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 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
NCT ID:
NCT03320018
Description:
None
Frequency Threshold:
0
Time Frame:
90 days
Study:
NCT03320018
Study Brief:
Neuroprotection in Acute Ischemic Stroke
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Hydrogen/Minocycline | Hydrogen will be infused into aqueous solution (normal saline or water) at as high a concentration as possible (saturation = 1.6 ppm), and administered intravenously or orally respectively, TID for 3 days. Similarly, Minocycline will be administered either i.v. or p.o. once daily for 5 days. Hydrogen: Hydrogen will be infused into bags of normal saline solution and administered intravenously, or hydrogen generating tablets will be dissolved into water for the patient to drink, as the patient's condition permits. This will be administered TID for 3 days. Minocycline: Minocycline 200 mg will be mixed with normal saline and given by i.v. administration, or provided as capsules for the patient to swallow, q 24 hours for 5 days. Once patients regain the ability to swallow capsules, minocycline will be given orally in capsule form (2 capsules of 100 mg each), administered once daily for the remainder of the 5 day period. | 0 | None | 2 | 6 | 5 | 6 | View |
| Placebo Hydrogen/Placebo Minocycline | Normal saline will be substituted for both Hydrogen and Minocycline for intravenous administration. Water will be substituted for hydrogen when administered p.o., and placebo capsules will be substituted for minocycline. Placebo Hydrogen: Normal saline solution will be administered intravenously, in place of hydrogen solution. Placebo tablets will be dissolved into water for the patient to drink, as the patient's condition permits. This will be administered TID for 3 days. Placebo Minocycline: Normal saline solution or placebo capsule will be administered i.v. or p.o. respectively, in place of minocycline. | 1 | None | 1 | 8 | 5 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| stroke | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| bradycardia and syncope | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| hematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| thrombus | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| vaginal bleeding | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| ecchymotic penis and scrotum | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| pulmonary congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| hypotension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| twitching with anisocoria | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Wound complication | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| skin redness and swelling | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| hematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| petechial hemorrhagic stroke conversion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| increased BUN/creatinine | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| decreased sensation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| inflammation in foot | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| black lesion in foot | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |