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 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
NCT ID:
NCT00694369
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
Study:
NCT00694369
Study Brief:
A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | Placebo orally once daily | None | None | 0 | 46 | 12 | 46 | View |
| Etoricoxib 90 mg | Etoricoxib 90 mg orally once daily | None | None | 0 | 191 | 54 | 191 | View |
| Etoricoxib 120 mg | Etoricoxib 120 mg orally once daily | None | None | 0 | 97 | 28 | 97 | View |
| Ibuprofen 2400 mg | Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally | None | None | 0 | 192 | 57 | 192 | View |
| Acetaminophen 2400 mg/Codeine 240 mg | Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally | None | None | 0 | 62 | 35 | 62 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 11.1 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.1 | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 11.1 | View |
| Blepharospasm | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 11.1 | View |
| Dry Eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 11.1 | View |
| Vision Blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 11.1 | View |
| Visual Impairment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 11.1 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Aphthous stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Gingival pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Gingivitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Sensitivity of teeth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Stomach discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Facial pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Feeling cold | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Feeling hot | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Thirst | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.1 | View |
| Alveolar osteitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Fungal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Incision site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Oral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Vulvovaginal mycotic infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.1 | View |
| Accidental Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Incision site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Post procedural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Procedural site reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.1 | View |
| Heart rate increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 11.1 | View |
| Appetite disorder | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 11.1 | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Neck Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Pain in jaw | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Sinus headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.1 | View |
| Affect lability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Nightmare | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 11.1 | View |
| Chromaturia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.1 | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.1 | View |
| Erectile dysfunction | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 11.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Dry Throat | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Pharyngeal oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Sinus congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Throat irritation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |
| Dry Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |
| Ecchymosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |
| Pruritis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |
| Rash generalized | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |
| Rash pruritic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.1 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |
| Pallor | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.1 | View |