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; Cohort 1; RJX | Participants in Part 1; Cohort 1 received a single 0.024 mL/kg dose of RJX on Day 1. | 0 | None | 0 | 6 | 1 | 6 | View |
| Part 1; Cohort 2; RJX | Participants in Part 1; Cohort 2 received a single 0.076 mL/kg dose of RJX on Day 1. | 0 | None | 0 | 6 | 2 | 6 | View |
| Part 1; Cohort 3; RJX | Participants in Part 1; Cohort 3 received a single 0.240 mL/kg dose of RJX on Day 1. | 0 | None | 0 | 6 | 0 | 6 | View |
| Part 1; Cohort 4; RJX | Participants in Part 1; Cohort 4 received a single 0.500 mL/kg dose of RJX on Day 1. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part 1; Cohort 5; RJX | Participants in Part 1; Cohort 5 received a single 0.759 mL/kg dose of RJX on Day 1. | 0 | None | 0 | 6 | 2 | 6 | View |
| Part 1; Cohort 6; RJX | Participants in Part 1; Cohort 6 receive a single dose of 0.500 mL/kg RJX on Day 1. Cohort 6 subjects comprised a cohort of healthy volunteers aged 50-70 inclusive. | 0 | None | 0 | 9 | 0 | 9 | View |
| Part 2; Placebo | Participants in Part 2 received a saline placebo every day for 7 days. | 0 | None | 0 | 6 | 1 | 6 | View |
| Part 2; Cohort 1; RJX | Participants in Part 2; Cohort 1 received a dose of 0.240 mL/kg RJX every day for 7 days. | 0 | None | 0 | 6 | 1 | 6 | View |
| Part 2; Cohort 2; RJX or Placebo | Participants in Part 2; Cohort 2 received a dose of 0.500 mL/kg RJX every day for 7 days. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part 2; Cohort 3; RJX or Placebo | Participants in Part 2; Cohort 3 received a dose of 0.759 mL/kg RJX every day for 7 days. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part 1; Placebo | Participants in Part 1 received a single saline placebo on Day 1. | 0 | None | 0 | 13 | 2 | 13 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Clonus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Pain In Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Musculoskeletal Chest Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Infusion site discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Infusion Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Infusion Site Reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Delayed Sleep Phase | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Blood Pressure Systolic Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| C-reactive Protein Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |