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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT02814708
Description:
None
Frequency Threshold:
5
Time Frame:
27 months
Study:
NCT02814708
Study Brief:
Clinical Trial of the BioMed rTSST-1 Variant Vaccine in Healthy Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dose Group 1 | rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 1 rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer . | 0 | None | 0 | 20 | 13 | 20 | View |
| Dose Group 2 | rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 2 rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer . | 0 | None | 0 | 20 | 16 | 20 | View |
| Dose Group 3 | rTSST-1 Variant Candidate Vaccine 10µg Number of Immunizations: 3 rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer . | 0 | None | 0 | 20 | 14 | 20 | View |
| Dose Group 4 | rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 1 rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer . | 0 | None | 0 | 20 | 17 | 20 | View |
| Dose Group 5 | rTSST-1 Variant Candidate Vaccine 100µg Number of Immunizations: 2 rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer . | 0 | None | 1 | 20 | 16 | 20 | View |
| Dose Group 6 | rTSST-1 Variant Candidate Vaccine 100 µg Number of Immunizations: 3 rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer . | 0 | None | 0 | 20 | 19 | 20 | View |
| Dose Group 7 | Al(OH)3 Adjuvant, 1mg Number of Immunizations: 3 rTSST-1v: Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of \< 20 to \> 40 or a 4-fold increase in TSST-1 binding Ab titer . | 0 | None | 0 | 20 | 14 | 20 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| anaphylactic reaction | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| mild to moderate AE | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nervos system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| General disorders and administration site conditions | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Influenza-like illness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Musculoskeletal and connective tissue disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Gastrointestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Injury, poisoning and procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Skin and subcutaneous tissue disorders | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Respiratory, thoracic and mediastinal disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Reproductive system and breast disorders | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Surgical and medical procedures | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |