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 @ 4:40 PM
Ignite Modification Date: 2025-12-25 @ 2:29 PM
NCT ID: NCT00227266
Description: None
Frequency Threshold: 0
Time Frame: Phase 1 Serious Adverse Events (time period during which placebo (1a) and treatment (1b)were randomly treated): 6 months. And Phase 1 and 2 Adverse Events: 12 months
Study: NCT00227266
Study Brief: Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1a Sitters Placebo Then Treatment Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form. None None 1 31 18 31 View
Cohort 1b Sitters Treatment Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form. None None 4 30 23 30 View
Cohort 2 Standers and Walkers - Treatment Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form. None None 4 33 28 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dehydration None Metabolism and nutrition disorders None View
Diarrhea None Gastrointestinal disorders None View
General Disorder None General disorders None View
Pneumonia None Respiratory, thoracic and mediastinal disorders None View
Tachyponea None Respiratory, thoracic and mediastinal disorders None View
Upper respiratory infection None Infections and infestations None View
Vomiting None Gastrointestinal disorders None View
Pneumonitis None Infections and infestations None View
Skin Rash None Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decreased Appetite None Metabolism and nutrition disorders None View
Dehydration None Metabolism and nutrition disorders None View
Dermatitis Allergic None Immune system disorders None View
Diarrhea None Gastrointestinal disorders None View
Dry Mouth None Gastrointestinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Ear Infection None Infections and infestations None View
Emotional Disorder of Childhood None Psychiatric disorders None View
Fatigue None General disorders None View
Femur Fracture None Musculoskeletal and connective tissue disorders None View
Foot Fracture None Musculoskeletal and connective tissue disorders None View
Forearm Fracture None Musculoskeletal and connective tissue disorders None View
Gastroesophagheal Reflux Disease None Gastrointestinal disorders None View
Hand Fracture None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View
Hypersensitivity None Immune system disorders None View
Impulsive Behaviour None Nervous system disorders None View
Incontinence None Renal and urinary disorders None View
Increased Appetite None Metabolism and nutrition disorders None View
Increased Urination Frequency None Renal and urinary disorders None View
Irritability None Nervous system disorders None View
Join Sprain None Injury, poisoning and procedural complications None View
Joint Pain None Musculoskeletal and connective tissue disorders None View
Lethargy None Nervous system disorders None View
Multiple Allergies None Immune system disorders None View
Muscle Cramp None Musculoskeletal and connective tissue disorders None View
Constipation None Gastrointestinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Croup None Infections and infestations None View
Vomiting None Gastrointestinal disorders None View
Weight Incresed None Investigations None View
Abdominal Pain Upper None Gastrointestinal disorders None View
Agitation None Nervous system disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Bronchitis None Infections and infestations None View
Chocking Sensation None Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion None Respiratory, thoracic and mediastinal disorders None View
Nasopharyngitis None Infections and infestations None View
Nausea None Gastrointestinal disorders None View
Otorrhoea None Ear and labyrinth disorders None View
Oxygen Saturation Decreased None Investigations None View
Pain in Extremity None Musculoskeletal and connective tissue disorders None View
Patella Fracture None Musculoskeletal and connective tissue disorders None View
Pharyngeal Pain None Respiratory, thoracic and mediastinal disorders None View
Pharyngeal Pain None Respiratory, thoracic and mediastinal disorders None View
Pneumonia None Respiratory, thoracic and mediastinal disorders None View
Pneumonitis None Infections and infestations None View
Pyrexia None General disorders None View
Rash Papular None Skin and subcutaneous tissue disorders None View
Rhinorrhoea None Respiratory, thoracic and mediastinal disorders None View
Sinusitis None Infections and infestations None View
Tachypnoea None Respiratory, thoracic and mediastinal disorders None View
Tinea Infection None Infections and infestations None View
Tremor None Nervous system disorders None View
Upper Respiratory Infection None Infections and infestations None View
Urinary Tract Infection None Infections and infestations None View