Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 10:44 PM
Ignite Modification Date: 2025-12-25 @ 8:14 PM
NCT ID: NCT03252535
Description: None
Frequency Threshold: 5
Time Frame: 11 months
Study: NCT03252535
Study Brief: Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
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). 0 None 1 14 12 14 View
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 None 0 14 12 14 View
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 None 0 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hospitalized for sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyslipidemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Overweight SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Cervicogenic gourd pain SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Essential tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Vertigo SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Normochromic and normocytic anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Pain in extremities SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Vomit SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Phlebitis at the administration site SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Compulsion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Anxiety disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Obsessive-compulsive disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Hypomania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Altered mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Influenza SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Viral conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Dengue Fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Increased blood creatinine SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Positive salmonella test SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Abnormal temperature perception test SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Subdural hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Face injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.1 View
Tooth implant SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Abnormal hair growth SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Wound SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Subcutaneous hemorrhage SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Change in hair color SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Atopic dermatitis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
Cataract operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.1 View