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 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
NCT ID:
NCT00041756
Description:
None
Frequency Threshold:
3
Time Frame:
None
Study:
NCT00041756
Study Brief:
Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
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 Tablet | Placebo tablet dosed BID | None | None | 8 | 77 | 37 | 77 | View |
| 25 mg PG-530742 | 25 mg PG-530742 dosed BID | None | None | 7 | 80 | 41 | 80 | View |
| 50 mg PG-530742 | 50 mg PG-530742 dosed BID | None | None | 12 | 79 | 34 | 79 | View |
| 100 mg PG-530742 | 100 mg PG-530742 dosed BID | None | None | 10 | 80 | 43 | 80 | View |
| 200 mg PG-530742 | 200 mg PG-530742 dosed BID | None | None | 17 | 79 | 44 | 79 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Periarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Localised Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Athralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | COSTART | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | COSTART | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Tibia fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Tendon rupture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Basal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | COSTART | View |
| Vertegrobasilar insufficiency | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | COSTART | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | COSTART | View |
| Renal failure NOS | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | COSTART | View |
| Urethral stricture | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | COSTART | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | COSTART | View |
| Renal colic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | COSTART | View |
| Pneumonia NOS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | COSTART | View |
| Cardiac failure NOS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | COSTART | View |
| Anaemia NOS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | COSTART | View |
| Eosinophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | COSTART | View |
| Atioventricular block NOS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | COSTART | View |
| Angina Unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | COSTART | View |
| Tachycardia NOS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | COSTART | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | COSTART | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | COSTART | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | COSTART | View |
| Cataract unilateral | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | COSTART | View |
| Diverticulitis NOS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | COSTART | View |
| Duodenal erosions | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | COSTART | View |
| Gastric erosions | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | COSTART | View |
| Gastric ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | COSTART | View |
| Appendicitis perforated | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | COSTART | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | COSTART | View |
| Reflux oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | COSTART | View |
| Fibrosis NOS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | COSTART | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | COSTART | View |
| Animal bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | COSTART | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | COSTART | View |
| Humerus fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Biopsy lymph gland abnormal | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | COSTART | View |
| Hypoglycaemia NOS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | COSTART | View |
| Arthritis NOS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Periostitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Toe deformities NOS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Intervertebral disc herniation | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Dupuytren's contracture | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | COSTART | View |
| Fibrositis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | COSTART | View |
| Spondylosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Tendonitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | COSTART | View |
| Breast cancer NOS | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART | View |
| Hepatic cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART | View |
| Metastases to bone | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART | View |
| Ovarian cancer NOS | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | COSTART | View |
| Prostatic hypertrophy | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | COSTART | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | COSTART | View |
| Respiratory distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | COSTART | View |
| Haemorrhage NOS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | COSTART | View |
| Hypertension NOS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | COSTART | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood and lymphatic system disorders (Overall) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Cardiac disorders (Overall) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Ear and labyrinth disorders (Overall) | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (Unspecified) | View |
| Eye disorders (Overall) | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (Unspecified) | View |
| Gastrointestinal disorders (Overall) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| General disorders and administration site conditions (Overall) | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Infections and infestation (Overall) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Injury, poisoning and procedural complications (Overall) | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Investigations (Overall) | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Metabolism and nutrition disorders (Overall) | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Musculoskeletal and connective tissue disorders (Overall) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Neoplasms benign, malignant and unspecified (Overall) | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | View |
| Nervous system disorders (Overall) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Psychiatric disorders | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Renal and urinary disorders | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| Respiratory, thoracic and mediastinal disorders | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Skin and subcutaneous tissue disorders (Overall) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Vascular disorders | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |