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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017346-32 | EudraCT Number |
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| Name | Class |
|---|---|
| Ospedale San Raffaele | OTHER |
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This is phase I/II protocol to evaluate the safety and efficacy of WAS gene transfer into hematopoietic stem/progenitor cells for the treatment of Wiskott Aldrich Syndrome.
Wiskott-Aldrich Syndrome (WAS) is an X-linked primary immunodeficiency caused by mutations in the WAS gene which encodes the WAS protein (WASP), a cytoskeletal regulator which is expressed exclusively in hematopoietic cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TLT003 gene therapy | Experimental | Eligible subjects will receive intravenous (IV) infusion of TLT003 gene therapy. Subjects affected by WAS who don't have a suitable matched donor for allogenic hematopoietic stem cell transplantation will be included |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLT003 | Genetic | TLT003 is an autologous CD34+ cells collected from bone marrow and/or peripheral blood and transduced with a lentiviral vector encoding Wiskott-Aldrich syndrome (WAS) protein |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Reduced Conditioning Regimen | The absence of prolonged aplasia (defined as ANC <0.5×10^9/L [<500/μL] at Day +60, with no evidence of BM recovery and requiring backup administration) was assumed as demonstrating the safety of the RIC regimen. | Follow up phase - Median duration: 11.1 years (range: 8.01 -13.3 years) |
| Safety of Lentivirus Gene Transfer Into HSC | Safety and tolerability of lentiviral-transduced cell infusion. This will be evaluated on the basis of adverse events reporting and monitoring of the systemic reactions to cell infusion. | after 48 hours after Telethon003 infusion |
| Sustained Engraftment of Genetically Corrected Haematopoietic Stem Cells in Peripheral Blood and/or in Bone Marrow | Engraftment is characterized by the presence of gene modified cells in the BM or PB compartments. The main indicator of gene correction is detection of the WAS LVV sequences in the HSPCs and their progeny. The VCN, which is the mean number of integrated copies of the vector sequences per cell genome, was measured using PCR-based methods in DNA samples extracted from BM and PB cell populations at various timepoints post-treatment. Adequate engraftment was defined as either ≥0.04 VCN/cell in BM CD34+ cells or ≥0.01 VCN/cell in PB CD3+ cells. | at 1 year after Telethon003 infusion |
| Presence of Detectable Vector-derived WASP | The percentage of subjects who present the proportion of PB cells expressing WASP was assessed by flow cytometry analysis. | Median duration: 11.1 years (range: 8.01 -13.3 years) |
| Improved T-cell Functions | Improvement in in vitro T-cell proliferation was assessed upon stimulation with 3 doses of anti-immobilized CD3 (CD3i) monoclonal antibodies ≥1 year after Telethon003 infusion (as compared with pre-GT values) in PBMC and/or T-cell lines. The degree of correction was evaluated with respect to healthy controls. |
| Measure | Description | Time Frame |
|---|---|---|
| Lack of Immune Response to Transgene | Anti-WASP and anti-HIV-1 antibodies (anti-p24) were monitored to evaluate response to transgene and to vector, respectively. | up to 3 years after Telethon003 infusion |
| Reduced Frequency of Severe Infections |
Not provided
Inclusion Criteria:
Diagnosis of WAS defined by genetic mutation and at least one of the following criteria:
No HLA-identical sibling donor
Negative search for a matched unrelated donor (10/10) or an adequate unrelated cord blood donor (5-6/6) within 4-6 months
Parental/guardian/patient signed informed consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Raffaele - Telethon Institute for Gene Therapy (OSR-TIGET) | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23845947 | Background | Aiuti A, Biasco L, Scaramuzza S, Ferrua F, Cicalese MP, Baricordi C, Dionisio F, Calabria A, Giannelli S, Castiello MC, Bosticardo M, Evangelio C, Assanelli A, Casiraghi M, Di Nunzio S, Callegaro L, Benati C, Rizzardi P, Pellin D, Di Serio C, Schmidt M, Von Kalle C, Gardner J, Mehta N, Neduva V, Dow DJ, Galy A, Miniero R, Finocchi A, Metin A, Banerjee PP, Orange JS, Galimberti S, Valsecchi MG, Biffi A, Montini E, Villa A, Ciceri F, Roncarolo MG, Naldini L. Lentiviral hematopoietic stem cell gene therapy in patients with Wiskott-Aldrich syndrome. Science. 2013 Aug 23;341(6148):1233151. doi: 10.1126/science.1233151. Epub 2013 Jul 11. | |
| 19179314 |
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| ID | Title | Description |
