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 @ 4:36 PM
Ignite Modification Date:
2025-12-25 @ 2:26 PM
NCT ID:
NCT04513366
Description:
Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Frequency Threshold:
5
Time Frame:
Day 1 up to approximately 12 months
Study:
NCT04513366
Study Brief:
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SEL-212A (Low-dose) | SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months. | 0 | None | 10 | 37 | 31 | 37 | View |
| SEL-212B (High-dose) | SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months. | 1 | None | 5 | 38 | 29 | 38 | View |
| Placebo | Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months. | 0 | None | 2 | 37 | 27 | 37 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V25.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V25.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V25.1 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V25.1 | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA V25.1 | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V25.1 | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA V25.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V25.1 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA V25.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA V25.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V25.1 | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V25.1 | View |
| Periodontitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V25.1 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA V25.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA V25.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA V25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V25.1 | View |
| Hypertriglycerideaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V25.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V25.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V25.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V25.1 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V25.1 | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V25.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA V25.1 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA V25.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA V25.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA V25.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V25.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V25.1 | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V25.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA V25.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA V25.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA V25.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V25.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V25.1 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V25.1 | View |
| Gouty tophus | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA V25.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA V25.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA V25.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA V25.1 | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA V25.1 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA V25.1 | View |