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 @ 4:23 AM
Ignite Modification Date: 2025-12-26 @ 3:26 AM
NCT ID: NCT00690820
Description: Only Treatment Emergent Adverse events are presented.
Frequency Threshold: 5
Time Frame: The adverse events were collected from Screening to the end of the second period of the cross-over trial. A safety follow-up call was performed 5-7 days after the last visit to the clinic.
Study: NCT00690820
Study Brief: Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)
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 Placebo treatment None None 0 16 9 16 View
Pancrelipase Pancrelipase delayed release 12000 units treatment None None 0 17 5 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rectal Discharge NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.1 View
Faecal Volume Increased NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.1 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.1 View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.1 View
Frequent Bowel Movements NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.1 View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.1 View
Weight Decrease NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 8.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 8.1 View
Cold sweat NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 8.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 8.1 View
Rash Macular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 8.1 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 8.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 8.1 View