|---|---|---|
| FG000 | OTL-103 Gene Therapy | Eligible subjects will receive intravenous (IV) infusion of OTL-103 gene therapy. Subjects affected by WAS who don't have a suitable matched donor for allogenic hematopoietic stem cell transplantation will be included OTL-103: OTL-103 is an autologous CD34+ cells collected from bone marrow and/or peripheral blood and transduced with a lentiviral vector encoding Wiskott-Aldrich syndrome (WAS) protein |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
paediatric population
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| ID | Title | Description |
|---|---|---|
| BG000 | OTL-103 Gene Therapy | Eligible subjects will receive intravenous (IV) infusion of OTL-103 gene therapy. Subjects affected by WAS who don't have a suitable matched donor for allogenic hematopoietic stem cell transplantation will be included OTL-103: OTL-103 is an autologous CD34+ cells collected from bone marrow and/or peripheral blood and transduced with a lentiviral vector encoding Wiskott-Aldrich syndrome (WAS) protein |
| 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 | Safety of Reduced Conditioning Regimen | The absence of prolonged aplasia (defined as ANC <0.5×10^9/L [<500/μL] at Day +60, with no evidence of BM recovery and requiring backup administration) was assumed as demonstrating the safety of the RIC regimen. | Mobilization Set (MS) for Safety analysis. Intent-to-treat (ITT) population for Efficacy analysis. All eight enrolled participants were included in the ITT and MS populations | Posted | Count of Participants | Participants | Follow up phase - Median duration: 11.1 years (range: 8.01 -13.3 years) |
|
Adverse events were reported in the statistical outputs from Screening onward. Post-treatment AEs were recorded during follow up - Median duration of follow-up was 11.1 (range: 8.0-13.3) years.
For each AE, the Investigator specified the date of onset, intensity, action taken, corrective therapy given, outcome, assessment regarding the causal relationship with the IMP. Adverse events were graded according to the CTCAE scale. Events meeting the Hy's law criteria ( [ALT] ≥3×upper limit of normal [ULN] and bilirubin ≥2×ULN [>35% direct bilirubin] or ALT ≥3×ULN and international normalized ratio >1.5, if international normalized ratio measured) were to be reported as SAEs.
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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 | OTL-103 Gene Therapy | Eligible subjects will receive intravenous (IV) infusion of OTL-103 gene therapy. Subjects affected by WAS who don't have a suitable matched donor for allogenic hematopoietic stem cell transplantation will be included OTL-103: OTL-103 is an autologous CD34+ cells collected from bone marrow and/or peripheral blood and transduced with a lentiviral vector encoding Wiskott-Aldrich syndrome (WAS) protein |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mesenteric lymphadenitis | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean Russell | Fondazione Telethon ETS | +39 02 2022 17210 | srussell@telethon.it |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 19, 2023 | Dec 16, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 21, 2023 | Dec 16, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D014923 | Wiskott-Aldrich Syndrome |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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This will be a single-arm study. All subjects will receive OTL-103 gene therapy and will be followed up for 15 years post gene therapy
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|
| Follow up phase - Median duration: 11.1 years (range: 8.01 -13.3 years) |
| Antigen-specific Responses to Vaccination | The ability to mount a protective humoral response to at least 4 out of 5 nominal antigens including antibodies to T-cell dependent antigens and conjugated or unconjugated polysaccharide antigens was measured after vaccination (planned >1 year after Telethon003 infusion). If results were available on n <5 antigens, the rule of at least n-1 applied to define success. | Follow up phase - Median duration: 11.1 years (range: 8.01 -13.3 years) |
| Improved Platelet Count and MPV Normalization | Sustained increase in platelet count compared to baseline, analyzing the individual longitudinal profile | up to 3 years after Telethon003 infusion |
| Overall Survival | Participant survival was monitored throughout the study. | Follow up phase - Median duration: 11.1 years (range: 8.01 -13.3 years) |
Decrease in number of severe infections as evaluated in the second and third year after the treatment by clinical history, complete physical examinations, hematological and microbiological tests.
