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 @ 5:28 PM
Ignite Modification Date: 2025-12-25 @ 3:02 PM
NCT ID: NCT05413668
Description: Adverse events were defined as "Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research."
Frequency Threshold: 0
Time Frame: Adverse events were collected from signing of consent to last study visit - approximately 7 days.
Study: NCT05413668
Study Brief: First in Human Study of RVP-001, a New Manganese Based MRI Contrast Agent
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RVP-001: 2 mg Mn/kg 6 subjects received RVP-001 in a single dose of 2 mg Mn/kg administered via automated injection pump 0 None 0 6 1 6 View
RVP-001: 4 mg Mn/kg 6 subjects received RVP-001 in a single dose of 4 mg Mn/kg administered via automated injection pump 0 None 0 6 2 6 View
RVP-001: 7 mg Mn/kg 6 subjects received RVP-001 in a single dose of 7 mg Mn/kg administered via automated injection pump 0 None 0 6 2 6 View
RVP-001: 12 mg Mn/kg 6 subjects received RVP-001 in a single dose of 12 mg Mn/kg administered via automated injection pump 0 None 0 6 0 6 View
Placebo Group 8 subjects received placebo (saline) via automated injection pump 0 None 0 8 1 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View