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Sponsor decision
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This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterize the safety and clinical activity of ATL001, autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with metastatic or recurrent melanoma.
This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterize the safety and clinical activity autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with metastatic or recurrent melanoma.
Patients will initially enter the study for procurement of tumour materials required to manufacture ATL001.Following manufacture of ATL001, the product will be given back to eligible patients following lymphodepletion.
Patients will be followed up for a period of 24 months post ATL001 infusion in the study.
Patients will continue to be followed up for a minimum of 5 years, as part of a separate Long Term Follow Up Protocol, or, if the separate protocol is not available at the study site, within this protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Following lymphodepletion, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2. |
|
| Cohort B | Experimental | Following lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL-2. |
|
| Cohort C | Experimental | Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATL001 | Biological | ATL001 infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Evaluate treatment-emergent adverse events (TEAEs) and serious AEs, per CTCAE, by incidence, severity and relationship to ATL001 | 60 months due to early termination |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Assessment for Change From Baseline in Tumour Size | Evaluate the clinical activity of ATL001 in patients with recurrent or metastatic melanoma using change from baseline in tumour size at week 6, week 12 and best overall change from baseline, as assessed by investigator and independent central review (ICR). | Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months |
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Inclusion Criteria:
Exclusion Criteria:
Additional Exclusion criteria will apply as per the study protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor, MD | Achilles Therapeutics UK Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Investigación Sanitaria Fundación Jimenez DÃaz | Madrid | 28040 | Spain | |||
| Centro Integral Oncologico Clara Campal (CIOCC) Hospital Universitario HM Sanchinarro |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A | Following lymphodepletion, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2. ATL001: ATL001 infusion |
| FG001 | Cohort B | Following lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL-2. ATL001: ATL001 infusion Checkpoint Inhibitor: Nivolumab |
| FG002 | Cohort C | Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2. ATL001: ATL001 infusion |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No differences.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A | Following lymphodepletion, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2. ATL001: ATL001 infusion |
| BG001 | Cohort B | Following lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL-2. ATL001: ATL001 infusion Checkpoint Inhibitor: Nivolumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE | Evaluate treatment-emergent adverse events (TEAEs) and serious AEs, per CTCAE, by incidence, severity and relationship to ATL001 | Posted | Count of Participants | Participants | 60 months due to early termination |
|
Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).
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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 | Cohort A | Following lymphodepletion, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2. ATL001: ATL001 infusion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 27.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA 27.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Matilde Saggese | Achilles Therapeutics UK Limited | 0786 9814607 | matildesaggese@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2023 | Jan 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Checkpoint Inhibitor |
| Drug |
Nivolumab |
|
| Disease Assessment for Overall Response Rate | Evaluate the endpoint of overall response rate (ORR), as assessed by investigator and ICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune modified RECIST( im-RECIST). RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) is a standardized system for measuring tumor response to treatment in clinical trials. Tumors are assessed by imaging (e.g., CT or MRI) based on changes in size. Responses are categorized as: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥30% reduction in the sum of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD). Progressive Disease (PD): ≥20% increase in the sum of target lesions, or appearance of new lesions. These criteria help assess the efficacy of treatments in solid tumors supported by im-RECIST in immunotherapy. | Every 6 weeks for 6 months, then every 3 months (up to 60 months due to early study termination) |
| Disease Assessment for Time to Response and Duration of Response | Evaluate the endpoints of time to response and duration of response (DOR) by the investigator and ICR, per RECIST v1.1 and im-RECIST. | Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months |
| Disease Assessment for Disease Control Rate | Evaluate the endpoints of disease control rate (DCR) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST. | Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months |
| Disease Assessment for Progression-Free Survival | Evaluate the efficacy endpoints of progression-free survival (PFS) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST. | Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months |
| Overall Survival | Evaluate overall survival (OS) by investigator | Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months |
| Madrid |
| 28050 |
| Spain |
| Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital | Cambridge | CB2 0QQ | United Kingdom |
| University College London Hospitals (UCLH) NHS Foundation Trust, University College Hospital | London | NW12PG | United Kingdom |
