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:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
NCT ID:
NCT02354703
Description:
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
Frequency Threshold:
5
Time Frame:
16-week treatment period
Study:
NCT02354703
Study Brief:
Pharmacogenetic Study of Ondansetron in Alcohol Use 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 |
|---|---|---|---|---|---|---|---|---|
| Ondansetron--non-responsive Genotype | ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling | 0 | None | 0 | 12 | 10 | 12 | View |
| Ondansetron-responsive Genotype | ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes: if European ancestry: SLC6A4 gene: 5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT HTR3A gene: rs1150226:AG; or rs1176713:GG HTR3B gene: rs17619942:AC If African ancestry: HTR3B gene: rs176744: CC or CA SLC6A4 gene: 5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling | 0 | None | 0 | 34 | 30 | 34 | View |
| Placebo--responsive Genotype | placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes: if European ancestry: SLC6A4 gene: 5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT HTR3A gene: rs1150226:AG; or rs1176713:GG HTR3B gene: rs17619942:AC If African ancestry: HTR3B gene: rs176744: CC or CA SLC6A4 gene: 5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT Placebo: Placebo + BBCET counseling | 0 | None | 1 | 39 | 34 | 39 | View |
| Placebo--non-responsive Genotype | placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes Placebo: Placebo + BBCET counseling | 0 | None | 0 | 10 | 6 | 10 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| nervous system | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.0) | View |
| gastrointestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| musculoskeletal & connective tissue | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| skin & subcutaneous tissue | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| psychiatric | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.0) | View |
| general disorders | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| injury, poisoning, procedural | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| respiratory | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| immune | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (17.0) | View |
| eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.0) | View |
| blood & lymphatic | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| metabolism & nutrition | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.0) | View |
| reproductive & breast | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (17.0) | View |
| ear | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (17.0) | View |
| renal & urinary | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (17.0) | View |