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 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:22 AM
NCT ID: NCT02431533
Description: Reporting was performed as per GCP standards
Frequency Threshold: 0
Time Frame: Adverse events were collected during study participation over a 14 week period for each participant.
Study: NCT02431533
Study Brief: The Efficacy of PX0612 In The Treatment Of Irritable Bowel Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Di-Calcium Phosphate Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate Di-Calcium Phosphate: Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate 0 None 0 25 15 25 View
Probiotic PX0612 PX0612 is a probiotic contained in a veggie capsule. PX0612: PX0612 is a probiotic contained in a veggie capsule. 0 None 0 25 7 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
increased bloating/gas NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders bloating/gas View
Hives NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Hives View
Upper respiratory symptoms NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Respiratory View
Increased Restless Leg Syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Restless Leg Syndrom View
Lower back pain NON_SYSTEMATIC_ASSESSMENT General disorders Pain View
Migraine/headache NON_SYSTEMATIC_ASSESSMENT General disorders Migraine/headache View
Thyroiditis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders Thyroiditis View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Vomiting View
Weight gain NON_SYSTEMATIC_ASSESSMENT General disorders Weight changes View
Ear pain/dizziness NON_SYSTEMATIC_ASSESSMENT General disorders Dizziness View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Mood View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders Pain View