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 |
|---|---|---|---|---|---|---|---|---|
| Cognitive-behavioral Therapy for Psychosis (CBTp) | approximately 6 months of weekly individual manualized cognitive-behavior for psychosis psychotherapy in which participants are taught to set personal goals, identify problematic beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals. CBTp: approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery | None | None | 11 | 44 | 0 | 44 | View |
| Supportive Therapy (ST) | approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' life and concerns ST: approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery | None | None | 12 | 44 | 0 | 44 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalization for Medication Adjustment | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hospitalization for Foot Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hospitalization for Dehydration | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Hospitalization for Allergic Reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hospitalization for Fainting | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hospitalization for Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Surgeries | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Hospitalization for Eye Injury | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Hospitalization For Substance Use | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hospitalization for Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hospitalization Due to Psychiatric Symptom Exacerbation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hospitalization for Cardiac Problems | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |