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 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
NCT ID:
NCT03213405
Description:
Participants received a single dose of the vaccine, administered intradermally in the deltoid area following the standard national protocol for BCG vaccination used in Chile, and were observed during the following 3 hours. Participants were then evaluated at 1-3, 7, 14, 30, 60, 120, and 180 days post-vaccination. Follow up phone calls were performed at 4, 21, 45, 90, and 150 dpv.
Frequency Threshold:
0
Time Frame:
Up to 180 days post-vaccination (A total of 11 months and 6 days for the whole study).
Study:
NCT03213405
Study Brief:
A Study to Assess Safety, Tolerability and Immunogenicity of the Live Attenuated hRSV Vaccine rBCG-N-hRSV
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Conventional BCG Full Dose | Participants will receive one full dose of the Conventional BCG vaccine administered as an intradermal injection at study entry. Conventional BCG full dose: 2x10\^5 colony forming units (CFU) of conventional BCG will be administered as an intradermal injection. | 0 | None | 1 | 6 | 6 | 6 | View |
| rBCG-N-hRSV 1/100 Dose | Participants will receive one 1/100 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry. rBCG-N-hRSV 1/100: 5x10\^3 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection. | 0 | None | 0 | 6 | 6 | 6 | View |
| rBCG-N-hRSV 1/10 Dose | Participants will receive one 1/10 dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry. rBCG-N-hRSV 1/10: 5x10\^4 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection. | 0 | None | 0 | 6 | 6 | 6 | View |
| rBCG-N-hRSV Full Dose | Participants will receive one full dose of the rBCG-N-hRSV vaccine administered as an intradermal injection at study entry. rBCG-N-hRSV full dose: 1x10\^5 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection. | 0 | None | 0 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Increase in CPK | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Low Hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Increased CPK | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Leukocyturia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Increased aspartate aminotransferase | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Pustule at the inoculation site | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Scab at the inoculation site | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sensitivity at the inoculation site | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Erythema at the inoculation site | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Induration at the inoculation site | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |