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 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
NCT ID:
NCT02603120
Description:
The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Frequency Threshold:
5
Time Frame:
First dose date up to 169 weeks plus 30 days
Study:
NCT02603120
Study Brief:
Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Double-Blind: B/F/TAF | B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food. | 2 | None | 17 | 282 | 122 | 282 | View |
| Double-Blind: ABC/DTG/3TC | ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food. | 0 | None | 26 | 281 | 132 | 281 | View |
| Open-label Extension: B/F/TAF From ABC/DTG/3TC | Participants who received ABC/DTG/3TC in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase. | 1 | None | 11 | 265 | 82 | 265 | View |
| Open-label Extension: B/F/TAF From B/F/TAF | Participants who received B/F/TAF in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase. | 1 | None | 24 | 259 | 84 | 259 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.1 | View |
| Hypertensive heart disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.1 | View |
| Myocardial bridging | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 22.1 | View |
| Macular detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Vitreous haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Colitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Haemorrhoidal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Hiatus hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Drug withdrawal syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Sudden cardiac death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 22.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 22.1 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 22.1 | View |
| Abscess limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Acute hepatitis C | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Cellulitis of male external genital organ | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Endocarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Escherichia infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Eye infection syphilitic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Large intestine infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Lymphadenitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Post procedural sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Respiratory syncytial virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Shigella infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Alcohol poisoning | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Intentional overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Toxicity to various agents | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Hypovolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Brain cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | View |
| Lung adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | View |
| Malignant neoplasm of thymus | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | View |
| Meningioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | View |
| Testicular seminoma (pure) stage I | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Hemiplegic migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Vertebrobasilar insufficiency | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Abnormal behaviour | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Alcohol abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Bipolar disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Depression suicidal | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Paranoia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Schizophrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Self-injurious ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Substance abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 22.1 | View |