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 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
NCT ID:
NCT02574520
Description:
Systematic and Non-systematic reported TEAEs of \>5% (Safety Population)
Frequency Threshold:
5
Time Frame:
Approximately 0-60 days after surgery (duration of time over which each participant was assessed).
Study:
NCT02574520
Study Brief:
Trial of Extended Release Bupivacaine for Pain Relief After Surgery
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SABER-Bupivacaine (Part 1) | 5 ml once at end of surgery | 0 | None | 1 | 45 | 43 | 45 | View |
| Saline Placebo (Part 1) | 5 ml once at end of surgery | 0 | None | 0 | 47 | 47 | 47 | View |
| SABER-Bupivacaine (Part 2) | 5 ml once at end of surgery | 0 | None | 5 | 148 | 148 | 148 | View |
| Bupivacaine HCL (Part 2) | 0.5%, 15 ml, once at end of surgery | 0 | None | 3 | 148 | 146 | 148 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Bile duct stone | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pancreatitis acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Rectal cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Post procedural bile leak | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Constipation (Solicited) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache (Solicited) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hypoaesthesia (Solicited) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Incision site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Incision site pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Nausea (solicited) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Paraesthesia (Solicited) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Post procedural contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Post procedural discharge | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Pruritus (Solicited) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Somnolence (Solicited) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Vomiting (Solicited) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dizziness (Solicited) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dysgeusia (Solicited) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |