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 @ 11:52 AM
Ignite Modification Date:
2025-12-25 @ 11:53 AM
NCT ID:
NCT01189461
Description:
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold:
0
Time Frame:
None
Study:
NCT01189461
Study Brief:
Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Macugen | Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48. | None | None | 3 | 46 | 16 | 46 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lung neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15.0 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v15.0 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v15.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v15.0 | View |
| Conjunctival haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v15.0 | View |
| Eye discharge | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v15.0 | View |
| Eye pruritus | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v15.0 | View |
| Maculopathy | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v15.0 | View |
| Visual acuity reduced | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v15.0 | View |
| Gastric polyps | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v15.0 | View |
| Hiatus hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v15.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v15.0 | View |
| Carcinoembryonic antigen increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v15.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v15.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v15.0 | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v15.0 | View |
| Conjunctival hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v15.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v15.0 | View |
| Eye pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v15.0 | View |
| Eyelid ptosis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v15.0 | View |
| Macular oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v15.0 | View |
| Uveitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v15.0 | View |
| Vitreous floaters | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v15.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v15.0 | View |
| Gastrointestinal hypermotility | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v15.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v15.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v15.0 | View |
| Biopsy vocal cord | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v15.0 | View |
| Intraocular pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v15.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v15.0 | View |
| Renal colic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v15.0 | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | View |
| Skin reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v15.0 | View |