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 @ 5:57 PM
Ignite Modification Date:
2025-12-25 @ 3:20 PM
NCT ID:
NCT00528268
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00528268
Study Brief:
Study to Evaluate Sodium Phenylbutyrate in Pre-symptomatic Infants 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 2 | Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months. | None | None | 7 | 8 | 8 | 8 | View |
| Cohort 1 | Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months. | None | None | 6 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Daily Vomiting | None | Gastrointestinal disorders | None | View |
| GE Reflux | None | Gastrointestinal disorders | None | View |
| Upper Respiratory Infection | None | Infections and infestations | None | View |
| Anemia of Chronic Disease | None | Blood and lymphatic system disorders | None | View |
| Lung Collapse | None | Respiratory, thoracic and mediastinal disorders | None | View |
| G-tube | None | Gastrointestinal disorders | None | View |
| Bradycardia | None | Cardiac disorders | None | View |
| Pneumonia | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Failure to swallow | None | Gastrointestinal disorders | None | View |
| ALTE | None | General disorders | None | View |
| Nystagmus | None | Nervous system disorders | None | View |
| Dehydration | None | General disorders | None | View |
| Gastritis | None | Gastrointestinal disorders | None | View |
| Metabolic Acidosis | None | Metabolism and nutrition disorders | None | View |
| Recurrent Reflux | None | Gastrointestinal disorders | None | View |
| Fever | None | General disorders | None | View |
| Increased Secretions | None | General disorders | None | View |
| Death | None | General disorders | None | View |
| Medication Error | None | Investigations | None | View |
| Lethargy | None | General disorders | None | View |
| Foot and Mouth Disese | None | Infections and infestations | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Serous Otitis Media Bilateral | None | Infections and infestations | None | View |
| Eye Infection | None | Infections and infestations | None | View |
| Upper Respiratory Infection | None | Infections and infestations | None | View |
| Flu symptoms | None | Infections and infestations | None | View |
| Rhinitis | None | Infections and infestations | None | View |
| Encephalopathy | None | Infections and infestations | None | View |
| Swelling | None | General disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Thrush | None | Infections and infestations | None | View |
| Left Wrist drop | None | Musculoskeletal and connective tissue disorders | None | View |
| Atelectasis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Cellulitis | None | Infections and infestations | None | View |
| Increased Secretion | None | General disorders | None | View |
| Gasteroenteritis | None | Gastrointestinal disorders | None | View |
| Fracture | None | Injury, poisoning and procedural complications | None | View |
| Increased Heart Rate | None | Investigations | None | View |
| Nasal Congestion | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Spontaneous Drop in Saturations | None | Investigations | None | View |
| Muscle Weakness | None | Musculoskeletal and connective tissue disorders | None | View |
| Zinc Deficiency | None | Investigations | None | View |
| Reflux | None | Gastrointestinal disorders | None | View |
| Hand foot mouth disease | None | Infections and infestations | None | View |
| Gastritis | None | Gastrointestinal disorders | None | View |
| strep throat | None | Infections and infestations | None | View |
| Unable to Eat | None | Gastrointestinal disorders | None | View |
| Infected Cyst | None | Infections and infestations | None | View |
| Placement of bilateral ear tubes | None | Ear and labyrinth disorders | None | View |
| H1N1 | None | Infections and infestations | None | View |
| Pneumonia | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Sinus Infection | None | Infections and infestations | None | View |
| Rash | None | Skin and subcutaneous tissue disorders | None | View |
| Blank Stare | None | General disorders | None | View |