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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT03547908
Description:
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Frequency Threshold:
5
Time Frame:
Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
Study:
NCT03547908
Study Brief:
Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Blinded Phase: B/F/TAF | Participants who were HIV-1 and HBV coinfected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks. | 2 | None | 17 | 121 | 102 | 121 | View |
| Blinded Phase: DTG + F/TDF | Participants who were HIV-1 and HBV coinfected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM B/F/TAF tablet, orally, once daily without regard to food for 96 weeks. | 1 | None | 16 | 122 | 98 | 122 | View |
| Open-Label Extension Phase: B/F/TAF From B/F/TAF | After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first. | 1 | None | 4 | 95 | 42 | 95 | View |
| Open-Label Extension Phase: B/F/TAF From DTG+F/TDF | After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first. | 0 | None | 2 | 89 | 40 | 89 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedRA 26.1 | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedRA 26.1 | View |
| Rhegmatogenous retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedRA 26.1 | View |
| Anal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 26.1 | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 26.1 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 26.1 | View |
| Haemorrhoids thrombosed | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 26.1 | View |
| Irritable bowel syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 26.1 | View |
| Lumbar hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 26.1 | View |
| Death, not otherwise specified | SYSTEMATIC_ASSESSMENT | General disorders | MedRA 26.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedRA 26.1 | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Bacterial sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Cytomegalovirus chorioretinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Dengue haemorrhagic fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Groin abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Hepatic amoebiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Meningitis cryptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Mycotoxicosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Orchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Pneumocystis jirovecii pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedRA 26.1 | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedRA 26.1 | View |
| Adenocarcinoma of colon | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 26.1 | View |
| Glottis carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 26.1 | View |
| Hepatocellular carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 26.1 | View |
| Laryngeal squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 26.1 | View |
| Sinonasal papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 26.1 | View |
| Alcoholic seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA 26.1 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedRA 26.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA 26.1 | View |
| Dermal cyst | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedRA 26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 26.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 26.1 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedRA 26.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedRA 26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedRA 26.1 | View |
| Acute hepatitis C | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Latent syphilis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Secondary syphilis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Syphilis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedRA 26.1 | View |
| Vaccination complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedRA 26.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedRA 26.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedRA 26.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedRA 26.1 | View |
| Abnormal weight gain | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedRA 26.1 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedRA 26.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedRA 26.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA 26.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedRA 26.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedRA 26.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedRA 26.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedRA 26.1 | View |