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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part 1 Schedule A: TA 1 (Low TDL HYQVIA) | Participants received a subcutaneous (SC) infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner. | 0 | None | 0 | 8 | 8 | 8 | View |
| Part 2 Schedule A: TA 4 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner. | 0 | None | 0 | 8 | 8 | 8 | View |
| Part 1 Schedule B: TA 2 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. | 0 | None | 0 | 8 | 8 | 8 | View |
| Part 2 Schedule B: TA 5 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner. | 0 | None | 0 | 9 | 9 | 9 | View |
| Part 1 Schedule C: TA 3 (Low TDL HYQVIA) | Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner. | 0 | None | 0 | 8 | 8 | 8 | View |
| Part 2 Schedule C: TA 6 (High TDL HYQVIA) | Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner, | 0 | None | 0 | 10 | 10 | 10 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood pressure systolic decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 24.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 24.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 24.0 | View |
| Infusion site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Infusion site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Infusion site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Infusion site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Infusion site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |