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 @ 5:55 PM
Ignite Modification Date:
2025-12-25 @ 3:19 PM
NCT ID:
NCT03869268
Description:
Adverse events not reported as they are expected as a normal response to endotoxin:
Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
Frequency Threshold:
0
Time Frame:
Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Study:
NCT03869268
Study Brief:
The Impact of Aspirin Dose Modification on the Innate Immune Response - Will Lower Dose Aspirin Therapy Reduce the Response to Endotoxin
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| No Drug | Patients will be randomised to receive no drug for the first medication period (10 days) followed by endotoxin challenge | 0 | None | 0 | 17 | 3 | 17 | View |
| No Drug Plus Ticagrelor 180mg | Participants will be randomised to receive no drug, then a loading dose of ticagrelor 180 mg on the last day of the first medication period (10-14 days) followed by endotoxin challenge | 0 | None | 0 | 16 | 3 | 16 | View |
| Aspirin 20mg BD | Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10 days) followed by endotoxin challenge | 0 | None | 0 | 17 | 5 | 17 | View |
| Aspirin 20mg BD & Ticagrelor 180mg | Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10-14 days) plus a loading dose of ticagrelor 180 mg on the last day of the period followed by endotoxin challenge. | 0 | None | 0 | 17 | 4 | 17 | View |
| Aspirin 75mg OD & Ticagrelor 180mg | Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days),with a loading dose of ticagrelor 180 mg on the last day of the period followed by endotoxin challenge | 0 | None | 0 | 14 | 5 | 14 | View |
| Aspirin 300mg OD & Ticagrelor 180mg | Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10-14 days) plus a loading dose of ticagrelor 180 mg on the last day of the period followed by endotoxin challenge | 0 | None | 0 | 15 | 2 | 15 | View |
| Aspirin 75mg OD | Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days). followed by endotoxin challenge | 0 | None | 0 | 16 | 4 | 16 | View |
| Aspirin 300mg OD | Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10 days) followed by endotoxin challenge | 0 | None | 0 | 15 | 5 | 15 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Bruise | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| epigastric pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| hypokalaemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Bleeding | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| pinpoint pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| cold sores | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Covid-19 infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| foot injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| excess phleghm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| vasovagal episode | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |