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 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
NCT ID:
NCT02358369
Description:
During the Washout Period (4 to 6 weeks) prior to randomization, adverse event data were collected for all participants in a single arm.
During the entire 24 weeks of treatment (consisting of Treatment Periods A, B and C), adverse event data were not collected by the intervention received, but instead, according to the arm participants were randomized to at the start of Treatment Period A (Week 0).
Frequency Threshold:
5
Time Frame:
Adverse event data were collected for a period of 28 to 30 weeks, from the beginning of the Washout Period (starting on Week -6 to -4) to the end of study (Week 24).
Study:
NCT02358369
Study Brief:
Dose-Ranging Study of the Bimatoprost Ocular Insert
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Washout + Placebo Ocular Insert | Glaucoma medication washout and placebo ocular insert in each eye for 4 to 6 weeks prior to randomization. | None | None | 0 | 156 | 9 | 156 | View |
| 13 mg Bimatoprost Ocular Insert | Following the washout period, 13 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 13 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks. | None | None | 1 | 41 | 20 | 41 | View |
| Placebo Ocular Insert + Timolol 0.5% | Following the washout period, timolol ophthalmic solution 0.5% twice a day in each eye plus placebo ocular inserts in each eye for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the placebo ocular inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Inserts for 12 weeks. | None | None | 3 | 40 | 16 | 40 | View |
| 2.2 mg Bimatoprost Ocular Insert | Following the washout period, 2.2 mg Bimatoprost Ocular Insert in each eye plus placebo eye drops in each eye twice a day for 6 weeks in Treatment Period A. In Treatment Period B participants continued to wear the 2.2 mg Bimatoprost Ocular Inserts for 6 weeks but the eye drops were discontinued. In Treatment Period C all participants were fitted with 13 mg Bimatoprost Ocular Insert in each eye for 12 weeks. | None | None | 1 | 40 | 12 | 40 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.0) | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| Brain hypoxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Conjunctival hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (16.0) | View |
| Eye discharge | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (16.0) | View |
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (16.0) | View |
| Punctate keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (16.0) | View |
| Conjunctival haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (16.0) | View |
| Eye irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (16.0) | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (16.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.0) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (16.0) | View |