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 @ 3:32 AM
Ignite Modification Date: 2025-12-26 @ 2:14 AM
NCT ID: NCT03136705
Description: Adverse event reporting did not differ from what is described under clinicaltrials.gov.
Frequency Threshold: 0
Time Frame: Duration of the study, which with study visit windows was approximately 3 weeks
Study: NCT03136705
Study Brief: Healthy Combine Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lanthanum Placebo + Nicotinamide Placebo Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks Lanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet Nicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet 0 None 0 9 0 9 View
Lanthanum Placebo + Nicotinamide Lanthanum Carbonate Placebo orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks Nicotinamide: Nicotinamide tablet Lanthanum Carbonate Placebo: Sugar pill manufactured to look like Lanthanum Carbonate tablet 0 None 0 10 0 10 View
Lanthanum + Nicotinamide Placebo Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide Placebo orally twice daily for 2 weeks Lanthanum Carbonate: Lanthanum Carbonate tablet Nicotinamide Placebo: Sugar pill manufactured to look like Nicotinamide tablet 0 None 0 10 1 10 View
Lanthanum + Nicotinamide Lanthanum Carbonate 1000mg orally three times daily with meals for 2 weeks and Nicotinamide 750mg orally twice daily for 2 weeks Nicotinamide: Nicotinamide tablet Lanthanum Carbonate: Lanthanum Carbonate tablet 0 None 0 9 0 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View