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 @ 3:14 PM
Ignite Modification Date: 2025-12-25 @ 1:36 PM
NCT ID: NCT01568892
Description: SAEs and AEs were collected in members of Safety Population, comprised of all randomized participants who received at least one dose of study medication.
Frequency Threshold: 5
Time Frame: Serious adverse events (SAEs) and non-serious AEs were collected in the time period from the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks).
Study: NCT01568892
Study Brief: Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DTG 50mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase. 2 None 5 14 11 14 View
Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase. 0 None 4 16 14 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Cardiac death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Multiple fractures SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Brain injury SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pulmonary contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Perirectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Breast enlargement SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Macule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Mood altered SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Nephropathy toxic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vaginal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Genital herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Helicobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Syphilis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urethritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nasal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Local swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Haemorrhagic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Ejaculation delayed SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Peyronie's disease SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View