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 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
NCT ID:
NCT02536833
Description:
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
Frequency Threshold:
5
Time Frame:
Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Study:
NCT02536833
Study Brief:
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 0.03 mg SM04690 | Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension | 0 | None | 5 | 111 | 25 | 111 | View |
| 0.07 mg SM04690 | Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension | 0 | None | 4 | 114 | 23 | 114 | View |
| Other | Single intra-articular injection of an unidentified dose of SM04690 or Placebo due to incorrectly performed dilution or documentation by a pharmacist. | 0 | None | 1 | 15 | 11 | 15 | View |
| 0.23 mg SM04690 | Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension | 0 | None | 4 | 104 | 19 | 104 | View |
| Placebo | Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline | 0 | None | 3 | 108 | 18 | 108 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Aortic valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Atrial septal defect | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (18.0) | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Patella fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | View |
| Gallbladder adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | View |
| Myelitis transverse | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.0) | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.0) | View |
| Uterine prolapse | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Aortic aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Arteriosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (18.0) | View |
| Visual acuity reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.0) | View |
| Hiatus hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Large intestine polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Oesophageal motility disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Meniscus injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Joint crepitation | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Patellofemoral pain syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Decreased vibratory sense | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Varicose vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |