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 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
NCT ID:
NCT00788593
Description:
Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. 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.
Frequency Threshold:
0
Time Frame:
Baseline up to final follow-up visit (14 days after end of study)
Study:
NCT00788593
Study Brief:
A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| EUR-1008 (APT-1008) Low Dose | EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period. | None | None | 2 | 74 | 28 | 74 | View |
| EUR-1008 (APT-1008) High Dose | EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period. | None | None | 2 | 75 | 31 | 75 | View |
| Placebo Baseline | Placebo matched to EUR-1008 (APT-1008) capsule orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008). | None | None | 2 | 82 | 34 | 82 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Obstruction gastric | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Pancreatic pseudocyst | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Bile duct obstruction | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (11.0) | View |
| Renal injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Wrist fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Cognitive disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.0) | View |
| Supraventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Blood cholesterol increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Frequent bowel movements | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Steatorrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Stomach discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Blood glucose abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Blood triglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Blood uric acid decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Hepatic enzyme increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Liver function test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Low density lipoprotein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Protein induced by vitamin K absence or antagonist II increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| Hyperlipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| Vitamin A deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| Vitamin E deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Musculoskeletal stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.0) | View |
| Breast tenderness | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11.0) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Sinus congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Sinus operation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (11.0) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |