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 @ 11:31 PM
Ignite Modification Date: 2025-12-25 @ 9:19 PM
NCT ID: NCT01712256
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected from the time of written informed consent until completion of the study at Visit 10.
Study: NCT01712256
Study Brief: Re-boosting of HIV-1 Infected Subjects With Vacc-4x
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Re-boosting With Vacc-4x Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15. Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. None None 2 33 31 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Oropharyngeal cancer stage unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
HIV infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Influenza-like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Application site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Injection site Vesicles SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Pain in extremities SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Aphthous stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View