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 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
NCT ID:
NCT05485805
Description:
None
Frequency Threshold:
0
Time Frame:
All AEs and SAEs were collected from the signing of the ICF until last contact (follow-up visit at 2-5 days after discharge), an average of 5 days.
Study:
NCT05485805
Study Brief:
A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Naproxen Sodium/ Caffeine 220/65 mg | Participants received one tablet of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg and one tablet of placebo. | 0 | None | 0 | 147 | 19 | 147 | View |
| Naproxen Sodium/Caffeine 2x220/65 mg | Participants received two tablets of the fixed dose combination Naproxen sodium/Caffeine 220/65 mg. | 0 | None | 0 | 148 | 11 | 148 | View |
| Placebo | Participants received two tablets of placebo. | 0 | None | 0 | 49 | 4 | 49 | View |
| Caffeine 100 mg | Participants received one tablet Caffeine 100 mg one tablet of placebo. | 0 | None | 0 | 50 | 3 | 50 | View |
| Naproxen Sodium 220 mg | Participants received one tablet of Naproxen sodium 220 mg and one tablet of placebo. | 0 | None | 0 | 147 | 23 | 147 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Alveolar osteitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Deafness | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 25.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Candida infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Post procedural infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Wound haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |