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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group Therapy Plus Psilocybin | Modified brief Supportive-Expressive Group Therapy will be administered as ten twice-weekly sessions. Oral psilocybin will be administered once in a clinical setting. Psilocybin: One individual oral psilocybin treatment session Modified brief Supportive Expressive Group Therapy: Ten sessions of twice-weekly manualized group therapy | 0 | None | 3 | 18 | 18 | 18 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NIH DAIDS v2.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NIH DAIDS v2.0 | View |
| Stimulant-induced psychosis | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NIH DAIDS v2.0 | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NIH DAIDS v2.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NIH DAIDS v2.0 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypertension (severe, asymptomatic) | SYSTEMATIC_ASSESSMENT | Vascular disorders | NIH DAIDS v2.0 | View |
| Hypertension (moderate) | SYSTEMATIC_ASSESSMENT | Vascular disorders | NIH DAIDS v2.0 | View |
| Anxiety / Anxiety Exacerbation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NIH DAIDS v2.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NIH DAIDS v2.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NIH DAIDS v2.0 | View |
| Paranoia / Ideas of Reference | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NIH DAIDS v2.0 | View |
| Motor agitation / Restlessness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NIH DAIDS v2.0 | View |
| Unsteady gait / Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NIH DAIDS v2.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NIH DAIDS v2.0 | View |
| Thought disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NIH DAIDS v2.0 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NIH DAIDS v2.0 | View |
| Visual changes (complaint) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NIH DAIDS v2.0 | View |
| Headache (post-medication visit) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NIH DAIDS v2.0 | View |
| Fatigue (post-medication visit) | SYSTEMATIC_ASSESSMENT | General disorders | NIH DAIDS v2.0 | View |
| Insomnia (post-medication visit) | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NIH DAIDS v2.0 | View |
| Anxiety exacerbation (post-medication visit) | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NIH DAIDS v2.0 | View |
| Post-traumatic stress flashback (post-medication visit) | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NIH DAIDS v2.0 | View |
| Nausea (post-medication visit) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NIH DAIDS v2.0 | View |