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:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:06 AM
NCT ID:
NCT03861234
Description:
Treated Set (TS): All patients who were treated with at least one dose of BI 836880.
Frequency Threshold:
5
Time Frame:
SRD-part: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks. MRD-part: From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks. All-cause mortality: Up to 6 weeks for SRD-part, up to 24 weeks for MRD-part.
Study:
NCT03861234
Study Brief:
A Study to Test Different Doses of BI 836880 in Patients With an Eye Disease Called Wet Age-related Macular Degeneration (wAMD)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 0.06 mg BI 836880 - SRD Part | 0.06 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD). | 0 | None | 1 | 3 | 1 | 3 | View |
| 0.5 mg BI 836880 - SRD Part | 0.5 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD). | 0 | None | 0 | 3 | 1 | 3 | View |
| 1 mg BI 836880 - SRD Part | 1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD). | 0 | None | 0 | 3 | 1 | 3 | View |
| 1 mg BI 836880 - Cohort 1 MRD Part | 1 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-resistant wet age-related macular degeneration (wAMD). | 0 | None | 2 | 10 | 8 | 10 | View |
| 2 mg BI 836680 - Cohort 2 MRD Part | 2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients with treatment-naïve wAMD. | 0 | None | 0 | 4 | 2 | 4 | View |
| 2 mg BI 836680 - Cohort 3 MRD Part | 2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as three IVT injections on Day 1, Day 29 and Day 57, in patients within 3 years of initial wAMD. | 0 | None | 4 | 13 | 11 | 13 | View |
| 0.18 mg BI 836880 - SRD Part | 0.18 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD). | 0 | None | 0 | 3 | 0 | 3 | View |
| 2 mg BI 836880 - SRD Part | 2 mg BI 836880 solution for intravitreal (IVT) injection with diluent for BI 836880 concentrate for solution for injection 80mg/mL, 10 mL vial was administered as single IVT injection on Day 1, in patients with treatment-resistant wet age-related macular degeneration (wAMD). | 0 | None | 0 | 3 | 2 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neovascular age-related macular degeneration | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Retinal occlusive vasculitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Depressed fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Squamous cell carcinoma of skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Anterior chamber cell | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Cataract subcapsular | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Conjunctival haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Eye inflammation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Foreign body sensation in eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Lenticular opacities | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Meibomian gland dysfunction | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Ocular discomfort | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Punctate keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Retinal haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Retinal oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Subretinal fluid | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Visual acuity reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Vitreal cells | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Vitreous detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Vitreous floaters | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Vitreous haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Vitreous opacities | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Chorioretinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Cataract operation complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Corneal abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Foreign body in eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood creatine phosphokinase MB increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood folate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood potassium increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Electrocardiogram T wave inversion | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Heart rate irregular | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Oxygen saturation abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Tear break up time decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 26.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Pigmentation disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| Labile hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| Peripheral venous disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |