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: 2025-12-25 @ 2:37 AM
Ignite Modification Date: 2025-12-26 @ 1:15 AM
NCT ID: NCT01085734
Description: None
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT01085734
Study Brief: Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1 Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros None None 4 15 13 15 View
Group 2 Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns. None None 3 15 15 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
esophageal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
viral influenza SYSTEMATIC_ASSESSMENT Immune system disorders None View
osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
organ transplant rejection SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
worsening of cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
worsening of hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Meniere's disease SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
generalized weakness SYSTEMATIC_ASSESSMENT General disorders None View
increased intraocular pressure SYSTEMATIC_ASSESSMENT Eye disorders None View
worsening of epiretinal membrane SYSTEMATIC_ASSESSMENT Eye disorders None View
subconjunctival hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
contusion left foot SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
sinusitis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
inner ear infection SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders None View
infection left foot SYSTEMATIC_ASSESSMENT Infections and infestations None View
auditory disturbance SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
puncture wounds to hands SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
blurry vision SYSTEMATIC_ASSESSMENT Eye disorders None View
tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
discomfort right eye SYSTEMATIC_ASSESSMENT Eye disorders None View
nonfunctioning gallbladder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
cholescystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
headache SYSTEMATIC_ASSESSMENT General disorders None View
nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View