| up to 3 years after Telethon003 infusion |
| Reduced Bruising and Bleeding Episodes | Reduction in bruising and/or bleeding manifestations when present, as assessed by clinical monitoring, compared to clinical history | 3 years |
| Reduced Autoimmunity Phenomena and Eczema | Reduction in laboratory markers (number and titer of antibody when available) and/or clinical manifestations of autoimmunity, as evaluated by organ-specific and systemic autoantibodies, imaging and clinical follow-up, compared to clinical history. Reduction in eczema as evaluated by clinical score | 3 years |
| Improved Quality of Life | Improved quality of life, measured after the first year of treatment by reduced hospitalization, reduced requirement of drugs, school attendance, social activities. | 3 year |
| Multilineage Engraftment of Genetically Corrected Cells | ≥0.04 VCN/cell on all the available peripheral blood and/or bone marrow cell subpopulations (BM subpopulations: GlyA+, CD15+, CD61+, CD3+, CD19+, CD56+; PB subpopulations: CD15+, CD19+, CD56+) | 3 years |
| Overall Safety of the Treatment | Recording of AE, AR, SAE/SAR, UAR, SUSAR | 8 years |
| Background |
| Aiuti A, Cattaneo F, Galimberti S, Benninghoff U, Cassani B, Callegaro L, Scaramuzza S, Andolfi G, Mirolo M, Brigida I, Tabucchi A, Carlucci F, Eibl M, Aker M, Slavin S, Al-Mousa H, Al Ghonaium A, Ferster A, Duppenthaler A, Notarangelo L, Wintergerst U, Buckley RH, Bregni M, Marktel S, Valsecchi MG, Rossi P, Ciceri F, Miniero R, Bordignon C, Roncarolo MG. Gene therapy for immunodeficiency due to adenosine deaminase deficiency. N Engl J Med. 2009 Jan 29;360(5):447-58. doi: 10.1056/NEJMoa0805817. |
| 20008254 | Background | Aiuti A, Roncarolo MG. Ten years of gene therapy for primary immune deficiencies. Hematology Am Soc Hematol Educ Program. 2009:682-9. doi: 10.1182/asheducation-2009.1.682. |
| 19351959 | Background | Bosticardo M, Marangoni F, Aiuti A, Villa A, Grazia Roncarolo M. Recent advances in understanding the pathophysiology of Wiskott-Aldrich syndrome. Blood. 2009 Jun 18;113(25):6288-95. doi: 10.1182/blood-2008-12-115253. Epub 2009 Apr 7. |
| 17078381 | Background | Boztug K, Dewey RA, Klein C. Development of hematopoietic stem cell gene therapy for Wiskott-Aldrich syndrome. Curr Opin Mol Ther. 2006 Oct;8(5):390-5. |
| 15308573 | Background | Burns S, Cory GO, Vainchenker W, Thrasher AJ. Mechanisms of WASp-mediated hematologic and immunologic disease. Blood. 2004 Dec 1;104(12):3454-62. doi: 10.1182/blood-2004-04-1678. Epub 2004 Aug 12. |
| 17051251 | Background | Charrier S, Dupre L, Scaramuzza S, Jeanson-Leh L, Blundell MP, Danos O, Cattaneo F, Aiuti A, Eckenberg R, Thrasher AJ, Roncarolo MG, Galy A. Lentiviral vectors targeting WASp expression to hematopoietic cells, efficiently transduce and correct cells from WAS patients. Gene Ther. 2007 Mar;14(5):415-28. doi: 10.1038/sj.gt.3302863. Epub 2006 Oct 19. |
| 15509508 | Background | Dupre L, Trifari S, Follenzi A, Marangoni F, Lain de Lera T, Bernad A, Martino S, Tsuchiya S, Bordignon C, Naldini L, Aiuti A, Roncarolo MG. Lentiviral vector-mediated gene transfer in T cells from Wiskott-Aldrich syndrome patients leads to functional correction. Mol Ther. 2004 Nov;10(5):903-15. doi: 10.1016/j.ymthe.2004.08.008. |
| 11812281 | Background | Follenzi A, Sabatino G, Lombardo A, Boccaccio C, Naldini L. Efficient gene delivery and targeted expression to hepatocytes in vivo by improved lentiviral vectors. Hum Gene Ther. 2002 Jan 20;13(2):243-60. doi: 10.1089/10430340252769770. |
| 18194074 | Background | Galy A, Roncarolo MG, Thrasher AJ. Development of lentiviral gene therapy for Wiskott Aldrich syndrome. Expert Opin Biol Ther. 2008 Feb;8(2):181-90. doi: 10.1517/14712598.8.2.181. |
| 19259069 | Background | Marangoni F, Bosticardo M, Charrier S, Draghici E, Locci M, Scaramuzza S, Panaroni C, Ponzoni M, Sanvito F, Doglioni C, Liabeuf M, Gjata B, Montus M, Siminovitch K, Aiuti A, Naldini L, Dupre L, Roncarolo MG, Galy A, Villa A. Evidence for long-term efficacy and safety of gene therapy for Wiskott-Aldrich syndrome in preclinical models. Mol Ther. 2009 Jun;17(6):1073-82. doi: 10.1038/mt.2009.31. Epub 2009 Mar 3. |
| 7795648 | Background | Villa A, Notarangelo L, Macchi P, Mantuano E, Cavagni G, Brugnoni D, Strina D, Patrosso MC, Ramenghi U, Sacco MG, et al. X-linked thrombocytopenia and Wiskott-Aldrich syndrome are allelic diseases with mutations in the WASP gene. Nat Genet. 1995 Apr;9(4):414-7. doi: 10.1038/ng0495-414. |
| 38446574 | Derived | Quaranta P, Basso-Ricci L, Jofra Hernandez R, Pacini G, Naldini MM, Barcella M, Seffin L, Pais G, Spinozzi G, Benedicenti F, Pietrasanta C, Cheong JG, Ronchi A, Pugni L, Dionisio F, Monti I, Giannelli S, Darin S, Fraschetta F, Barera G, Ferrua F, Calbi V, Ometti M, Di Micco R, Mosca F, Josefowicz SZ, Montini E, Calabria A, Bernardo ME, Cicalese MP, Gentner B, Merelli I, Aiuti A, Scala S. Circulating hematopoietic stem/progenitor cell subsets contribute to human hematopoietic homeostasis. Blood. 2024 May 9;143(19):1937-1952. doi: 10.1182/blood.2023022666. |
| 37244942 | Derived | Scala S, Ferrua F, Basso-Ricci L, Dionisio F, Omrani M, Quaranta P, Jofra Hernandez R, Del Core L, Benedicenti F, Monti I, Giannelli S, Fraschetta F, Darin S, Albertazzi E, Galimberti S, Montini E, Calabria A, Cicalese MP, Aiuti A. Hematopoietic reconstitution dynamics of mobilized- and bone marrow-derived human hematopoietic stem cells after gene therapy. Nat Commun. 2023 May 27;14(1):3068. doi: 10.1038/s41467-023-38448-y. |
