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 @ 7:10 PM
Ignite Modification Date:
2025-12-25 @ 4:44 PM
NCT ID:
NCT03191903
Description:
The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.
Frequency Threshold:
0
Time Frame:
All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population).
Study:
NCT03191903
Study Brief:
Study of Cingal™ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Triamcinolone Hexacetonide (TH) | Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection. | 0 | None | 0 | 74 | 20 | 74 | View |
| Cingal | Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection. | 0 | None | 7 | 251 | 101 | 251 | View |
| Monovisc | Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection. | 0 | None | 0 | 251 | 101 | 251 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Fracture of lateral malleolus, closed | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Delirium tremens | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Foot operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 20.0 | View |
| Inner ear inflammation | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.0 | View |
| Head Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Varicose Vein | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.0 | View |
| Glucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.0 | View |
| Lens dislocation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.0 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Abdominal Pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Food Poisoning | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Gastrointestinal Inflammation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Irritable bowel syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Injection site warmth | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Seasonal Allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 20.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Lyme disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Forearm fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Meniscus injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Blood cholesterol increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Blood pressure decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Culture urine positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Joint effusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Joint range of motion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Joint range of motion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Joint stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Plantar fascitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Spinal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Tenosynovitis stenosans | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Trigger finger | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Cervical radiculopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Delirium tremens | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Benign Prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Ovulation pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.0 | View |
| Sinus pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Upper respiratory tract inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Granuloma skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Cataract operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 20.0 | View |
| Foot operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 20.0 | View |
| Hypertention | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Varicose vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Palpitation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Ear Pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.0 | View |
| Inner ear inflammation | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.0 | View |
| Injection site oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Joint warmth | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Muscle tightness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Mental disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Neurosis | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Cystitis noninfective | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.0 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |