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 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 12:49 AM
NCT ID:
NCT02059434
Description:
The Safety population comprised all randomised participants who received at least one dose of investigational product.
Frequency Threshold:
5
Time Frame:
Up to 14 (±2) days after the last investigational product administration or after premature discontinuation.
Study:
NCT02059434
Study Brief:
Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and 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 |
|---|---|---|---|---|---|---|---|---|
| LAS190792 400 µg (Part 2) | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) | None | None | 0 | 35 | 9 | 35 | View |
| Placebo (Part 1) | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) | None | None | 0 | 12 | 3 | 12 | View |
| LAS190792 100 µg (Part 2) | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) | None | None | 0 | 36 | 4 | 36 | View |
| Tiotropium 18 μg | Single dose, oral inhalation by HandiHaler® single-dose dry powder inhaler (DPI) | None | None | 0 | 37 | 6 | 37 | View |
| Indacaterol 150 μg | Single dose, oral inhalation by Breezhaler® single-dose dry powder inhaler (DPI) | None | None | 0 | 37 | 15 | 37 | View |
| Placebo (Part 2) | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) | None | None | 0 | 37 | 11 | 37 | View |
| LAS190792 200 µg (Part 1) | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) | None | None | 0 | 6 | 2 | 6 | View |
| LAS190792 400 µg (Part 1) | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) | None | None | 0 | 6 | 4 | 6 | View |
| LAS190792 5 µg (Part 1) | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) | None | None | 0 | 6 | 2 | 6 | View |
| LAS190792 20 µg (Part 1) | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) | None | None | 0 | 6 | 3 | 6 | View |
| LAS190792 50 µg (Part 1) | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) | None | None | 1 | 6 | 1 | 6 | View |
| LAS190792 100 µg (Part 1) | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) | None | None | 0 | 6 | 2 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Scrotal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.1 | View |
| Aphthous stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
| Vessel puncture site bruise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Eye contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Ligament rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Tooth injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Dizziness postural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |