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 @ 7:58 PM
Ignite Modification Date: 2025-12-25 @ 5:32 PM
NCT ID: NCT04634604
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected throughout the study until study completion, up to 1 year (terminated early).
Study: NCT04634604
Study Brief: A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bevacizumab For infants randomized to bevacizumab, the Intravitreous bevacizumab 0.063 mg injection will be given no later than 2 days after the diagnosis of type 1 ROP. The ophthalmologist may choose to give the intravitreous injection in the operating room or at the bedside, with or without anesthesia, after consultation with the attending neonatologist. A binocular indirect ophthalmoscope with an appropriate condensing lens should be available, and the pupils should be dilated. Bevacizumab: For infants randomized to bevacizumab, the Intravitreous bevacizumab 0.063 mg injection will be given no later than 2 days after the diagnosis of type 1 ROP. The ophthalmologist may choose to give the intravitreous injection in the operating room or at the bedside, with or without anesthesia, after consultation with the attending neonatologist. A binocular indirect ophthalmoscope with an appropriate condensing lens should be available, and the pupils should be dilated. 0 None 1 7 4 7 View
Laser For infants randomized to laser treatment, it will be given in conjunction with a binocular indirect ophthalmoscope and an appropriate condensing lens, by a study-certified ophthalmologist experienced in the use of this equipment. The treating investigator will be certified as having sufficient experience with laser for ROP, and adequacy of laser treatment will be confirmed by expert review of photographs. Special laser precautions, as mandated by Occupational Safety and Health Administration (OSHA) and facility standards, will be followed. Laser: For infants randomized to laser treatment, it will be given in conjunction with a binocular indirect ophthalmoscope and an appropriate condensing lens, by a study-certified ophthalmologist experienced in the use of this equipment. The treating investigator will be certified as having sufficient experience with laser for ROP, and adequacy of laser treatment will be confirmed by expert review of photographs. Special laser precautions, as mandated by OSHA and facility standards, will be followed. 0 None 4 9 6 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Failure to Thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory insufficiency SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Eustachian tube dysfunction SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Viral Syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
Head Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cerebral Palsy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Primary Apnea of premature newborns SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Corneal edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Esotropia SYSTEMATIC_ASSESSMENT Eye disorders None View
Myopia SYSTEMATIC_ASSESSMENT Eye disorders None View
Preretinal Hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal Hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bloody stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Electrolyte and fluid balance condition SYSTEMATIC_ASSESSMENT General disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Streptococcal infection NOS SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thrush SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral Syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oxygen Saturations Low SYSTEMATIC_ASSESSMENT Investigations None View
Fractured Ribs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteopenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neurologic disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Primary apnea of premature newborns SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tachypnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin Abrasion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View