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:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
NCT ID:
NCT05458102
Description:
All-cause mortality: All Enrolled Analysis Set included all participants who received study participant identification number in study after screening. Cohort 1: No treatment group is reported for 1 participant who was enrolled but never treated.
Adverse Events: Safety Analysis Set included all participants who took at least 1 dose of study drug. Per planned analysis, Adverse Events/All-cause mortality were summarized by study treatments administered in Cohort 1 and Cohort 2 per period.
Frequency Threshold:
5
Time Frame:
Adverse Events and All-cause mortality: Up to 77 days for Cohort 1 and up to 54 days for Cohort 2
Study:
NCT05458102
Study Brief:
Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 1: Vesatolimod 2 mg | Participants received a single dose of VES 2 mg on Day 1 of Period 1. | 0 | None | 0 | 15 | 2 | 15 | View |
| Cohort 1: Cobicistat 150 mg | Participants received COBI 150 mg once daily on Days 1 to 5 in Period 2. | 0 | None | 0 | 13 | 5 | 13 | View |
| Cohort 1: Vesatolimod 2 mg + Cobicistat 150 mg | Participants received COBI 150 mg once along with a single dose of VES 2 mg on Day 2 in Period 2. | 0 | None | 0 | 13 | 0 | 13 | View |
| Cohort 1: Voriconazole 400 mg | Participants received a loading dose of VOR 400 mg twice daily on Day 1 in Period 3. | 0 | None | 0 | 11 | 4 | 11 | View |
| Cohort 1: Voriconazole 200 mg | Participants received VOR 200 mg twice daily on Days 2 to 6 in Period 3. | 0 | None | 0 | 11 | 1 | 11 | View |
| Cohort 1: Vesatolimod 2 mg + Voriconazole 200 mg | Participants received VOR 200 mg twice along with a single dose of VES 2 mg on Day 3 in Period 3. | 0 | None | 0 | 11 | 1 | 11 | View |
| Cohort 1: No Treatment | Participant was enrolled but was not dosed. | 0 | None | 0 | 0 | 0 | 0 | View |
| Cohort 2: Vesatolimod 6 mg | Participants received a single dose of VES 6 mg on Day 1 in Period 1. | 0 | None | 0 | 2 | 0 | 2 | View |
| Cohort 2: Rifabutin 300 mg | Participants received RFB 300 mg once daily on Days 1 to 9 in Period 2. | 0 | None | 0 | 2 | 1 | 2 | View |
| Cohort 2: Vesatolimod 6 mg + Rifabutin 300 mg | Participants received RFB 300 mg once along with a single dose of VES 6 mg on Day 6 in Period 2. | 0 | None | 0 | 2 | 1 | 2 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Photopsia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.1 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Cytokine release syndrome | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.1 | View |