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:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
NCT ID:
NCT00491894
Description:
None
Frequency Threshold:
3
Time Frame:
6 months
Study:
NCT00491894
Study Brief:
Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Patients With Chronic Drooling | A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID | None | None | 14 | 137 | 122 | 137 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Urinary tract infection | None | Infections and infestations | MedDRA Version 10.0 | View |
| Otitis media | None | Infections and infestations | MedDRA Version 10.0 | View |
| Cellulitis | None | Infections and infestations | MedDRA Version 10.0 | View |
| Impaired gastric emptying | None | Gastrointestinal disorders | MedDRA Version 10.0 | View |
| Nystagmus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 10.0 | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 10.0 | View |
| Hydrocephalus | None | Nervous system disorders | MedDRA Version 10.0 | View |
| Anoxic encephalopathy | None | Nervous system disorders | MedDRA Version 10.0 | View |
| Esophageal candidiasis | None | Infections and infestations | MedDRA Version 10.0 | View |
| Tonsillar hypertrophy | None | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | View |
| Pneumonia aspiration | None | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | View |
| Aspiration | None | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | View |
| Dehydration | None | Metabolism and nutrition disorders | MedDRA Version 10.0 | View |
| Multi-organ failure | None | General disorders | MedDRA Version 10.0 | View |
| Gastrointestinal motility disorder | None | Gastrointestinal disorders | MedDRA Version 10.0 | View |
| Therapeutic agent toxicity | None | Injury, poisoning and procedural complications | MedDRA Version 10.0 | View |
| Pneumonia | None | Infections and infestations | MedDRA Version 10.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | None | Gastrointestinal disorders | MedDRA Version 10.0 | View |
| Diarrhea | None | Gastrointestinal disorders | MedDRA Version 10.0 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA Version 10.0 | View |
| Dry mouth | None | Gastrointestinal disorders | MedDRA Version 10.0 | View |
| Lip dry | None | Gastrointestinal disorders | MedDRA Version 10.0 | View |
| Otitis media | None | Infections and infestations | MedDRA Version 10.0 | View |
| Urinary tract infection | None | Infections and infestations | MedDRA Version 10.0 | View |
| Upper respiratory tract infection | None | Infections and infestations | MedDRA Version 10.0 | View |
| Influenza | None | Infections and infestations | MedDRA Version 10.0 | View |
| Pharyngitis streptococcal | None | Infections and infestations | MedDRA Version 10.0 | View |
| Sinusitis | None | Infections and infestations | MedDRA Version 10.0 | View |
| Gastroenteritis viral | None | Infections and infestations | MedDRA Version 10.0 | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA Version 10.0 | View |
| Viral upper respiratory tract infection | None | Infections and infestations | MedDRA Version 10.0 | View |
| Nasal congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | View |
| Upper respiratory tract congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | View |
| Convulsion | None | Nervous system disorders | MedDRA Version 10.0 | View |
| Somnolence | None | Nervous system disorders | MedDRA Version 10.0 | View |
| Headache | None | Nervous system disorders | MedDRA Version 10.0 | View |
| Pyrexia | None | General disorders | MedDRA Version 10.0 | View |
| Irritability | None | General disorders | MedDRA Version 10.0 | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA Version 10.0 | View |
| Feeding tube complication | None | Injury, poisoning and procedural complications | MedDRA Version 10.0 | View |
| Procedural pain | None | Injury, poisoning and procedural complications | MedDRA Version 10.0 | View |
| Flushing | None | Vascular disorders | MedDRA Version 10.0 | View |
| Restlessness | None | Psychiatric disorders | MedDRA Version 10.0 | View |
| Urine output decreased | None | Investigations | MedDRA Version 10.0 | View |
| Dysuria | None | Renal and urinary disorders | MedDRA Version 10.0 | View |