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 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
NCT ID:
NCT03608033
Description:
Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.
Frequency Threshold:
0
Time Frame:
The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit
Study:
NCT03608033
Study Brief:
Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| OMS721 | Administration of OMS721 OMS721: Biological: OMS721 | 0 | None | 22 | 181 | 137 | 181 | View |
| Placebo | Administration of Vehicle (D5W or Saline Solution) Vehicle (D5W or saline): 5% Dextrose in water or normal saline solution | 1 | None | 20 | 179 | 121 | 179 | View |
| Open-Label OMS721 | Subgroup of patients from blinded (either treatment group) who subsequently received open-label OMS721 during the open-label period OMS721: Biological: OMS721 | 0 | None | 7 | 34 | 25 | 34 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| SAE by System Organ | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Product Issues | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| AE by System Organ | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |