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 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:38 AM
NCT ID:
NCT04174560
Description:
None
Frequency Threshold:
5
Time Frame:
Day 1 through Day 180
Study:
NCT04174560
Study Brief:
Phase I Norovirus Challenge Model
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 3.5x10^5 Copies - Secretor Positive | Single dose (3.5x10\^5 copies) of norovirus GII.4 CIN-3 Batch No.: 01-16C3 inoculum (with 60 mL of a 2% sodium bicarbonate before and after inoculum administration) given orally. Participants tested positive for the secretor gene. | 0 | None | 0 | 18 | 15 | 18 | View |
| Secretor Negative | Single dose (3.5x10\^3, 3.5x10\^4 or 3.5x10\^5 copies) of norovirus GII.4 CIN-3 Batch No.: 01-16C3 inoculum (with 60 mL of a 2% sodium bicarbonate before and after inoculum administration) given orally. Participants lacked the secretor gene. | 0 | None | 0 | 3 | 3 | 3 | View |
| 3.5x10^4 Copies - Secretor Positive | Single dose (3.5x10\^4 copies) of norovirus GII.4 CIN-3 Batch No.: 01-16C3 inoculum (with 60 mL of a 2% sodium bicarbonate before and after inoculum administration) given orally. Participants tested positive for the secretor gene. | 0 | None | 0 | 12 | 11 | 12 | View |
| 3.5x10^3 Copies - Secretor Positive | Single dose (3.5x10\^3 copies) of norovirus GII.4 CIN-3 Batch No.: 01-16C3 inoculum (with 60 mL of a 2% sodium bicarbonate before and after inoculum administration) given orally. Participants tested positive for the secretor gene. | 0 | None | 0 | 15 | 11 | 15 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Abdominal Pain Lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Gastrointestinal Sounds Abnormal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Tooth Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Blood Pressure Diastolic Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood Pressure Systolic Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Neck Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Bacterial Vaginosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| Blood Pressure Diastolic Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Blood Pressure Systolic Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| Abdominal Distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |