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 @ 3:22 PM
Ignite Modification Date:
2025-12-25 @ 1:41 PM
NCT ID:
NCT01466192
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01466192
Study Brief:
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| MP-424 | MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks | None | None | 12 | 108 | 108 | 108 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bladder cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Hepatocellular carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Decreased appetite | None | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Gastrointestinal disorder | None | Gastrointestinal disorders | MedDRA 16.0 | View |
| Large intestine polyp | None | Gastrointestinal disorders | MedDRA 16.0 | View |
| Hepatic function abnormal | None | Hepatobiliary disorders | MedDRA 16.0 | View |
| Erythema multiforme | None | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Rhabdomyolysis | None | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Renal impairment | None | Renal and urinary disorders | MedDRA 16.0 | View |
| Malaise | None | General disorders | MedDRA 16.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | None | Infections and infestations | MedDRA 16.0 | View |
| Anaemia | None | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Decreased appetite | None | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hyperuricaemia | None | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hypokalaemia | None | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Insomnia | None | Psychiatric disorders | MedDRA 16.0 | View |
| Headache | None | Nervous system disorders | MedDRA 16.0 | View |
| Dysgeusia | None | Nervous system disorders | MedDRA 16.0 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA 16.0 | View |
| Abdominal discomfort | None | Gastrointestinal disorders | MedDRA 16.0 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 16.0 | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA 16.0 | View |
| Stomatitis | None | Gastrointestinal disorders | MedDRA 16.0 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA 16.0 | View |
| Cheilitis | None | Gastrointestinal disorders | MedDRA 16.0 | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Alopecia | None | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Drug eruption | None | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Eczema | None | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Dry skin | None | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Pyrexia | None | General disorders | MedDRA 16.0 | View |
| Malaise | None | General disorders | MedDRA 16.0 | View |
| Injection site erythema | None | General disorders | MedDRA 16.0 | View |
| Injection site reaction | None | General disorders | MedDRA 16.0 | View |
| Influenza like illness | None | General disorders | MedDRA 16.0 | View |
| Thirst | None | General disorders | MedDRA 16.0 | View |
| White blood cell count decreased | None | Investigations | MedDRA 16.0 | View |
| Platelet count decreased | None | Investigations | MedDRA 16.0 | View |
| Blood creatinine increased | None | Investigations | MedDRA 16.0 | View |
| Blood uric acid increased | None | Investigations | MedDRA 16.0 | View |
| Hyaluronic acid increased | None | Investigations | MedDRA 16.0 | View |
| Blood triglycerides increased | None | Investigations | MedDRA 16.0 | View |
| Blood bilirubin increased | None | Investigations | MedDRA 16.0 | View |
| Blood potassium decreased | None | Investigations | MedDRA 16.0 | View |
| Blood phosphorus decreased | None | Investigations | MedDRA 16.0 | View |
| Haemoglobin decreased | None | Investigations | MedDRA 16.0 | View |
| Alanine aminotransferase increased | None | Investigations | MedDRA 16.0 | View |
| Gamma-glutamyltransferase increased | None | Investigations | MedDRA 16.0 | View |