| Royal Free London NHS Foundation Trust, Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Guys and St Thomas' NHS Foundation Trust, Guy's Hospital | London | SE19RT | United Kingdom |
| The Royal Marsden NHS Foundation Trust, The Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| The Christie NHS Foundation Trust, Christie Hospital | Manchester | M20 4BX | United Kingdom |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| University Hospital Southampton NHS Foundation Trust, Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| study terminated by sponsor |
|
| BG002 | Cohort C | Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2. ATL001: ATL001 infusion |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Baseline ECOG performance status | The ECOG (Eastern Cooperative Oncology Group) performance score is a widely used scale to assess a patient's level of functioning, particularly in cancer clinical trials. This assessment was performed at the Baseline Screening period by the clinical research teams when they reviewed their patients. Score 0: Fully active, able to carry out all pre-disease performance without restrictions. Score 1: Restricted in physically strenuous activity but ambulatory and able to perform light work. | Count of Participants | Participants | No |
|
| OG002 | Cohort C | Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2. ATL001: ATL001 infusion |
|
|
| Secondary | Disease Assessment for Change From Baseline in Tumour Size | Evaluate the clinical activity of ATL001 in patients with recurrent or metastatic melanoma using change from baseline in tumour size at week 6, week 12 and best overall change from baseline, as assessed by investigator and independent central review (ICR). | Not Posted | Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months | Participants |
| Secondary | Disease Assessment for Overall Response Rate | Evaluate the endpoint of overall response rate (ORR), as assessed by investigator and ICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune modified RECIST( im-RECIST). RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) is a standardized system for measuring tumor response to treatment in clinical trials. Tumors are assessed by imaging (e.g., CT or MRI) based on changes in size. Responses are categorized as: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥30% reduction in the sum of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD). Progressive Disease (PD): ≥20% increase in the sum of target lesions, or appearance of new lesions. These criteria help assess the efficacy of treatments in solid tumors supported by im-RECIST in immunotherapy. | Posted | Count of Participants | Participants | Every 6 weeks for 6 months, then every 3 months (up to 60 months due to early study termination) |
|
|
|
| Secondary | Disease Assessment for Time to Response and Duration of Response | Evaluate the endpoints of time to response and duration of response (DOR) by the investigator and ICR, per RECIST v1.1 and im-RECIST. | Not Posted | Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months | Participants |
| Secondary | Disease Assessment for Disease Control Rate | Evaluate the endpoints of disease control rate (DCR) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST. | Not Posted | Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months | Participants |
| Secondary | Disease Assessment for Progression-Free Survival | Evaluate the efficacy endpoints of progression-free survival (PFS) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST. | Not Posted | Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months | Participants |
| Secondary | Overall Survival | Evaluate overall survival (OS) by investigator | Not Posted | Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months | Participants |
| 8 |
| 9 |
| 3 |
| 9 |
| 9 |
| 9 |
| EG001 | Cohort B | Following lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL-2. ATL001: ATL001 infusion Checkpoint Inhibitor: Nivolumab | 2 | 2 | 2 | 2 | 2 | 2 |
| EG002 | Cohort C | Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2. ATL001: ATL001 infusion | 1 | 2 | 1 | 2 | 2 | 2 |
| Abdominal wall infection | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Immune effector cell-associated neurotoxicity syndrome | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Klebsiella sepsis | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Drain site complication | Injury, poisoning and procedural complications | MedDRA 27.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Procedural pain | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Prothrombin time prolonged | Investigations | MedDRA 27.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Neutropenic sepsis | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Euthyroid sick syndrome | Endocrine disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Abdominal infection | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
|
| Malignant gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Inguinal mass | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Oesophageal spasm | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 27.0 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Brachiocephalic vein thrombosis | Vascular disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 27.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Axillary pain | General disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Procalcitonin increased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Intention tremor | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 27.0 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Gram stain positive | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Bacterial disease carrier | Infections and infestations | MedDRA 27.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Non-systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 27.0 | Non-systematic Assessment |
|
Range of other disclosure agreements across study sites. Following multi-center publication of the Study results made by Sponsor, the Institution and/or Principal Investigator may publish data or results from the Study provided the Sponsor is given 45 to 90 days to review and/or make comments and suggestions where pertinent.
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |