleeds occurring in the same day) requiring FVIII replacement treatment within 72 hours of the start of the bleed. The baseline values for the secondary efficacy endpoints were based on the historical data prior to study enrollment. Annualized bleeding rate (ABR) | FAS Population | Posted | Mean | Standard Deviation | bleeds/year | Week 5 and Beyond (Approximately 7 years post Infusion) |
|
|
|
| Secondary | Annualized Factor VIII Utilization During Week 5 and Beyond | Annualized FVIII use (IU/kg/yr.) =[Sum of FVIII use (IU/kg) during calculation period] / [Total number of days during the calculation period] ×365.25 | FAS Population | Posted | Mean | Standard Deviation | IU/kg/yr | Week 5 and Beyond (Approximately 7 years post Infusion) |
|
|
|
| Secondary | Annualized Factor VIII Infusion Rate During Week 5 and Beyond | Annualized FVIII infusion rate (count/yr.) = [Number of FVIII replacement infusions during calculation period] / [Total number of days during the calculation period] ×365.25 | FAS Population | Posted | Mean | Standard Deviation | Infusions/ year | Week 5 and Beyond (Approximately 7 years post Infusion) |
|
|
|
| 0 |
| 1 |
| 1 |
| 1 |
| 1 |
| 1 |
| EG001 | BMN 270 2E13 vg/kg | Cohort 2: 2E13 vg per kilogram, given as a single intravenous dose (IV) valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | BMN 270 4E13 vg/kg | Cohort 4: 4E13 vg per kilogram, given as a single intravenous dose (IV) valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A | 0 | 6 | 3 | 6 | 6 | 6 |
| EG003 | BMN 270 6E13 vg/kg | Cohort 3: 6E13 vg per kilogram, given as a single intravenous dose (IV) valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A | 0 | 7 | 5 | 7 | 7 | 7 |
| EG004 | Overall | Overall valoctocogene roxaparvovec: Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A | 0 | 15 | 9 | 15 | 15 | 15 |
| Acinic cell carcinoma of salivary gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Carotid artery dissection | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
|
| External ear inflammation | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cushingoid | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chorioretinopathy | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Scleral discolouration | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hangover | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Puncture site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vaccination site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Allergy to animal | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Epididymitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Epstein-Barr virus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pericoronitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Sputum purulent | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Viral pharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Coagulation factor VIII level decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Coagulation factor VIII level increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Thrombin time prolonged | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Polydipsia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Haemophilic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acinic cell carcinoma of salivary gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Haemangioma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Aura | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Carotid artery dissection | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Sleep deficit | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Typical aura without headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Epididymal cyst | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Sexual dysfunction | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Idiopathic guttate hypomelanosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Leukoderma | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Skin striae | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pregnancy of partner | Social circumstances | MedDRA 24.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
Not provided