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 @ 12:00 PM
Ignite Modification Date:
2025-12-25 @ 11:57 AM
NCT ID:
NCT00565461
Description:
None
Frequency Threshold:
2
Time Frame:
None
Study:
NCT00565461
Study Brief:
LT Vaccine Patch Self-Administration Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Self Administered (Non-clinic) | 40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh. heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh | None | None | 0 | 40 | 40 | 40 | View |
| Clinician Administered (Deltoid) | 40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh | None | None | 1 | 40 | 40 | 40 | View |
| Clinician Administered (Thigh) | 40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician. heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh | None | None | 3 | 40 | 40 | 40 | View |
| Self Administered (In-clinic) | 40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh. heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh | None | None | 0 | 40 | 40 | 40 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute myocardial infarction | None | Cardiac disorders | None | View |
| Brugada syndrome | None | Cardiac disorders | None | View |
| Colitis | None | Gastrointestinal disorders | None | View |
| Intervertebral disc protrusion | None | Musculoskeletal and connective tissue disorders | None | View |
| Menorrhagia | None | Reproductive system and breast disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | None | Gastrointestinal disorders | None | View |
| Influenza | None | Infections and infestations | None | View |
| Upper respiratory tract infection | None | Infections and infestations | None | View |
| Application site erythema | None | Injury, poisoning and procedural complications | None | View |
| Application site pain | None | Injury, poisoning and procedural complications | None | View |
| Application site rash | None | Injury, poisoning and procedural complications | None | View |
| Protein urine present | None | Investigations | None | View |
| Headache | None | Nervous system disorders | None | View |
| Pharyngolaryngeal pain | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Malaise | None | General disorders | None | View |
| Nasopharyngitis | None | Infections and infestations | None | View |
| Sinusitis | None | Infections and infestations | None | View |
| Application site discoloration | None | Injury, poisoning and procedural complications | None | View |
| Application site edema | None | Injury, poisoning and procedural complications | None | View |
| Application site excoriation | None | Injury, poisoning and procedural complications | None | View |
| Application site pruritus | None | Injury, poisoning and procedural complications | None | View |
| Application site scab | None | Injury, poisoning and procedural complications | None | View |
| Blood glucose increased | None | Investigations | None | View |
| Red blood cells in urine | None | Investigations | None | View |
| Hematuria | None | Renal and urinary disorders | None | View |
| Proteinuria | None | Renal and urinary disorders | None | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | None | View |