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 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:08 PM
NCT ID:
NCT00999167
Description:
None
Frequency Threshold:
5
Time Frame:
Part A: 28 days Part B: 112 days
Study:
NCT00999167
Study Brief:
A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part A: HPN-100 | 6 mL BID for 7 days followed by 9 mL BID for 21 days, equivalent to approximately 13.2 and 19.8 grams of HPN-100/day, respectively | None | None | 5 | 15 | 11 | 15 | View |
| Part B: HPN-100 | 6 mL BID, equivalent to approximately 13.2 grams of HPN-100/day | None | None | 20 | 90 | 71 | 90 | View |
| Part B: Placebo | Matching HPN-100 placebo, 6 mL BID | None | None | 12 | 88 | 67 | 88 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal haemorrhage | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Urinary tract infections | None | Infections and infestations | MedDRA (12.0) | View |
| Peritonitis bacterial | None | Infections and infestations | MedDRA (12.0) | View |
| Cellulitis | None | Infections and infestations | MedDRA (12.0) | View |
| Sepsis | None | Infections and infestations | MedDRA (12.0) | View |
| Urosepsis | None | Infections and infestations | MedDRA (12.0) | View |
| Hepatic failure | None | Hepatobiliary disorders | MedDRA (12.0) | View |
| Cholelithiasis | None | Hepatobiliary disorders | MedDRA (12.0) | View |
| Hepatic cirrhosis | None | Hepatobiliary disorders | MedDRA (12.0) | View |
| Hepatorenal syndrome | None | Hepatobiliary disorders | MedDRA (12.0) | View |
| Liver disorder | None | Hepatobiliary disorders | MedDRA (12.0) | View |
| Hyperglycaemia | None | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hypoglycaemia | None | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hyponatraemia | None | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Diabetes mellitus inadequate control | None | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Ascites | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Abdominal Pain | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Oesophageal varices haemorrhage | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Renal failure acute | None | Renal and urinary disorders | MedDRA (12.0) | View |
| Renal failure | None | Renal and urinary disorders | MedDRA (12.0) | View |
| Renal impairment | None | Renal and urinary disorders | MedDRA (12.0) | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Respiratory failure | None | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |
| Anaemia | None | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| Haemoglobin decreased | None | Investigations | MedDRA (12.0) | View |
| Transaminases increased | None | Investigations | MedDRA (12.0) | View |
| Epilepsy | None | Nervous system disorders | MedDRA (12.0) | View |
| Syncope | None | Nervous system disorders | MedDRA (12.0) | View |
| Bradycardia | None | Cardiac disorders | MedDRA (12.0) | View |
| Postural orthostatic tachycardia syndrome | None | Cardiac disorders | MedDRA (12.0) | View |
| Humerus fracture | None | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Pelvic fracture | None | Injury, poisoning and procedural complications | MedDRA (12.0) | View |
| Acute psychosis | None | Psychiatric disorders | MedDRA (12.0) | View |
| Psychotic disorder | None | Psychiatric disorders | MedDRA (12.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| abdominal pain | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Ascites | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Oedema peripheral | None | General disorders | MedDRA (12.0) | View |
| Fatigue | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| Pyrexia | None | General disorders | MedDRA (12.0) | View |
| ALT increased | None | Investigations | MedDRA (12.0) | View |
| White blood cell count (WBC) decreased | None | Investigations | MedDRA (12.0) | View |
| Headache | None | Nervous system disorders | MedDRA (12.0) | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Urinary tract infection | None | Infections and infestations | MedDRA (12.0) | View |
| Hypokalaemia | None | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hypoglycaemia | None | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Hyponatraemia | None | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Thrombocytopenia | None | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| Constipation | None | Gastrointestinal disorders | MedDRA (12.0) | View |
| AST increased | None | Investigations | MedDRA (12.0) | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | View |