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 @ 11:58 AM
Ignite Modification Date:
2025-12-25 @ 11:56 AM
NCT ID:
NCT02347761
Description:
A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last does of study medication. A treatment emergent SAE is an on-treatment SAE
Frequency Threshold:
5
Time Frame:
Week 0-12
Study:
NCT02347761
Study Brief:
Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer | None | None | 10 | 218 | 37 | 218 | View |
| Placebo BID eFlow (CS) Nebulizer | Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer | None | None | 11 | 218 | 38 | 218 | View |
| SUN-101 25 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer | None | None | 8 | 217 | 23 | 217 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| diastolic dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| gallbladder necrosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| emphysematous cholecystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| lobar pheumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 15.1 | View |
| pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| intentional overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| obstructive uropathy | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| coronary artery stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| antiphospholiid antibodies | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| lung adenocarcinoma stage IV | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| malignant neoplasm of pleura metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| carotid artery stenosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| lacunar infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |