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 @ 7:19 PM
Ignite Modification Date: 2025-12-25 @ 4:58 PM
NCT ID: NCT01327703
Description: Adverse event (AE) was any untoward medical occurrence regardless of causal relationship to study drug. Serious AE was any event that resulted in death, life threatening, required or prolonged in-patient hospitalization, significant disability/incapacity, or was a congenital anomaly/birth defect. Participants at risk: Panzytrat®=86 and Kreon®=85.
Frequency Threshold: 0
Time Frame: Baseline up to 30 days after last dose
Study: NCT01327703
Study Brief: Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Panzytrat® Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. None None 0 86 32 86 View
Kreon® Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period. None None 0 85 20 85 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Gastrointestinal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Varicella NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.1) View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.1) View
Sputum increased NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.1) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.1) View
Pseudomonas test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (13.1) View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (13.1) View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (13.1) View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Infective pulmonary exacerbation of cystic fibrosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.1) View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.1) View
Vitamin A decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (13.1) View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (13.1) View