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: 2025-12-25 @ 2:07 AM
Ignite Modification Date: 2025-12-26 @ 12:33 AM
NCT ID: NCT04431960
Description: During the entire study period and at each study visit, participants were asked by research staff to report if they experience any adverse events from the intervention.
Frequency Threshold: 0
Time Frame: 6.5 months total. All participants took a calcium citrate caplet daily that includes 400 mg calcium and 500 IU vitamin D beginning 2 weeks before the study and lasting for the duration of the study. After the 2-week equilibration period, study participants were randomly assigned to three groups and asked to consume the provided intervention drug daily for 6 months.
Study: NCT04431960
Study Brief: Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis and CVD Risk
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low-BC Group consume: 1) one tablet containing 392 mg blackcurrant (BC) extract per capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency 0 None 0 16 0 16 View
High-BC Group consume: 1) two capsules containing 392 mg BC extract per tablet (total 784 mg/day) and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency 0 None 0 11 0 11 View
Control Group consume: 1) one placebo capsule and 2) one calcium citrate caplet containing 400 mg calcium and 500 IU vitamin D blackcurrant (BC) extract: A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency 0 None 0 13 0 13 View
Serious Events(If Any):
Other Events(If Any):