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 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
NCT ID:
NCT00227305
Description:
None
Frequency Threshold:
5
Time Frame:
Other AE module includes adverse events which occurred before first dose date to last dose date + 30 days.
Study:
NCT00227305
Study Brief:
Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Quetiapine | Quetiapine 400mg/day to 800mg/day | None | None | 46 | 380 | 340 | 380 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abnormal Behaviour | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Aggression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Amoebiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Bacterial Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Bipola Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Cellulitis Staphylococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.0 | View |
| Delusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Disinhibition | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Drug Toxicity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.0 | View |
| Hallucitnation Auditory | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Hostility | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.0 | View |
| Hypertensive Crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.0 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Mania | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Myocarditis Post Infection | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.0 | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 10.0 | View |
| Perceptual Alteration Paroxysmal | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Physical Assault | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.0 | View |
| Pyschotic Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Pulmonary Hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Schizophrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Schizophrenia, Paraniod Type | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Staphylococcal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Suicide Attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| Typhoid Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| AGITATION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| IRRITABILITY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 10.0 | View |
| NASAL CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| SEDATION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0 | View |
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| INCREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 10.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |