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 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
NCT ID:
NCT02751320
Description:
None
Frequency Threshold:
1
Time Frame:
None
Study:
NCT02751320
Study Brief:
Efficacy of Three Toothpastes Using an in Situ Caries Model
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Reference Product 2 | Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s. | 0 | None | 0 | 27 | 4 | 27 | View |
| Reference Product 3 | Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 1150ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s. | 0 | None | 0 | 28 | 8 | 28 | View |
| Test Product 3 | Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F, 0.3% ZnCl2) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s | 0 | None | 0 | 28 | 10 | 28 | View |
| Reference Product 1 | Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0 ppm fluoride) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s. | 0 | None | 0 | 29 | 7 | 29 | View |
| Test Product 1 | Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.425 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s. | 0 | None | 1 | 28 | 9 | 28 | View |
| Test Product 2 | Participants brushed their natural teeth with a pre-wetted toothbrush and their assigned dentifrice (containing 0.85 % phytate, 1150 ppm F) for one timed minute, ensuring the enamel specimens retained within their mouths were not directly brushed. Participants then rinsed their mouths with 15ml of tap water for approximately 10s. | 0 | None | 0 | 28 | 9 | 28 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| INVASIVE DUCTAL BREAST CARCINOMA | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lip injury | None | Injury, poisoning and procedural complications | None | View |
| Muscle strain | None | Injury, poisoning and procedural complications | None | View |
| Traumatic ulcer | None | Injury, poisoning and procedural complications | None | View |
| Headache | None | Nervous system disorders | None | View |
| Migraine | None | Nervous system disorders | None | View |
| Device Failure | None | Product Issues | None | View |
| Injury Associated With Device | None | General disorders | None | View |
| Seasonal Allergy | None | Immune system disorders | None | View |
| Angular cheilitis | None | Infections and infestations | None | View |
| Nasopharyngitis | None | Infections and infestations | None | View |
| Oral herpes | None | Infections and infestations | None | View |
| Pneumonia | None | Infections and infestations | None | View |
| Urinary tract infection | None | Infections and infestations | None | View |
| Glucose Tolerance Impaired | None | Metabolism and nutrition disorders | None | View |
| Musculoskeletal Pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Allergic sinusitis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Asthma | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pharyngeal erythema | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Skin cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Lip dry | None | Gastrointestinal disorders | None | View |
| Noninfective gingivitis | None | Gastrointestinal disorders | None | View |
| Tongue coated | None | Gastrointestinal disorders | None | View |
| Tongue oedema | None | Gastrointestinal disorders | None | View |
| Thermal burn | None | Injury, poisoning and procedural complications | None | View |
| Laceration | None | Injury, poisoning and procedural complications | None | View |
| GINGIVAL ERYTHEMA | None | Gastrointestinal disorders | None | View |
| Mouth ulceration | None | Gastrointestinal disorders | None | View |
| Dry mouth | None | Gastrointestinal disorders | None | View |
| Gingival ulceration | None | Gastrointestinal disorders | None | View |
| Oral mucosal erythema | None | Gastrointestinal disorders | None | View |
| Toothache | None | Gastrointestinal disorders | None | View |
| Gastrooesophageal reflux disease | None | Gastrointestinal disorders | None | View |
| Gingival oedema | None | Gastrointestinal disorders | None | View |
| Gingival pain | None | Gastrointestinal disorders | None | View |
| Gingival swelling | None | Gastrointestinal disorders | None | View |
| Leukoplakia oral | None | Gastrointestinal disorders | None | View |