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 @ 7:37 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
NCT ID:
NCT02336503
Description:
Adverse event definitions followed clinicaltrials.gov guidance
Frequency Threshold:
0
Time Frame:
Adverse events were assessed following a participant's consent to participate, while receiving approximately one month of investigational treatment (Baseline Visit and Visit Day 29), and subsequently two weeks following completion of investigational treatment (Day 42).
Study:
NCT02336503
Study Brief:
A Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| BBI-4000 Gel, 5% | BBI-4000 Gel, 5%, administered to each axillae nightly | 0 | None | 0 | 47 | 8 | 47 | View |
| BBI-4000 Gel, 10% | BBI-4000 Gel, 10%, administered to each axillae nightly | 0 | None | 0 | 48 | 12 | 48 | View |
| Vehicle | BBI-4000 Gel, 0% (Placebo) | 0 | None | 0 | 46 | 6 | 46 | View |
| BBI-4000 Gel, 15% | BBI-4000 Gel, 15%, administered to each axillae nightly | 0 | None | 0 | 48 | 14 | 48 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dry Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.1) | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Eructation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Lip Dry | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Tooth Ache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Application Site Dermatitis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Application Site Dryness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Application Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Application Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Application Site Pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Application Site Rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Application Site Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Application Site Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Bacterial Vaginosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Dermatitis Infected | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Herpes Simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Joint Dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| Tooth Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| Crystal Urine Present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| Muscle Spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.1) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.1) | View |
| Urinary Hesitation | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.1) | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Nasal Dryness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| Sinus Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| Dermatitis Contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.1) | View |