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 @ 2:39 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
NCT ID:
NCT01018134
Description:
None
Frequency Threshold:
3
Time Frame:
6 months
Study:
NCT01018134
Study Brief:
Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Desoximetasone 0.05% Twice Daily | Desoximetasone topical spray 0.05% administered twice daily to affected area Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days | None | None | 0 | 31 | 2 | 31 | View |
| Desoximetasone 0.25% Once Daily | Desoximetasone topical spray 0.25% administered once daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days | None | None | 0 | 30 | 7 | 30 | View |
| Vehicle Once Daily | Vehicle administered to affected areas once daily Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days | None | None | 0 | 15 | 5 | 15 | View |
| Vehicle Twice Daily | Vehicle administered to affected areas twice daily Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days | None | None | 0 | 15 | 6 | 15 | View |
| Desoximetasone 0.25% Twice Daily | Desoximetasone topical spray 0.25% administered twice daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days | None | None | 0 | 29 | 4 | 29 | View |
| Desoximetasone 0.05% Once Daily | Desoximetasone topical spray 0.05% administered once daily to affected area Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days | None | None | 0 | 30 | 6 | 30 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Application Site Dryness | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0) | View |
| Application Site Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0) | View |
| Application Site Irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0) | View |
| Application Site Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 10.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0) | View |
| Excoriation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0) | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0) | View |
| Furuncle | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0) | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 10.0) | View |
| Tooth Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0) | View |
| Tooth Injury | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0) | View |
| Tooth Ache | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 10.0) | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0) | View |