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 @ 9:08 PM
Ignite Modification Date: 2025-12-25 @ 6:58 PM
NCT ID: NCT00733304
Description: Safety Population was used to collect AE and SAE data
Frequency Threshold: 5
Time Frame: AEs and SAEs were collected approximately up to 6 months
Study: NCT00733304
Study Brief: An Extension to Study MD7108240
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
2 mg/mL TID Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months. 0 None 1 15 9 15 View
5 mg/mL QD Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months. 0 None 0 8 3 8 View
5 mg/mL TID Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months. 0 None 2 19 15 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Keratoconjunctivitis sicca SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract nuclear SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Optic disc haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Photopsia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Posterior capsule opacification SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Sensation of foreign body SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View