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 @ 4:09 PM
Ignite Modification Date: 2025-12-25 @ 2:09 PM
NCT ID: NCT04898166
Description: Our participants are hospitalized COVID-19 patients. Their adverse events are categorised as on oxygen mask/bag,nasal cannula, ventilator or death. Other non serious adverse events are zero because all of our participants were having covid19 so they faced it's symptom and no any other adverse event separately
Frequency Threshold: 0
Time Frame: From date of randomization until the date of clinical improvement (discharge, from ventilator to mask/nasal cannula) or worsening of condition(from mask/bag to ventilator) or death from any cause, assessed up to 4 months
Study: NCT04898166
Study Brief: Association of Androgenetic Alopecia and Severity of Coronavirus Disease 2019 (COVID-19).
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
300 Participants Diagnosed Case of Hospitalized COVID-19 With or Without Androgenetic Alopecia. 300 Participants diagnosed case of hospitalized COVID-19. 220 males and 80 females. Presence or absence of androgenetic alopecia be noted in males and females. Severity of androgeneic throught be noted throught Hamilton norwood score and ludwig score, respectively. Severity of COVID-19 and outcome be noted as patient on mask/bag, nasal cannula, ventilator or death. 87 None 300 300 0 300 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
87 male and female participants death SYSTEMATIC_ASSESSMENT Infections and infestations None View
Male and female participants on ventilator SYSTEMATIC_ASSESSMENT Infections and infestations None View
Male and female participants on oxygen mask/bag SYSTEMATIC_ASSESSMENT Infections and infestations None View
Male and female participants on nasal cannula SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):