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 1 Raltegravir / 3TC (MK0518B) | Raltegravir / 3TC (MK0518B ) (50 patients) Raltegravir/3TC: MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information. | 1 | None | 3 | 49 | 12 | 49 | View |
| Group 2 Standard Combination Therapy | NNRTI-Based Regimen: • EFV/TDF/FTC PI-Based Regimens: ATV/r + TDF/FTC or DRV/r + TDF/FTC INSTI-Based Regimens: DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC NNRTI-Based Regimens: EFV plus ABC/3TC or RPV/TDF/FTC PI-Based Regimen: ATV/r plus ABC/3TC PI-Based Regimens: DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC INSTI-Based Regimen: RAL plus ABC/3TC And other ART regimens EFV/TDF/FTC: standard combination therapy ATV/r + TDF/FTC or DRV/r + TDF/FTC DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC EFV plus ABC/3TC or RPV/TDF/FTC ATV/r plus ABC/3TC DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC RAL plus ABC/3TC Other ART regimens | 0 | None | 3 | 25 | 10 | 25 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Altered blood test | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Prostate Neoplasia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | View |
| hilar adenopathies and anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Melanoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | View |
| Hernia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | View |
| febrile syndrome | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Amigdalitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Ansiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Lues | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Common cold | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |