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 |
|---|---|---|---|---|---|---|---|---|
| Methadone Maintenance Therapy | Referral to methadone maintenance therapy for treatment of opioid dependence. Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT. | 3 | None | 4 | 140 | 3 | 140 | View |
| Buprenorphine/Naloxone | Office based treatment of opioid dependence with buprenorphine/naloxone Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician. | 7 | None | 10 | 141 | 23 | 141 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Accident, trauma, or external factor | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Respiratory | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Nephrogenic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| AIDS-related | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| None | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Psychiatric | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Suicide attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abnormal lab result | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Suspected infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Vascular | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Cardiac | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Gastrointestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Allergic reaction (non-study medication) | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Unintentional injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |