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 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
NCT ID:
NCT04752033
Description:
None
Frequency Threshold:
0
Time Frame:
12 and 24 hours
Study:
NCT04752033
Study Brief:
Intrathecal Opioids for Colorectal Resection
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Hydromorphone 200 mcg | Subjected to sequential up and down dose titration using biased coin method in parallel with the morphine arm Hydromorphone: Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a hydromorphone dose that is within the range of doses currently utilized clinically and no participant will receive placebo only. | 0 | None | 0 | 12 | 9 | 12 | View |
| Morphine 100 mcg | Subjected to sequential up and down dose titration using biased coin method in parallel with the hydromorphone arm Morphine: Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a morphine dose that is within the range of doses currently utilized clinically and no participant will receive placebo only. | 0 | None | 0 | 5 | 5 | 5 | View |
| Morphine 150 mcg | Subjected to sequential up and down dose titration using biased coin method in parallel with the hydromorphone arm Morphine: Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a morphine dose that is within the range of doses currently utilized clinically and no participant will receive placebo only. | 0 | None | 0 | 4 | 3 | 4 | View |
| Morphine 200 mcg | Subjected to sequential up and down dose titration using biased coin method in parallel with the hydromorphone arm Morphine: Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a morphine dose that is within the range of doses currently utilized clinically and no participant will receive placebo only. | 0 | None | 0 | 4 | 3 | 4 | View |
| Morphine 350 mcg | Subjected to sequential up and down dose titration using biased coin method in parallel with the hydromorphone arm Morphine: Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a morphine dose that is within the range of doses currently utilized clinically and no participant will receive placebo only. | 0 | None | 0 | 4 | 4 | 4 | View |
| Hydromorphone 50 mcg | Subjected to sequential up and down dose titration using biased coin method in parallel with the morphine arm Hydromorphone: Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a hydromorphone dose that is within the range of doses currently utilized clinically and no participant will receive placebo only. | 0 | None | 0 | 6 | 3 | 6 | View |
| Hydromorphone 100 mcg | Subjected to sequential up and down dose titration using biased coin method in parallel with the morphine arm Hydromorphone: Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a hydromorphone dose that is within the range of doses currently utilized clinically and no participant will receive placebo only. | 0 | None | 0 | 6 | 6 | 6 | View |
| Morphine 300 mcg | Subjected to sequential up and down dose titration using biased coin method in parallel with the hydromorphone arm Morphine: Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a morphine dose that is within the range of doses currently utilized clinically and no participant will receive placebo only. | 0 | None | 0 | 1 | 1 | 1 | View |
| Morphine 50 mcg | Subjected to sequential up and down dose titration using biased coin method in parallel with the hydromorphone arm Morphine: Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a morphine dose that is within the range of doses currently utilized clinically and no participant will receive placebo only. | 0 | None | 0 | 2 | 2 | 2 | View |
| Morphine 250 mcg | Subjected to sequential up and down dose titration using biased coin method in parallel with the hydromorphone arm Morphine: Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a morphine dose that is within the range of doses currently utilized clinically and no participant will receive placebo only. | 0 | None | 0 | 4 | 4 | 4 | View |
| Morphine 400 mcg | Subjected to sequential up and down dose titration using biased coin method in parallel with the hydromorphone arm Morphine: Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a morphine dose that is within the range of doses currently utilized clinically and no participant will receive placebo only. | 0 | None | 0 | 16 | 16 | 16 | View |
| Hydromorphone 75 mcg | Subjected to sequential up and down dose titration using biased coin method in parallel with the morphine arm Hydromorphone: Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a hydromorphone dose that is within the range of doses currently utilized clinically and no participant will receive placebo only. | 0 | None | 0 | 10 | 6 | 10 | View |
| Hydromorphone 125 mcg | Subjected to sequential up and down dose titration using biased coin method in parallel with the morphine arm Hydromorphone: Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a hydromorphone dose that is within the range of doses currently utilized clinically and no participant will receive placebo only. | 0 | None | 0 | 2 | 2 | 2 | View |
| Hydromorphone 150 mcg | Subjected to sequential up and down dose titration using biased coin method in parallel with the morphine arm Hydromorphone: Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a hydromorphone dose that is within the range of doses currently utilized clinically and no participant will receive placebo only. | 0 | None | 0 | 1 | 1 | 1 | View |
| Hydromorphone 175 mcg | Subjected to sequential up and down dose titration using biased coin method in parallel with the morphine arm Hydromorphone: Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a hydromorphone dose that is within the range of doses currently utilized clinically and no participant will receive placebo only. | 0 | None | 0 | 3 | 3 | 3 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea and Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea and Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea and Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea and Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea and Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea and Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |