Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 1:41 PM
Ignite Modification Date: 2025-12-25 @ 12:37 PM
NCT ID: NCT04880395
Description: None
Frequency Threshold: 0
Time Frame: 52 weeks
Study: NCT04880395
Study Brief: Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental : Dolutegravir Plus Lamivudine Dolutegravir 50 mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD 4 None 15 152 37 152 View
Active Comparator : TDF/XTC Plus Dolutegravir (XTC Stands for Lamivudine OR Emtricitabine) * TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD, OR * TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD Data related to the use of TDF/3TC or TDF/FTC was not discriminated. Both options used were considered as a single treatment arm: TDF/XTC plus dolutegravir. 2 None 9 77 21 77 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tuberculosis meningoencephalitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
IRIS in tuberculous meningitis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Possible lymphoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bilateral pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bilateral herpetic retinitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Burkitt's lymphoma (non-Hodgkin's lymphoma) SYSTEMATIC_ASSESSMENT Immune system disorders None View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Probable aortic aneurysm rupture SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Lymphoproliferative disorder with metástasis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Ureteral rupture SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Disseminated TB with meningeal involvement SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastrointestinal Infection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cytomegalovirus chorioretinitis and vitritis SYSTEMATIC_ASSESSMENT Eye disorders None View
Car accident SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization for investigation of pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Investigation of fever, disorientation and weight loss SYSTEMATIC_ASSESSMENT Immune system disorders None View
Esophagus substenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Renal tubular acidosis + Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pancytopenia febrile SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Probable pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neurotoxoplasmosis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cryptosporidiosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depressive symptoms/Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Abdominal pain/Epigastralgia/Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Elevated transaminases SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Amylase elevation SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Creatinine increase SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Malassezia folliculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypercholesterolemia/ Dyslipidemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Plateletopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Aphthous stomatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Insomnia/Nightmares SYSTEMATIC_ASSESSMENT General disorders None View
Itching/Rash/Prurigo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hiperglucemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
IRIS in Tuberculous meningitis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Disseminated Tuberculosis with meningeal involvement SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pharmacodermia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cytomegalovirus retinitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Histoplasmosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Bilateral cervical lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Pancytopenia febrile SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fever, diarrhea, abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Generalized Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lipid increase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Herpes Zoster SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Epigastric pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Ulcer in the left ear SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Glutamic Oxaloacetic Transaminase increase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View