Adverse Events Module

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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: 2025-12-24 @ 6:46 PM
Ignite Modification Date: 2025-12-25 @ 4:18 PM
NCT ID: NCT05445557
Description: None
Frequency Threshold: 0
Time Frame: 12 weeks Double blind phase and 12 weeks open label phase
Study: NCT05445557
Study Brief: Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks
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 flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site. RZL-012: small synthetic molecule for submental fat reduction 0 None 0 12 12 12 View
Placebo Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site. Placebo: Placebo 0 None 0 12 12 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
tenderness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Ecchymosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
pain open label phase NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypoesthesia Open Label phase NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pruritus Open Label phase NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Hyperpigmentation open label phase NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin irritation Open Label phase NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
edema Open Label phase NON_SYSTEMATIC_ASSESSMENT General disorders None View
pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypoesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tenderness - Open Label phase NON_SYSTEMATIC_ASSESSMENT General disorders None View
Erythema open label phase NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View