Adverse Events Module

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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 @ 3:05 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT00950859
Description: SAEs and non-serious AEs were collected in the Safety Population, comprised of all participants that took at least one dose of DTG.
Frequency Threshold: 5
Time Frame: SAEs, non-serious AEs and laboratory toxicities were collected from start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II.
Study: NCT00950859
Study Brief: A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort I (DTG 50 mg OD) Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD). None None 10 27 25 27 View
Cohort II (DTG 50 mg BID) Participants received DTG 50 mg twice a day (BID). None None 11 24 22 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Central nervous system lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Immunoblastic lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Neurosyphilis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Febrile bone marrow aplasia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Haemochromatosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Body fat disorder SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
B-cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Brain mass SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Demyelinating polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hepatic fibrosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hepatic cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Completed suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Anogenital dysplasia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Cryoglobulinaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Dacryostenosis acquired SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Herpes virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Defaecation urgency SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Genital herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Anogenital dysplasia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Backpain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Oedema peripherial SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Intertrigo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Anogenital warts SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View