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:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-25 @ 4:54 PM
NCT ID:
NCT03754803
Description:
In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study.
The analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.
Frequency Threshold:
0
Time Frame:
Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.
Study:
NCT03754803
Study Brief:
Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Pre-treated Participants | Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label. | 2 | None | 78 | 337 | 0 | 337 | View |
| ART-naive Participants | Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label. | 0 | None | 1 | 31 | 0 | 31 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Skull fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Bladder transitional cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | View |
| Kaposi's sarcoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.0 | View |
| Embolism arterial | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v22.0 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v22.0 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v22.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v22.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v22.0 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v22.0 | View |
| Ischaemic cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v22.0 | View |
| Fanconi syndrome | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v22.0 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v22.0 | View |
| Macular degeneration | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v22.0 | View |
| Macular hole | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v22.0 | View |
| Obstructive pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v22.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v22.0 | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v22.0 | View |
| Anal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Medical device site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Pneumococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v22.0 | View |
| Craniocerebral injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Tendon rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Toxicity to various agents | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v22.0 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v22.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | View |
| Joint effusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | View |
| Anal squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | View |
| Laryngeal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | View |
| Malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | View |
| Lung adenocarcinoma stage IV | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | View |
| Malignant melanoma in situ | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | View |
| Oropharyngeal neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.0 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v22.0 | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA v22.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v22.0 | View |
| Drug abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v22.0 | View |
| Schizophrenia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v22.0 | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v22.0 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.0 | View |
| Cervical dysplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v22.0 | View |
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | View |
| Pulmonary thrombosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v22.0 | View |
| Family stress | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA v22.0 | View |
| Cardioversion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v22.0 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v22.0 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v22.0 | View |
Other Events(If Any):