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 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
NCT ID:
NCT02247804
Description:
Safety population included all participants who received at least 1 dose of study treatment.
Frequency Threshold:
5
Time Frame:
First dose of study drug to last visit (Up to approximately 20 months)
Study:
NCT02247804
Study Brief:
Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Timolol 0.5%: Comparator | Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | 1 | None | 18 | 197 | 105 | 197 | View |
| Bimatoprost SR 15 μg | Study Eye: bimatoprost SR 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | 2 | None | 31 | 193 | 143 | 193 | View |
| Bimatoprost SR 10 μg | Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months. | 1 | None | 25 | 197 | 138 | 197 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.0 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.0 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| Trigeminal neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.0 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 22.0 | View |
| Corneal endothelial cell loss | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Corneal oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Iridocyclitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Corneal touch | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Macular oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Retinal tear | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Ulcerative keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Peptic ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Appendicitis perforated | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Post procedural sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.0 | View |
| Chondrocalcinosis pyrophosphate | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Joint instability | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Intraductal proliferative breast lesion | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| Malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| Parathyroid tumour benign | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| Hepatocellular carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| Invasive breast carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| Meningioma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| Prostate cancer recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Embolic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| VIth nerve paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 22.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| Acute pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| Pneumothorax spontaneous | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | View |
| Internal haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |
| Varicose vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |
| Hiatus hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Conjunctival hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Foreign body sensation in eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Eye irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Corneal endothelial cell loss | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Conjunctival haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Iritis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Punctate keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Corneal oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Anterior chamber cell | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Intraocular pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Visual field defect | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |