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: 2025-12-26 @ 12:18 PM
Ignite Modification Date: 2025-12-26 @ 12:18 PM
NCT ID: NCT01940900
Description: The efficacy (ITT) population, defined as all subjects randomized and received at least one dose of study drug, is different than the safety population, where all subjects who have received at least one dose of E10030 are analyzed as on that group. There was one subject who was randomized to Sham+Ranibizumab but was mis-treated with one dose of E10030 and therefore was analyzed in the E10030+ranibizuma group for safety purposes. This is the same explanation for the SAE and Mortality tables.
Frequency Threshold: 5
Time Frame: Up to 12 months of exposure
Study: NCT01940900
Study Brief: A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
E10030 + Ranibizumab E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection E10030 ranibizumab 4 None 56 312 161 312 View
Sham + Ranibizumab E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection ranibizumab E10030 sham intravitreal injection: Pressure on the eye with a syringe with no needle 4 None 49 314 136 314 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lung carcinoma cell type unspecified stage I NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Lung neoplasm malignant NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Lung squamous cell carcinoma stage III NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Metastases to central nervous system NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Metastases to bone NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Metastases to liver NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Metastatic neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Non-small cell lung cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Oesophageal carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Squamous cell carcinoma of lung NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Breast cancer recurrent NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Malignant melanoma stage III NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDR 18.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDR 18.1 View
Device malfunction NON_SYSTEMATIC_ASSESSMENT General disorders MedDR 18.1 View
Benign prostatic hyperplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDR 18.1 View
Cataract traumatic NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDR 18.1 View
Compression fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDR 18.1 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDR 18.1 View
Femoral neck fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDR 18.1 View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDR 18.1 View
Hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDR 18.1 View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDR 18.1 View
Lumbar vertebral fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDR 18.1 View
Periprosthetic fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDR 18.1 View
Rib fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDR 18.1 View
Splenic rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDR 18.1 View
Thoracic vertebral fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDR 18.1 View
Upper limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDR 18.1 View
Wrist fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDR 18.1 View
Subdural haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDR 18.1 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDR 18.1 View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDR 18.1 View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDR 18.1 View
Atrioventricular block complete NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDR 18.1 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDR 18.1 View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDR 18.1 View
Heart valve incompetence NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDR 18.1 View
Myocardial ischaemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDR 18.1 View
Sinus node dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDR 18.1 View
Ventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDR 18.1 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDR 18.1 View
Bronchiectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDR 18.1 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDR 18.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDR 18.1 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDR 18.1 View
Pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDR 18.1 View
Cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDR 18.1 View
Ischaemic stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDR 18.1 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDR 18.1 View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDR 18.1 View
Macular hole NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDR 18.1 View
Optic ischaemic neuropathy NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDR 18.1 View
Retinal detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDR 18.1 View
Retinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDR 18.1 View
Retinal pigment epithelial tear NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDR 18.1 View
Vitreous haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDR 18.1 View
Abdominal wall haematoma NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDR 18.1 View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDR 18.1 View
Haemorrhoidal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDR 18.1 View
Inguinal hernia strangulated NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDR 18.1 View
Peptic ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDR 18.1 View
Rectal prolapse NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDR 18.1 View
Renal cyst NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDR 18.1 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDR 18.1 View
Urethral stenosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDR 18.1 View
Urinary bladder polyp NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDR 18.1 View
Cholecystitis chronic NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDR 18.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDR 18.1 View
Lumbar spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDR 18.1 View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDR 18.1 View
Spinal osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDR 18.1 View
Goitre NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDR 18.1 View
Aspergillus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Chlostridium difficile colitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Device related sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Endophthalmitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Gastrointestinal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Infectious colitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Pneumonia staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Vestibular neuronitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Urinary tract infection enterococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Hepatic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDR 18.1 View
Accelerated hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDR 18.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDR 18.1 View
Hypertensive crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDR 18.1 View
Breast Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Diffuse large B-cell lymphoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Follicle centre, lymphoma, follicular grade I, II, III stage IV NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Invasive ductal breast carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Leukaemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Lung adenocarcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDR 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Punctate keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDR 18.1 View
Conjuctival hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDR 18.1 View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDR 18.1 View
Vitreous floaters NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDR 18.1 View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDR 18.1 View
Keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDR 18.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDR 18.1 View
Intraocular pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDR 18.1 View
Conjunctival haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDR 18.1 View