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 @ 6:42 PM
Ignite Modification Date: 2025-12-25 @ 4:13 PM
NCT ID: NCT01396057
Description: None
Frequency Threshold: 2.5
Time Frame: None
Study: NCT01396057
Study Brief: Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ranibizumab Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally None None 7 126 71 126 View
Dexamethasone Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months None None 9 118 89 118 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ATRIOVENTRICULAR BLOCK SECOND DEGREE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
BRADYARRHYTHMIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CONJUNCTIVITIS (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
OCULAR HYPERTENSION (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
ABDOMINAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
INGUINAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
LARGE INTESTINE POLYP SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
RECTAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
UMBILICAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CELLULITIS (Study eye) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
FOOT FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
KIDNEY RUPTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
PERIRENAL HAEMATOMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
ROAD TRAFFIC ACCIDENT SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
SPLENIC INJURY SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
TYPE 2 DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
INTERVERTEBRAL DISC PROTRUSION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
RHEUMATIC DISORDER SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
PROSTATE CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
RENAL CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
DIABETIC NEPHROPATHY SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
NEPHROLITHIASIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
RENAL FAILURE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
URETHRAL PROLAPSE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
SLEEP APNOEA SYNDROME SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
CIRCULATORY COLLAPSE SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABNORMAL SENSATION IN EYE (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
BLEPHARITIS (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
BLEPHARITIS (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
CATARACT (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
CONJUNCTIVAL IRRITATION (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
EYE IRRITATION (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
CYSTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
GLAUCOMA (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
MACULAR OEDEMA (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
VITREOUS FLOATERS (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
BLOOD GLUCOSE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
INTRAOCULAR PRESSURE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
INTRAOCULAR PRESSURE INCREASED (Study eye) SYSTEMATIC_ASSESSMENT Investigations MedDRA View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
VASCULAR SHUNT (Study eye) SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
CONJUNCTIVAL HAEMORRHAGE (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
CONJUNCTIVITIS (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
EYE DISCHARGE (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
EYE IRRITATION (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
EYE PAIN (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
EYELID OEDEMA (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
FOREIGN BODY SENSATION IN EYES (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
LACRIMATION INCREASED (Fellow eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
LACRIMATION INCREASED (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
OCULAR DISCOMFORT (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
OCULAR HYPERAEMIA (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
OCULAR HYPERTENSION (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
RETINAL EXUDATES (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
VISION BLURRED (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
VISUAL ACUITY REDUCED (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
VITREOUS DETACHMENT (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View