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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
NCT ID:
NCT00630058
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00630058
Study Brief:
A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group A (MP-424 High) | Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks | None | None | 2 | 10 | 10 | 10 | View |
| Group B (MP-424 Low) | Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks | None | None | 2 | 10 | 10 | 10 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | None | Blood and lymphatic system disorders | MedDRA 12.0 | View |
| Appetite disorders | None | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Dizziness | None | Nervous system disorders | MedDRA 12.0 | View |
| Vertigo | None | Ear and labyrinth disorders | MedDRA 12.0 | View |
| Drug eruption | None | Skin and subcutaneous tissue disorders | MedDRA 12.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | None | Infections and infestations | MedDRA 12.0 | View |
| Anaemia | None | Blood and lymphatic system disorders | MedDRA 12.0 | View |
| Hyperuricaemia | None | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Decreased appetite | None | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Insomnia | None | Psychiatric disorders | MedDRA 12.0 | View |
| Headache | None | Nervous system disorders | MedDRA 12.0 | View |
| Dysgeusia | None | Nervous system disorders | MedDRA 12.0 | View |
| Dizziness | None | Nervous system disorders | MedDRA 12.0 | View |
| Vertigo | None | Ear and labyrinth disorders | MedDRA 12.0 | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Dyspepsia | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Periodontitis | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Abdominal discomfort | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Stomatitis | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Haemorrhoids | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Proctalgia | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA 12.0 | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | MedDRA 12.0 | View |
| Alopecia | None | Skin and subcutaneous tissue disorders | MedDRA 12.0 | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Musculoskeletal pain | None | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Nocturia | None | Renal and urinary disorders | MedDRA 12.0 | View |
| Pyrexia | None | General disorders | MedDRA 12.0 | View |
| Malaise | None | General disorders | MedDRA 12.0 | View |
| Influenza like illness | None | General disorders | MedDRA 12.0 | View |
| Low density lipoprotein increased | None | Investigations | MedDRA 12.0 | View |
| Blood uric acid increased | None | Investigations | MedDRA 12.0 | View |
| Blood triglycerides increased | None | Investigations | MedDRA 12.0 | View |
| Blood creatinine increased | None | Investigations | MedDRA 12.0 | View |
| Blood lactate dehydrogenase increased | None | Investigations | MedDRA 12.0 | View |
| Blood luteinising hormone increased | None | Investigations | MedDRA 12.0 | View |
| Eosinophil percentage increased | None | Investigations | MedDRA 12.0 | View |
| Lymphocyte percentage decreased | None | Investigations | MedDRA 12.0 | View |
| Blood cholesterol increased | None | Investigations | MedDRA 12.0 | View |
| Platelet count decreased | None | Investigations | MedDRA 12.0 | View |
| White blood cell count decreased | None | Investigations | MedDRA 12.0 | View |
| Protein urine present | None | Investigations | MedDRA 12.0 | View |
| Lymphocyte percentage increased | None | Investigations | MedDRA 12.0 | View |
| Blood potassium decreased | None | Investigations | MedDRA 12.0 | View |
| Neutrophil count decreased | None | Investigations | MedDRA 12.0 | View |
| Basophil percentage decreased | None | Investigations | MedDRA 12.0 | View |
| Alanine aminotransferase increased | None | Investigations | MedDRA 12.0 | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA 12.0 | View |
| Blood bilirubin unconjugated increased | None | Investigations | MedDRA 12.0 | View |
| Lipids abnormal | None | Investigations | MedDRA 12.0 | View |
| Monocyte percentage increased | None | Investigations | MedDRA 12.0 | View |
| Bilirubin conjugated increased | None | Investigations | MedDRA 12.0 | View |
| Eosinophil percentage decreased | None | Investigations | MedDRA 12.0 | View |
| Protein total decreased | None | Investigations | MedDRA 12.0 | View |
| Blood albumin decreased | None | Investigations | MedDRA 12.0 | View |
| Blood alkaline phosphatase increased | None | Investigations | MedDRA 12.0 | View |
| Deafness | None | Ear and labyrinth disorders | MedDRA 12.0 | View |
| Cystitis | None | Infections and infestations | MedDRA 12.0 | View |
| Tinea pedis | None | Infections and infestations | MedDRA 12.0 | View |
| Abdominal distension | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Abdominal pain lower | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Cheilitis | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Frequent bowel movement | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Gastritis | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Reflux oesophagitis | None | Gastrointestinal disorders | MedDRA 12.0 | View |
| Injection site erythema | None | General disorders | MedDRA 12.0 | View |
| Injection site reaction | None | General disorders | MedDRA 12.0 | View |
| Gout | None | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Somnolence | None | Nervous system disorders | MedDRA 12.0 | View |
| Syncope | None | Nervous system disorders | MedDRA 12.0 | View |
| Affective disorder | None | Psychiatric disorders | MedDRA 12.0 | View |
| Anxiety | None | Psychiatric disorders | MedDRA 12.0 | View |
| Depression | None | Psychiatric disorders | MedDRA 12.0 | View |
| Blood bilirubin increased | None | Investigations | MedDRA 12.0 | View |
| Blood calcium decreased | None | Investigations | MedDRA 12.0 | View |
| Blood glucose increased | None | Investigations | MedDRA 12.0 | View |
| Blood pressure decreased | None | Investigations | MedDRA 12.0 | View |
| Blood pressure increased | None | Investigations | MedDRA 12.0 | View |
| Blood thyroid stimulating hormone increased | None | Investigations | MedDRA 12.0 | View |
| C-reactive protein increased | None | Investigations | MedDRA 12.0 | View |
| Eosinophil count increased | None | Investigations | MedDRA 12.0 | View |
| High density lipoprotein decreased | None | Investigations | MedDRA 12.0 | View |
| Reticulocyte count increased | None | Investigations | MedDRA 12.0 | View |
| Neutrophil percentage decreased | None | Investigations | MedDRA 12.0 | View |
| Neutrophil percentage increased | None | Investigations | MedDRA 12.0 | View |
| Tri-iodothyronine free decreased | None | Investigations | MedDRA 12.0 | View |
| Drug eruption | None | Skin and subcutaneous tissue disorders | MedDRA 12.0 | View |
| Pain of skin | None | Skin and subcutaneous tissue disorders | MedDRA 12.0 | View |
| Skin discomfort | None | Skin and subcutaneous tissue disorders | MedDRA 12.0 | View |
| Tachycardia | None | Cardiac disorders | MedDRA 12.0 | View |
| Hypotension | None | Vascular disorders | MedDRA 12.0 | View |
| Abnormal sensation in eye | None | Eye disorders | MedDRA 12.0 | View |
| Eye discharge | None | Eye disorders | MedDRA 12.0 | View |
| Visual impairment | None | Eye disorders | MedDRA 12.0 | View |
| Eye pruritus | None | Eye disorders | MedDRA 12.0 | View |
| Skin exfoliation | None | Skin and subcutaneous tissue disorders | MedDRA 12.0 | View |
| Choking sensation | None | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Nasal congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Productive cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Rhinorrhoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Oropharyngeal discomfort | None | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Haematuria | None | Renal and urinary disorders | MedDRA 12.0 | View |
| Pollakiuria | None | Renal and urinary disorders | MedDRA 12.0 | View |
| Anorexia | None | Metabolism and nutrition disorders | MedDRA 12.0 | View |