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 |
|---|---|---|---|---|---|---|---|---|
| Randomized Phase Treatment Group 1: LEN + TAB + ZAB | Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and Q6M up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL are given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks. | 0 | None | 0 | 53 | 40 | 53 | View |
| Randomized Phase Treatment Group 3: SBR | Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study are given the option to participate in the Extension Phase to switch from ART to LEN, TAB and ZAB, every 26 weeks at the dose specified for Treatment Group 1. | 0 | None | 1 | 27 | 4 | 27 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pancreatic carcinoma metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |
| Injection site mass | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |
| Injection site nodule | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |