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 @ 5:25 PM
Ignite Modification Date: 2025-12-25 @ 2:59 PM
NCT ID: NCT01599650
Description: None
Frequency Threshold: 2
Time Frame: [1] Safety set was summarized based on actual treatment received. There were 3 laser monotherapy patients who received ranibizumab and 1 ranibizumab patient who received laser treatment which resulted in percentages > 100% for the ranibizumab + laser arm.
Study: NCT01599650
Study Brief: Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in 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
Ranibizumab 0.5mg Ranibizumab 0.5mg None None 30 180 112 180 View
Ranibizumab 0.5mg + Laser Ranibizumab 0.5mg + Laser \[1\] Safety set was summarized based on actual treatment received. There were 3 laser monotherapy patients who received ranibizumab and 1 ranibizumab patient who received laser treatment which resulted in percentages \> 100% for the ranibizumab + laser arm. None None 33 183 121 183 View
Laser Monotherapy With Ranibizumab 0.5 mg From Month 6 Laser monotherapy with Ranibizumab 0.5 mg from Month 6 None None 10 63 40 63 View
Laser Monotherapy Without Ranibizumab 0.5 mg From Month 6 Laser monotherapy without Ranibizumab 0.5 mg from Month 6 None None 3 25 14 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Periprosthetic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Intraocular pressure increased (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Intraocular pressure increased (Study eye) SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Retinal aneurysm (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinopathy (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual acuity reduced (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous haemorrhage (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diverticulum intestinal haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Large intestine polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Gallbladder disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hepatic mass SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dengue fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Perichondritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Facial bones fracture (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Burnout syndrome SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Prerenal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure chronic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urethral stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Coronary artery embolism SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cataract (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Macular fibrosis (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Macular hole (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Colorectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Gastrointestinal carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Basal ganglia stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermatitis bullous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Aortic valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Blepharitis (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Blepharitis (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctival haemorrhage (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctivitis allergic (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Corneal erosion (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cystoid macular oedema (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry eye (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry eye (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
Eye pruritus (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eyelid oedema (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Glaucoma (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lacrimation increased (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Macular fibrosis (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Macular oedema (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Metamorphopsia (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular hyperaemia (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular hypertension (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular hypertension (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Photopsia (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Posterior capsule opacification (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Punctate keratitis (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal haemorrhage (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal ischaemia (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal neovascularisation (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal vein occlusion (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 adhesions (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous detachment (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous floaters (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous haemorrhage (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Conjunctivitis (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Conjunctivitis (Study eye) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Intraocular pressure increased (Study eye) SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Visual field defect (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Phlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View