| 30981783 | Derived | Ferrua F, Cicalese MP, Galimberti S, Giannelli S, Dionisio F, Barzaghi F, Migliavacca M, Bernardo ME, Calbi V, Assanelli AA, Facchini M, Fossati C, Albertazzi E, Scaramuzza S, Brigida I, Scala S, Basso-Ricci L, Pajno R, Casiraghi M, Canarutto D, Salerio FA, Albert MH, Bartoli A, Wolf HM, Fiori R, Silvani P, Gattillo S, Villa A, Biasco L, Dott C, Culme-Seymour EJ, van Rossem K, Atkinson G, Valsecchi MG, Roncarolo MG, Ciceri F, Naldini L, Aiuti A. Lentiviral haemopoietic stem/progenitor cell gene therapy for treatment of Wiskott-Aldrich syndrome: interim results of a non-randomised, open-label, phase 1/2 clinical study. Lancet Haematol. 2019 May;6(5):e239-e253. doi: 10.1016/S2352-3026(19)30021-3. Epub 2019 Apr 10. |
| Participants |
|
| 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 |
|
|
|
| Primary | Safety of Lentivirus Gene Transfer Into HSC | Safety and tolerability of lentiviral-transduced cell infusion. This will be evaluated on the basis of adverse events reporting and monitoring of the systemic reactions to cell infusion. | Posted | Count of Participants | Participants | after 48 hours after Telethon003 infusion |
|
|
|
| Primary | Sustained Engraftment of Genetically Corrected Haematopoietic Stem Cells in Peripheral Blood and/or in Bone Marrow | Engraftment is characterized by the presence of gene modified cells in the BM or PB compartments. The main indicator of gene correction is detection of the WAS LVV sequences in the HSPCs and their progeny. The VCN, which is the mean number of integrated copies of the vector sequences per cell genome, was measured using PCR-based methods in DNA samples extracted from BM and PB cell populations at various timepoints post-treatment. Adequate engraftment was defined as either ≥0.04 VCN/cell in BM CD34+ cells or ≥0.01 VCN/cell in PB CD3+ cells. | count of participants with sustained engraftment of genetically corrected HSPCs | Posted | Count of Participants | Participants | at 1 year after Telethon003 infusion |
|
|
|
| Primary | Presence of Detectable Vector-derived WASP | The percentage of subjects who present the proportion of PB cells expressing WASP was assessed by flow cytometry analysis. | Posted | Count of Participants | Participants | Median duration: 11.1 years (range: 8.01 -13.3 years) |
|
|
|
| Primary | Improved T-cell Functions | Improvement in in vitro T-cell proliferation was assessed upon stimulation with 3 doses of anti-immobilized CD3 (CD3i) monoclonal antibodies ≥1 year after Telethon003 infusion (as compared with pre-GT values) in PBMC and/or T-cell lines. The degree of correction was evaluated with respect to healthy controls. | Posted | Count of Participants | Participants | Follow up phase - Median duration: 11.1 years (range: 8.01 -13.3 years) |
|
|
|
| Primary | Antigen-specific Responses to Vaccination | The ability to mount a protective humoral response to at least 4 out of 5 nominal antigens including antibodies to T-cell dependent antigens and conjugated or unconjugated polysaccharide antigens was measured after vaccination (planned >1 year after Telethon003 infusion). If results were available on n <5 antigens, the rule of at least n-1 applied to define success. | Posted | Number | participants | Follow up phase - Median duration: 11.1 years (range: 8.01 -13.3 years) |
|
|
|
| Primary | Improved Platelet Count and MPV Normalization | Sustained increase in platelet count compared to baseline, analyzing the individual longitudinal profile | Posted | Count of Participants | Participants | up to 3 years after Telethon003 infusion |
|
|
|
| Primary | Overall Survival | Participant survival was monitored throughout the study. | Posted | Count of Participants | Participants | Follow up phase - Median duration: 11.1 years (range: 8.01 -13.3 years) |
|
|
|
| Secondary | Lack of Immune Response to Transgene | Anti-WASP and anti-HIV-1 antibodies (anti-p24) were monitored to evaluate response to transgene and to vector, respectively. | Posted | Count of Participants | Participants | up to 3 years after Telethon003 infusion |
|
|
|
| Secondary | Reduced Frequency of Severe Infections | Decrease in number of severe infections as evaluated in the second and third year after the treatment by clinical history, complete physical examinations, hematological and microbiological tests. | Not Posted | up to 3 years after Telethon003 infusion | Participants |
| Secondary | Reduced Bruising and Bleeding Episodes | Reduction in bruising and/or bleeding manifestations when present, as assessed by clinical monitoring, compared to clinical history | Not Posted | 3 years | Participants |
| Secondary | Reduced Autoimmunity Phenomena and Eczema | Reduction in laboratory markers (number and titer of antibody when available) and/or clinical manifestations of autoimmunity, as evaluated by organ-specific and systemic autoantibodies, imaging and clinical follow-up, compared to clinical history. Reduction in eczema as evaluated by clinical score | Not Posted | 3 years | Participants |
| Secondary | Improved Quality of Life | Improved quality of life, measured after the first year of treatment by reduced hospitalization, reduced requirement of drugs, school attendance, social activities. | Not Posted | 3 year | Participants |
