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| ID | Type | Description | Link |
|---|---|---|---|
| 52375916.1.0000.5412 | Other Identifier | CAAE |
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| Name | Class |
|---|---|
| Cellavita Pesquisa CientÃfica Ltda | OTHER |
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Cellavita HD is a stem-cell therapy for Huntington's Disease. This is a prospective, phase II, single-center, randomized (2:2:1), triple-blind, placebo controlled study, with two test doses of Cellavita HD product.
This is a phase II dose-response study in which participants with HD will receive three intravenous injections of the investigational product or placebo (one every month for three months) a total of three cycles. The subjects will be randomized in 2: 2: 1 ratio for the groups G1: lower dose (1x10^6 cells/weight range), G2: higher dose (2x10^6 cells/weight range) or G3: placebo. To identify the dose of the product that will provide the best clinical response, motor assessment will be performed with UHDRS scale and improvement will be evaluated by correlating before and after treatment scores. Additionally, also will be performed the combined score through the cUHDRS. Secondary evidences of efficacy will be evaluated through the data of functional state, total functional capacity, functional independence, psychiatric symptoms and cognition from UHDRS scale. Additionally, related data to clinical worsening, change of Body Mass Index (BMI), risk of suicide attempt and neurological image improvement will be evaluated. Safety evaluation will included the incidence and classification of the adverse events experienced by the subjects during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cellavita HD Lower Dose | Experimental | The participants randomized to this group will receive a total of 9 intravenous administrations of 1x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles). |
|
| Cellavita HD Higher Dose | Experimental | The participants randomized to this group will receive a total of 9 intravenous administrations of 2x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles). |
|
| Placebo Group | Placebo Comparator | The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cellavita HD lower dose | Biological | The participants will receive a total of 9 intravenous administrations of 1x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles). |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy by UHDRS-TMS | The primary endpoint was the rate of change (slope) in Unified Huntington's Disease Rating Scale - Total Motor Score from V0 to V11 (minimum 0, the best; and maximum 124, the worst). For each participant, a regression line was fitted (Y = a + bx), where b represents the individual slope, reflecting the annualised rate of motor progression. A negative slope suggests improvement or slower decline; a positive slope indicates worsening. To compare treatment efficacy, the slopes were analysed using a Mixed Model for Repeated Measures (MMRM), which accounts for intra-subject variability and missing data. This approach allowed estimation and comparison of average slopes between each treated group and placebo, providing a robust measure of motor function trajectory over time. | monthly for eleven months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy by UHDRS-TFC | Assessed by the rate of change (slope) from V0 to V11 in the UHDRS-TFC. The response of each participant or means of all participants was evaluated by the slopes of each regression line of UHDRS-TFC determined as follows: The equation describes the regression line: Y = a + bx, where:
|
| Measure | Description | Time Frame |
|---|---|---|
| Exposure to NestaCell (Former Cellavita HD) Product | Number of administrations of NestaCell (Former Cellavita HD) and Placebo | eleven months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joyce Macedo da Silva, MD | Azidus Brasil Scientific Research and Development Ltda | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azidus Brasil Pesquisa CientÃfica e Desenvolvimento Ltda. | Valinhos | São Paulo | 13271-130 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25097727 | Background | Aleynik A, Gernavage KM, Mourad YSh, Sherman LS, Liu K, Gubenko YA, Rameshwar P. Stem cell delivery of therapies for brain disorders. Clin Transl Med. 2014 Jul 19;3:24. doi: 10.1186/2001-1326-3-24. eCollection 2014. | |
| 21609310 | Background | de Almeida FM, Marques SA, Ramalho Bdos S, Rodrigues RF, Cadilhe DV, Furtado D, Kerkis I, Pereira LV, Rehen SK, Martinez AM. Human dental pulp cells: a new source of cell therapy in a mouse model of compressive spinal cord injury. J Neurotrauma. 2011 Sep;28(9):1939-49. doi: 10.1089/neu.2010.1317. Epub 2011 Aug 8. |
Not provided
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It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data will become public.
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Of 49 enrolled participants, 35 met the inclusion criteria and were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nestacell (Former Cellavita HD) Lower Dose | The participants randomized to this group will receive a total of 9 intravenous administrations of 1x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles). NestaCell lower dose: The participants will receive a total of 9 intravenous administrations of 1x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles). |
| FG001 | Nestacell (Former Cellavita HD) Higher Dose | The participants randomized to this group will receive a total of 9 intravenous administrations of 2 × 10^6 cells/weight range, divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles). NestaCell higher dose: The participants will receive a total of 9 intravenous administrations of 2x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles). |
| FG002 | Placebo Group | The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles). Placebo: The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Nestacell (Former Cellavita HD) Lower Dose | The participants randomized to this group will receive a total of 9 intravenous administrations of 1x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles). NestaCell lower dose: The participants will receive a total of 9 intravenous administrations of 1x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy by UHDRS-TMS | The primary endpoint was the rate of change (slope) in Unified Huntington's Disease Rating Scale - Total Motor Score from V0 to V11 (minimum 0, the best; and maximum 124, the worst). For each participant, a regression line was fitted (Y = a + bx), where b represents the individual slope, reflecting the annualised rate of motor progression. A negative slope suggests improvement or slower decline; a positive slope indicates worsening. To compare treatment efficacy, the slopes were analysed using a Mixed Model for Repeated Measures (MMRM), which accounts for intra-subject variability and missing data. This approach allowed estimation and comparison of average slopes between each treated group and placebo, providing a robust measure of motor function trajectory over time. | Posted | Mean | Standard Error | score on a scale/year | monthly for eleven months |
|
11 months
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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 | Nestacell (Former Cellavita HD) Lower Dose | The participants randomized to this group will receive a total of 9 intravenous administrations of 1x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles). NestaCell lower dose: The participants will receive a total of 9 intravenous administrations of 1x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalized for sinusitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristiane Valverde Wenceslau | Cellavita | +55 (19) 3829.0849 | cristiane.valverde@cellavitabrasil.com.br |
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 | Feb 23, 2021 | Sep 1, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2022 | Jun 30, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
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| ID | Term |
|---|---|
| D064987 | Cell- and Tissue-Based Therapy |
| D002452 | Cell Count |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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The study drugs will be provided in identical packages to maintain the study masking. Neither the Investigator nor the study team will know which drug the subject is receiving. In addition, the external outcome evaluator will receive the results in a codified manner (concealed).
|
| Cellavita HD higher dose | Biological | The participants will receive a total of 9 intravenous administrations of 2x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles). |
|
|
| Placebo | Other | The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles). |
|
|
| monthly for eleven months |
| 23345280 | Background | Barker RA, Mason SL, Harrower TP, Swain RA, Ho AK, Sahakian BJ, Mathur R, Elneil S, Thornton S, Hurrelbrink C, Armstrong RJ, Tyers P, Smith E, Carpenter A, Piccini P, Tai YF, Brooks DJ, Pavese N, Watts C, Pickard JD, Rosser AE, Dunnett SB; NEST-UK collaboration. The long-term safety and efficacy of bilateral transplantation of human fetal striatal tissue in patients with mild to moderate Huntington's disease. J Neurol Neurosurg Psychiatry. 2013 Jun;84(6):657-65. doi: 10.1136/jnnp-2012-302441. Epub 2013 Jan 23. |
| 16842168 | Background | Bonelli RM, Wenning GK. Pharmacological management of Huntington's disease: an evidence-based review. Curr Pharm Des. 2006;12(21):2701-20. doi: 10.2174/138161206777698693. |
| 24130093 | Background | de Souza PV, Alves FB, Costa Ayub CL, de Miranda Soares MA, Gomes JR. Human immature dental pulp stem cells (hIDPSCs), their application to cell therapy and bioengineering: an analysis by systematic revision of the last decade of literature. Anat Rec (Hoboken). 2013 Dec;296(12):1923-8. doi: 10.1002/ar.22808. Epub 2013 Oct 15. |
| 26237705 | Background | Fink KD, Deng P, Torrest A, Stewart H, Pollock K, Gruenloh W, Annett G, Tempkin T, Wheelock V, Nolta JA. Developing stem cell therapies for juvenile and adult-onset Huntington's disease. Regen Med. 2015;10(5):623-46. doi: 10.2217/rme.15.25. |
| 22032258 | Background | Kerkis I, Caplan AI. Stem cells in dental pulp of deciduous teeth. Tissue Eng Part B Rev. 2012 Apr;18(2):129-38. doi: 10.1089/ten.TEB.2011.0327. Epub 2011 Dec 28. |
| 24614516 | Background | Ross CA, Aylward EH, Wild EJ, Langbehn DR, Long JD, Warner JH, Scahill RI, Leavitt BR, Stout JC, Paulsen JS, Reilmann R, Unschuld PG, Wexler A, Margolis RL, Tabrizi SJ. Huntington disease: natural history, biomarkers and prospects for therapeutics. Nat Rev Neurol. 2014 Apr;10(4):204-16. doi: 10.1038/nrneurol.2014.24. Epub 2014 Mar 11. |
| 22967354 | Background | Kaplan A, Stockwell BR. Therapeutic approaches to preventing cell death in Huntington disease. Prog Neurobiol. 2012 Dec;99(3):262-80. doi: 10.1016/j.pneurobio.2012.08.004. Epub 2012 Aug 28. |
| 22996692 | Background | Weiss A, Trager U, Wild EJ, Grueninger S, Farmer R, Landles C, Scahill RI, Lahiri N, Haider S, Macdonald D, Frost C, Bates GP, Bilbe G, Kuhn R, Andre R, Tabrizi SJ. Mutant huntingtin fragmentation in immune cells tracks Huntington's disease progression. J Clin Invest. 2012 Oct;122(10):3731-6. doi: 10.1172/JCI64565. Epub 2012 Sep 17. |
| 15025718 | Background | Langbehn DR, Brinkman RR, Falush D, Paulsen JS, Hayden MR; International Huntington's Disease Collaborative Group. A new model for prediction of the age of onset and penetrance for Huntington's disease based on CAG length. Clin Genet. 2004 Apr;65(4):267-77. doi: 10.1111/j.1399-0004.2004.00241.x. |
| 40770775 | Derived | Fernandes JMS, Pagani E, Wenceslau CV, Ynoue LH, Ferrara L, Kerkis I. Phase II trial of intravenous human dental pulp stem cell therapy for Huntington's disease: a randomized, double-blind, placebo-controlled study. Stem Cell Res Ther. 2025 Aug 6;16(1):432. doi: 10.1186/s13287-025-04557-2. |
| 35626701 | Derived | Wenceslau CV, de Souza DM, Mambelli-Lisboa NC, Ynoue LH, Araldi RP, da Silva JM, Pagani E, Haddad MS, Kerkis I. Restoration of BDNF, DARPP32, and D2R Expression Following Intravenous Infusion of Human Immature Dental Pulp Stem Cells in Huntington's Disease 3-NP Rat Model. Cells. 2022 May 17;11(10):1664. doi: 10.3390/cells11101664. |
| Met discontinuation criteria |
|
| BG001 | Nestacell (Former Cellavita HD) Higher Dose | The participants randomized to this group will receive a total of 9 intravenous administrations of 2 × 10^6 cells/weight range, divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles). NestaCell higher dose: The participants will receive a total of 9 intravenous administrations of 2x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles). |
| BG002 | Placebo Group | The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles). Placebo: The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | meters |
|
| Weight | Mean | Standard Deviation | Kg |
|
| BMI | Mean | Standard Deviation | Kg/m^2 |
|
| CAG repeat | Count of Participants | Participants |
|
| CAP scale | The CAP scale (CAG-Age Product) measures cumulative disease burden in Huntington's disease by multiplying age by the difference between CAG repeat length and 35.5. Scores range from 0 to over 100, with higher values indicating greater genetic exposure, higher risk, and closer proximity to symptom onset (CAP=100 approximates average motor diagnosis age). It is a single composite score (units on a scale); lower scores indicate better outcomes, higher scores worse. | Mean | Standard Deviation | units on a scale |
|
| Years of symptoms | Mean | Standard Deviation | years |
|
| UHDRS Total Motor Score | The Unified Huntington's Disease Rating Scale Total Motor Score (UHDRS-TMS) is a clinician-rated scale assessing motor symptoms in Huntington's disease. It comprises 31 items grouped in 15 domains, such as chorea, dystonia, rigidity, oculomotor function, balance, and others. Scores range from 0 (normal motor function) to 124 (worst impairment). Higher scores indicate worse motor function and more severe disease progression. The total motor score is computed by summing the item scores on a 0-4 severity scale, resulting in a composite summed score measured in units on a scale. | Mean | Standard Deviation | units on a scale |
|
| UHDRS Total Functional Capacity | The Unified Huntington's Disease Rating Scale Total Functional Capacity (UHDRS-TFC) assesses a person's ability to manage work, finances, daily living, domestic chores, and care needs in Huntington's disease. It is a sum score of 5 items, with a range from 0 to 13, where higher scores indicate better functional capacity and lower scores reflect worse functioning or greater disability. The total score is computed by summing points from each item, measured in units on a scale. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Nestacell (Former Cellavita HD) Higher Dose | The participants randomized to this group will receive a total of 9 intravenous administrations of 2 × 10^6 cells/weight range, divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles). NestaCell higher dose: The participants will receive a total of 9 intravenous administrations of 2x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles). |
| OG002 | Placebo Group | The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles). Placebo: The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles). |
|
|
| Secondary | Efficacy by UHDRS-TFC | Assessed by the rate of change (slope) from V0 to V11 in the UHDRS-TFC. The response of each participant or means of all participants was evaluated by the slopes of each regression line of UHDRS-TFC determined as follows: The equation describes the regression line: Y = a + bx, where:
| Posted | Mean | Standard Error | score on a scale/year | monthly for eleven months |
|
|
|
| Other Pre-specified | Exposure to NestaCell (Former Cellavita HD) Product | Number of administrations of NestaCell (Former Cellavita HD) and Placebo | Posted | Mean | Standard Deviation | number os adminstrations | eleven months |
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| 12 |
| 14 |
| EG001 | Nestacell (Former Cellavita HD) Higher Dose | The participants randomized to this group will receive a total of 9 intravenous administrations of 2 × 10^6 cells/weight range, divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles). NestaCell higher dose: The participants will receive a total of 9 intravenous administrations of 2x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles). | 0 | 14 | 0 | 14 | 12 | 14 |
| EG002 | Placebo Group | The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles). Placebo: The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles). | 0 | 7 | 0 | 7 | 7 | 7 |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abnormal hair growth | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Wound | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Subcutaneous hemorrhage | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Change in hair color | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Atopic dermatitis | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyslipidemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Overweight | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cervicogenic gourd pain | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Essential tremor | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vertigo | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Normochromic and normocytic anemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pain in extremities | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vomit | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Phlebitis at the administration site | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Compulsion | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Obsessive-compulsive disorder | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypomania | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Altered mood | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Influenza | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Viral conjunctivitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Dengue Fever | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Increased blood creatinine | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Weight gain | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Positive salmonella test | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Abnormal temperature perception test | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Limb fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Subdural hematoma | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 24.1 | Systematic Assessment |
|
| Tooth implant | Surgical and medical procedures | MedDRA 24.1 | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA 24.1 | Systematic Assessment |
|
Not provided
Not provided
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |