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:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT01510912
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01510912
Study Brief:
Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Diclofenac 35 mg Capsules | Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator. | None | None | 42 | 601 | 191 | 601 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina pectoris | None | Cardiac disorders | None | View |
| Angina unstable | None | Cardiac disorders | None | View |
| Atrial fibrillation | None | Cardiac disorders | None | View |
| Coronary artery disease | None | Cardiac disorders | None | View |
| Coronary artery stenosis | None | Cardiac disorders | None | View |
| Myocardial infarction | None | Cardiac disorders | None | View |
| Hyperparathyroidism | None | Endocrine disorders | None | View |
| Abdominal hernia | None | Gastrointestinal disorders | None | View |
| Colitis | None | Gastrointestinal disorders | None | View |
| Diverticular perforation | None | Gastrointestinal disorders | None | View |
| Gastrointestinal pain | None | Gastrointestinal disorders | None | View |
| Intestinal strangulation | None | Gastrointestinal disorders | None | View |
| Pancreatitis | None | Cardiac disorders | None | View |
| Small intestinal obstruction | None | Gastrointestinal disorders | None | View |
| Chest pain | None | General disorders | None | View |
| Bile duct stone | None | Hepatobiliary disorders | None | View |
| Diverticulitis | None | Infections and infestations | None | View |
| Lobar pneumonia | None | Infections and infestations | None | View |
| Pneumonia | None | Infections and infestations | None | View |
| Pneumonia bacterial | None | Infections and infestations | None | View |
| Post procedural infection | None | Infections and infestations | None | View |
| Septic shock | None | Infections and infestations | None | View |
| Urinary tract infection | None | Infections and infestations | None | View |
| Dural tear | None | Injury, poisoning and procedural complications | None | View |
| Seroma | None | Injury, poisoning and procedural complications | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Intervertebral disc protrusion | None | Musculoskeletal and connective tissue disorders | None | View |
| Lumbar spinal stenosis | None | Musculoskeletal and connective tissue disorders | None | View |
| Muscle spasms | None | Musculoskeletal and connective tissue disorders | None | View |
| Osteoarthritis | None | Musculoskeletal and connective tissue disorders | None | View |
| Colon cancer metastatic | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Prostate cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Amyotrophic lateral sclerosis | None | Nervous system disorders | None | View |
| Carotid artery stenosis | None | Nervous system disorders | None | View |
| Anxiety | None | Psychiatric disorders | None | View |
| Depression | None | Psychiatric disorders | None | View |
| Major depression | None | Psychiatric disorders | None | View |
| Chronic obstructive pulmonary disease | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary embolism | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Cellulitis | None | Skin and subcutaneous tissue disorders | None | View |
| Finger amputation | None | Surgical and medical procedures | None | View |
| Carotid artery stenosis | None | Vascular disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | None | Nervous system disorders | None | View |
| Upper respiratory tract infection | None | Infections and infestations | None | View |
| Urinary tract infection | None | Infections and infestations | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Nasopharyngitis | None | Infections and infestations | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |