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 @ 3:06 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT01177059
Description: The safety population included all participants who were enrolled in the original OTH/OZ1-INT-1 study and continued participation in the long term follow-up OZ1-HV1-202/OZ1HIV2001 study.
Frequency Threshold: 0
Time Frame: Approximately up to 15 years
Study: NCT01177059
Study Brief: Long Term Follow-Up Study of Human Immunodeficiency Virus Type 1 (HIV-1) Positive Patients Who Have Received OZ1 Gene Therapy as Part of a Clinical Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Anti-HIV-1 Ribozyme (OZ1) Transduced Cells Participants who received an infusion of final cell product (that is, a cluster of differentiation \[CD\]34+ cells with or without gene transfer product) in the original study (OTH/OZ1-INT-1) were followed up in this study. 0 None 7 68 1 68 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Skin Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 20.0 View
Testicle Adenoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 20.0 View
Premature Baby NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA Version 20.0 View
Suicidal Ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 20.0 View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 20.0 View
Deep Vein Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 20.0 View
Kaposi's Sarcoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 20.0 View
Papillary Thyroid Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 20.0 View
Rib Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 20.0 View
Basal Cell Carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 20.0 View
Hodgkin's Disease NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 20.0 View