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 @ 9:55 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
NCT ID:
NCT00225732
Description:
None
Frequency Threshold:
5
Time Frame:
14 Days
Study:
NCT00225732
Study Brief:
Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients
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 | The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia. | None | None | 6 | 153 | 149 | 153 | View |
| 800 mg Intravenous Ibuprofen | The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia. | None | None | 12 | 166 | 150 | 166 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.1 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Peritoneal Hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.1) | View |
| Abdominal Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Peritoneal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Wound drainage | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (10.1) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.1) | View |
| Wound Dihisence | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| Vaginal hemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.1) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.1) | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.1) | View |
| Subdural hematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.1) | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Body temperature increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (10.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.1) | View |