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 @ 10:37 PM
Ignite Modification Date: 2025-12-25 @ 8:09 PM
NCT ID: NCT01605435
Description: None
Frequency Threshold: 0
Time Frame: Recorded from study screen through 30 days after the final study visit. Assessed systematically during study visits at time 0, 15, 30, 45, 60, 90 120, and 150 minutes after dosing and 1 day after all study visits by telephone call to subject.
Study: NCT01605435
Study Brief: Ghrelin Dose Finding In Frail Elderly
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Visit 1 for all five subjects placebo injected s.c. at time 0 None None 0 5 2 5 View
2mcg/kg Visit 2 for the first two subjects 2mcg/kg ghrelin injected s.c at time 0 None None 0 2 0 2 View
5mcg/kg Visit 3 for the first two subjects Visit 2 for the last three subjects 5mcg/kg ghrelin injected s.c. at time 0 None None 0 5 1 5 View
7.5mcg/kg Visit 3 for the last three subjects 7.5mcg/kg ghrelin injected at time 0 None None 0 3 3 3 View
10mcg/kg Visit 4 for all five subjects None None 0 5 1 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
bristley feeling in chest SYSTEMATIC_ASSESSMENT General disorders None View
burping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
awareness of sternotomy incision SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
warmth SYSTEMATIC_ASSESSMENT General disorders None View
euphoria SYSTEMATIC_ASSESSMENT General disorders None View