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 |
|---|---|---|---|---|---|---|---|---|
| Genotype 1a -Rx Naive -no NS5A Polymorph | Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description | 0 | None | 0 | 3 | 0 | 3 | View |
| Genotype 1a/1b -Prior INF or NS3/4A | Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description | 0 | None | 0 | 0 | 0 | 0 | View |
| Genotype 4- Prior Treatment | Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description | 0 | None | 0 | 0 | 0 | 0 | View |
| Genotype 1a, Rx Naive + NS5A Polymorph | Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description | 0 | None | 0 | 0 | 0 | 0 | View |
| Genotype 1b - Rx Naive | Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description | 0 | None | 0 | 1 | 0 | 1 | View |
| Genotype4 - Treatment Naive | (e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description | 0 | None | 0 | 0 | 0 | 0 | View |