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 @ 9:40 PM
Ignite Modification Date: 2025-12-25 @ 7:22 PM
NCT ID: NCT01025232
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01025232
Study Brief: A Study of Intravitreal Injections of 2.0mg Ranibizumab in Subjects With Chronic Fluid On OCT Post Multiple Injections With Ranibizumab (Super-dose Anti-VEgf SAVE 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
4 Week Re-treatment Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment. Ranibizumab: Intravitreal Injection of 2.0mg formulation None None 7 46 18 46 View
6 Week Re-treatment Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment. Ranibizumab: Intravitreal Injection of 2.0mg formulation None None 10 42 8 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death None Cardiac disorders None View
Myocardial Infarction None Cardiac disorders None View
Arrhythmia None Cardiac disorders None View
Idiopathic internal bleeding None Blood and lymphatic system disorders None View
Pneumonia None Respiratory, thoracic and mediastinal disorders None View
Pancreatic cancer None Hepatobiliary disorders None View
Lung cancer None Respiratory, thoracic and mediastinal disorders None View
Hip fracture None Musculoskeletal and connective tissue disorders None View
Cellulitis None Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
RPE rip None Eye disorders None View
Subretinal hemorrhage None Eye disorders None View
Vitreous hemorrhage None Eye disorders None View
Vein occlusion None Eye disorders None View
Increase in NS None Eye disorders None View
Increase in PSC None Eye disorders None View
Cataract surgery None Eye disorders None View
PVD None Eye disorders None View