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 @ 2:00 PM
Ignite Modification Date: 2025-12-25 @ 12:46 PM
NCT ID: NCT01372995
Description: As critically ill study patients are known to have a high morbidity and mortality rate, no adverse events specifically due to the study drug were expected. The clinical course of every participant was monitored to record any unexpected adverse events and all serious adverse events (SAEs). SAEs were defined as death, rehospitalization or reoperation within 30 days, cardiopulmonary arrest, pulmonary aspiration during feeding tube administration, new cancer diagnosis, and congenital anomalies.
Frequency Threshold: 0
Time Frame: Data regarding serious adverse events and non-serious adverse events were collected from the start of treatment until 30 days after study drug discontinuation (35 days in total). Ongoing events were monitored until resolution.
Study: NCT01372995
Study Brief: Vitamin D in Ventilated ICU Patients
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 Participants randomized to receive an inactive substance administered enterally for 5 days None None 1 10 0 10 View
250,000 IU of Vitamin D3 Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally. None None 1 9 0 9 View
500,000 IU of Vitamin D3 Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally. None None 2 11 0 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Re-hospitalization NON_SYSTEMATIC_ASSESSMENT General disorders None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cardiopulmonary arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):