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 @ 6:47 PM
Ignite Modification Date:
2025-12-25 @ 4:19 PM
NCT ID:
NCT01753557
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01753557
Study Brief:
Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed 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 |
|---|---|---|---|---|---|---|---|---|
| Treatment-Naive | Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks | None | None | 0 | 35 | 35 | 35 | View |
| Treatment-Relapsed | Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks | None | None | 2 | 19 | 19 | 19 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | None | Infections and infestations | MedDRA 17.1 | View |
| Periodontitis | None | Infections and infestations | MedDRA 17.1 | View |
| Anaemia | None | Blood and lymphatic system disorders | MedDRA 17.1 | View |
| Hyperuricaemia | None | Metabolism and nutrition disorders | MedDRA 17.1 | View |
| Decreased appetite | None | Metabolism and nutrition disorders | MedDRA 17.1 | View |
| Insomnia | None | Psychiatric disorders | MedDRA 17.1 | View |
| Headache | None | Nervous system disorders | MedDRA 17.1 | View |
| Dysgeusia | None | Nervous system disorders | MedDRA 17.1 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Stomatitis | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Abdominal discomfort | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Drug eruption | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Alopecia | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Rash maculo-papular | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Pruritus generalised | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Dry skin | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | View |
| Renal impairment | None | Renal and urinary disorders | MedDRA 17.1 | View |
| Pyrexia | None | General disorders | MedDRA 17.1 | View |
| Malaise | None | General disorders | MedDRA 17.1 | View |
| Injection site erythema | None | General disorders | MedDRA 17.1 | View |
| Injection site reaction | None | General disorders | MedDRA 17.1 | View |
| Thirst | None | General disorders | MedDRA 17.1 | View |
| White blood cell count decreased | None | Investigations | MedDRA 17.1 | View |
| Platelet count decreased | None | Investigations | MedDRA 17.1 | View |
| Blood uric acid increased | None | Investigations | MedDRA 17.1 | View |
| Blood bilirubin increased | None | Investigations | MedDRA 17.1 | View |
| Blood triglycerides increased | None | Investigations | MedDRA 17.1 | View |
| Hyaluronic acid increased | None | Investigations | MedDRA 17.1 | View |
| Blood potassium decreased | None | Investigations | MedDRA 17.1 | View |
| Urinary tract infection | None | Infections and infestations | MedDRA 17.1 | View |
| Folliculitis | None | Infections and infestations | MedDRA 17.1 | View |
| Hordeolum | None | Infections and infestations | MedDRA 17.1 | View |
| Cystitis | None | Infections and infestations | MedDRA 17.1 | View |
| Oral herpes | None | Infections and infestations | MedDRA 17.1 | View |
| Furuncle | None | Infections and infestations | MedDRA 17.1 | View |
| Herpes simplex | None | Infections and infestations | MedDRA 17.1 | View |
| Influenza | None | Infections and infestations | MedDRA 17.1 | View |
| Pharyngitis | None | Infections and infestations | MedDRA 17.1 | View |
| Enterocolitis viral | None | Infections and infestations | MedDRA 17.1 | View |
| Lipid metabolism disorder | None | Metabolism and nutrition disorders | MedDRA 17.1 | View |
| Depressive symptom | None | Psychiatric disorders | MedDRA 17.1 | View |
| Hypoaesthesia | None | Nervous system disorders | MedDRA 17.1 | View |
| Dizziness | None | Nervous system disorders | MedDRA 17.1 | View |
| Migraine | None | Nervous system disorders | MedDRA 17.1 | View |
| Presyncope | None | Nervous system disorders | MedDRA 17.1 | View |
| Retinopathy | None | Eye disorders | MedDRA 17.1 | View |
| Vision blurred | None | Eye disorders | MedDRA 17.1 | View |
| Asthenopia | None | Eye disorders | MedDRA 17.1 | View |
| Eye pain | None | Eye disorders | MedDRA 17.1 | View |
| Oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | View |
| Dyspepsia | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Cheilitis | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Abdominal pain lower | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Glossitis | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Oral pain | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Proctalgia | None | Gastrointestinal disorders | MedDRA 17.1 | View |
| Hepatic function abnormal | None | Hepatobiliary disorders | MedDRA 17.1 | View |
| Hepatic steatosis | None | Hepatobiliary disorders | MedDRA 17.1 | View |
| Hyperbilirubinaemia | None | Hepatobiliary disorders | MedDRA 17.1 | View |
| Palmoplantar keratoderma | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Dyshidrotic eczema | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Eczema asteatotic | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Erythema | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Erythema multiforme | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Papule | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Pollakiuria | None | Renal and urinary disorders | MedDRA 17.1 | View |
| Oedema peripheral | None | General disorders | MedDRA 17.1 | View |
| Feeling hot | None | General disorders | MedDRA 17.1 | View |
| Liver function test abnormal | None | Investigations | MedDRA 17.1 | View |
| Neutrophil count decreased | None | Investigations | MedDRA 17.1 | View |
| Gamma-glutamyltransferase increased | None | Investigations | MedDRA 17.1 | View |
| Blood lactate dehydrogenase increased | None | Investigations | MedDRA 17.1 | View |
| Lymphocyte count decreased | None | Investigations | MedDRA 17.1 | View |
| Blood phosphorus decreased | None | Investigations | MedDRA 17.1 | View |
| Blood alkaline phosphatase increased | None | Investigations | MedDRA 17.1 | View |
| Bilirubin conjugated increased | None | Investigations | MedDRA 17.1 | View |
| Arthropod sting | None | Injury, poisoning and procedural complications | MedDRA 17.1 | View |
| Arthropod bite | None | Injury, poisoning and procedural complications | MedDRA 17.1 | View |
| Retinal haemorrhage | None | Eye disorders | MedDRA 17.1 | View |
| Cataract | None | Eye disorders | MedDRA 17.1 | View |
| Eye discharge | None | Eye disorders | MedDRA 17.1 | View |
| Punctate keratitis | None | Eye disorders | MedDRA 17.1 | View |
| Retinal vein occlusion | None | Eye disorders | MedDRA 17.1 | View |
| Eye pruritus | None | Eye disorders | MedDRA 17.1 | View |
| Vertigo | None | Ear and labyrinth disorders | MedDRA 17.1 | View |
| Ear pain | None | Ear and labyrinth disorders | MedDRA 17.1 | View |
| Cerumen impaction | None | Ear and labyrinth disorders | MedDRA 17.1 | View |
| Hypertension | None | Vascular disorders | MedDRA 17.1 | View |
| Photosensitivity reaction | None | Skin and subcutaneous tissue disorders | MedDRA 17.1 | View |
| Muscle spasms | None | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | View |
| Hypothyroidism | None | Endocrine disorders | MedDRA 17.1 | View |
| Blood creatinine increased | None | Investigations | MedDRA 17.1 | View |
| Dry eye | None | Eye disorders | MedDRA 17.1 | View |