| Secondary | Multilineage Engraftment of Genetically Corrected Cells | ≥0.04 VCN/cell on all the available peripheral blood and/or bone marrow cell subpopulations (BM subpopulations: GlyA+, CD15+, CD61+, CD3+, CD19+, CD56+; PB subpopulations: CD15+, CD19+, CD56+) | Not Posted | 3 years | Participants |
| Secondary | Overall Safety of the Treatment | Recording of AE, AR, SAE/SAR, UAR, SUSAR | Not Posted | 8 years | Participants |
| 0 |
| 8 |
| 8 |
| 8 |
| 8 |
| 8 |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pyrexia | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Food Allergy | Immune system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Device related infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pneumonia aspiration | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Appendicitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Aspergillus infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Bacterial sepsis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Cellulitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Device related sepsis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Influenza | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Otitis media | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Tooth Abscess | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Tracheitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Viral infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Irritability | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Polycythaemia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Phimosis | Congenital, familial and genetic disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Familial mediterranean fever | Congenital, familial and genetic disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Lymphatic malformation | Congenital, familial and genetic disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Retinal anomaly congenital | Congenital, familial and genetic disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Middle ear inflammation | Ear and labyrinth disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Graves' disease | Endocrine disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hypoaldosteronism | Endocrine disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hypothyroidism | Endocrine disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Precocious puberty | Endocrine disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Eye inflammation | Eye disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Blepharitis | Eye disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Dyschromatopsia | Eye disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Eczema eyelids | Eye disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Astigmatism | Eye disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Eyelid ptosis | Eye disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Keratitis | Eye disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Myopia | Eye disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Periorbital oedema | Eye disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Retinopathy | Eye disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Visual acuity reduced | Eye disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Dental caries | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Malocclusion | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Oral pain | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Tooth discolouration | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Gastric disorder | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Gingival disorder | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Ileal ulcer | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Large intestinal ulcer | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pyrexia | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Inflammation | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Catheter site haemorrhage | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Swelling face | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Vaccination site inflammation | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Catheter site erythema | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Catheter site inflammation | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Catheter site rash | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Adverse drug reaction | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Asthenia | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Catheter site mass | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Drug withdrawal syndrome | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Feeling abnormal | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Influenza like illness | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Non-cardiac chest pain | General disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Gallbladder disorder | Hepatobiliary disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Allergy to immunoglobulin therapy | Immune system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Food allergy | Immune system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hypersensitivity | Immune system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hypogammaglobulinaemia | Immune system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Rhinitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Otitis media | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Otitis media acute | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pharyngitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Conjunctivitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Ear infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Influenza | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Respiratory tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Sinusitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pneumonia | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Coronavirus infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Skin infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Tooth abscess | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Eye infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Amoebic dysentery | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Bacterial disease carrier | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Catheter site infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Folliculitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Oral candidiasis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Oral herpes | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Tracheitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Viral infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Abscess limb | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Bronchitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| COVID-19 | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Cytomegalovirus viraemia | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Epstein-Barr virus infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Paronychia | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Urethritis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Urinary tract infection bacterial | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Viral rhinits | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Amoebiasis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Bordetella infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Chronic tonisllitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Coxsackie vital infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Ear infection fungal | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Enterobiasis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Enterococcal sepsis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Enterocolitis viral | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Fungal skin infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Genital infection fungal | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Gingivitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Herpes virus infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Infection parasitic | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Laryngitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Laryngopharyngitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Lice infestation | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Measles | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Omphalitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Otitis externa | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pulpitis dental | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Varicella | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Torus fracture | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Eyelid injury | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Anti-platelet antibody positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Staphylococcus test positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hepatic enzyme increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Antineutrophil cytoplasmic antibody positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Streptococcus test positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Antinuclear antibody positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Blood immunoglonulin E increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Cytomegalovirus test positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Haemophilus test positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pseudomonas test positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Smooth muscle antibody positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Vitamin D decreased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Blood calcium decreased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Clostridium test positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Electrophoresis protein abnormal | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Intraocular pressure increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Adenovirus test positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Anti-saccharomyces cerevisiae antibody test positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| C-reactive protein increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Coombs direct test positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Epstein-Barr virus test positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Inflammatory marker increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Serum ferritin decreased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Serum ferritin increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Acinetobacter test positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Anti-thyroid antibody positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Anti-transglutaminase antibody increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Antimitochondrial antibody positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Antiribosomal P antibody positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Blood beta-D-glucan abnormal | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Blood bicarbonate decreased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Blood bilirubin increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Blood cholesterol increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Blood creatinine increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Blood culture positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Blood folate decreased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Blood glucose increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Blood iron decreased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Candida test positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Chest X-ray abnormal | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Dehydroepiandrosterone decreased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Double stranded DNA antibody positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Enterobacter test positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Faecal calprotectin increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Lymph nodes scan abnormal | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Moraxella test positive | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Occult blood | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Spirometry abnormal | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Transaminases increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Tri-iodothyronine increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Vitamin B12 increased | Investigations | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Insulin resistance | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Feeding intolerance | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Weight gain poor | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Short stature | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Headache | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Cerebral cyst | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Dyskinesia | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Speech disorder | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Aggression | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Anxiety | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Autism spectrum disorder | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Behaviour disorder | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Depression | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Drug dependece | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Enuresis | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Sleep disorder | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Haematuria | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Proteinuria | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pyelocaliectasis | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Nephrolothiasis | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Polyuria | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Renal impairment | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Balanoposthitis | Reproductive system and breast disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Acquired phimosis | Reproductive system and breast disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Penile erythema | Reproductive system and breast disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Perineal erythema | Reproductive system and breast disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Varicocele | Reproductive system and breast disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Nasal varices | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Reflux laryngitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Restrictive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pityriasis alba | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Perioral dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Vasculitis | Vascular disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Hypertension | Vascular disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
| Phlebitis | Vascular disorders | MedDRA version 26.0 | Systematic Assessment | Post-Treatment |
|
The Principal Investigator shall send any manuscript to the Sponsor/FT prior to its submission for publication. The Sponsor/FT shall have 45 days (silence=consent), from receipt of the manuscript, during which time any manuscript amendments may be suggested. The Principal Investigator shall accept the incorporation into the publication of any comments that do not affect the reliability of data, as well as the rights, safety and well-being of the patients.
| D008231 | Lymphopenia |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D007960 | Leukocyte Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
| D000081207 | Primary Immunodeficiency Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |