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 @ 5:56 PM
Ignite Modification Date:
2025-12-25 @ 3:19 PM
NCT ID:
NCT05219968
Description:
190 participants successfully received treatment during the Week 24 Treatment Period. 6 participants who had a treatment administration failure are not included.
131 participants successfully received study treatment during the Extension Period. 5 participants who had a treatment administration failure are not included.
Frequency Threshold:
5
Time Frame:
AEs are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 52. Week 24 Treatment TEAEs: AEs that start on or after the LYR-210/Sham placement procedure but no later than 31 days after discontinuation of the first study treatment (up to 24 weeks). Extension Period TEAEs: AEs that start on or after the second placement procedure (Week 24) but no later than 31 days after discontinuation of second study treatment (up to Week 52).
Study:
NCT05219968
Study Brief:
Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| LYR-210 up to 24 Weeks | Single administration of LYR-210 drug matrix (7500 μg) LYR-210: LYR-210 drug matrix (mometasone furoate) Background Therapy: Daily Saline Irrigation | 0 | None | 4 | 124 | 78 | 124 | View |
| Sham Procedure Control up to 24 Weeks | Single mock administration procedure Sham procedure control: Sham procedure control Background Therapy: Daily Saline Irrigation | 0 | None | 4 | 66 | 26 | 66 | View |
| LYR-210-LYR-210 Extension | Repeat administration of LYR-210 at Week 24 | 0 | None | 2 | 42 | 21 | 42 | View |
| LYR-210-Sham Extension | Crossover from LYR-210 to sham procedure control at Week 24 | 0 | None | 3 | 41 | 9 | 41 | View |
| Sham-LYR-210 Extension | Crossover from sham procedure control to LYR-210 at Week 24 | 0 | None | 3 | 48 | 19 | 48 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Colonic Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | Meddra (24.1) | View |
| Medical Device Site Joint Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.1) | View |
| Rib Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.1) | View |
| Cervical Vertebral Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.1) | View |
| Pneumothorax traumatic | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.1) | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Meddra (24.1) | View |
| Tracheal Stenosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | View |
| Coronary Artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.1) | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.1) | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (24.1) | View |
| Loss of Consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | View |
| Eosinophilic pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (24.1) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.1) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (24.1) | View |
| Renal Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.1) | View |
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (24.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (24.1) | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (24.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Meddra (24.1) | View |
| Nasal Odour | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.1) | View |
| Chronis Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.1) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (24.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.1) | View |
| Acute Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (24.1) | View |