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 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
NCT ID:
NCT04867434
Description:
No difference from clinicaltrials.gov
Frequency Threshold:
0
Time Frame:
3 months
Study:
NCT04867434
Study Brief:
Efficacy and Safety of RZL-012 on Submental Fat Reduction
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| RZL-012 50mg/ml | Subjects treated with RZL-012 will undergo a single treatment session with 32±4 injections. The maximal number of injections will be 36 with maximal doses 270 mg for the high doses. Each injection point will be dosed with 7.5 mg for the high dose in a volume of 0.15 mL/injection site. RZL-012: small synthetic molecule for submental fat reduction | 0 | None | 0 | 50 | 49 | 50 | View |
| RZL-012 34mg/ml | Subjects treated with RZL-012 will undergo a single treatment session with 32±4 injections. The maximal number of injections will be 36 with maximal doses of 183.6 mg for the low dose. Each injection point will be dosed with 5.1 mg RZL-012 for the low dose in a volume of 0.15 mL/injection site. RZL-012: small synthetic molecule for submental fat reduction | 0 | None | 0 | 53 | 51 | 53 | View |
| Placebo | Placebo (vehicle) subjects will be injected with a 0.15 mL vehicle per each injection site. The maximal injection volume for all groups will be up to 5.4 mL. Placebo: Placebo | 0 | None | 0 | 48 | 48 | 48 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site edema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Injection site Bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site hemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site hypoesthesia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site mass | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site paraesthesia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Localized edema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site hypersensitivity | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| injection site movement impairment | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| facial paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site dermatitis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Tenderness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site nodule | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site warmth | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Burning sensation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Facial nerve disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |