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 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
NCT ID:
NCT01528735
Description:
None
Frequency Threshold:
5
Time Frame:
From first dose of study medication until 30 days after last dose of study medication, up to 199 days
Study:
NCT01528735
Study Brief:
This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic 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 |
|---|---|---|---|---|---|---|---|---|
| Faldap/Del/RBV:80mg Faldap and 600mg Del. | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir (del) and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV) | None | None | 0 | 12 | 12 | 12 | View |
| Faldap/Del/RBV:120mg Faldap and 600mg Del. | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir (del) and 120 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV) | None | None | 0 | 13 | 13 | 13 | View |
| Faldap/pegIFN/RBV:80mg Faldap and 600mg Del. | Patients received 24 weeks 120 mg once daily (qd) faldaprevir (faldap) in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV), following treatment of 8 weeks of 600mg twice daily (bid) deleobuvir (del) and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV). | None | None | 1 | 11 | 11 | 11 | View |
| Faldap/pegIFN/RBV:120mg Faldap and 600mg Del. | Patients received 24 weeks 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV), following treatment of 8 weeks of 600mg twice daily (bid.) deleobuvir (del) and 120 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV). | None | None | 0 | 12 | 11 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 16.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 16.1 | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 16.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 16.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 16.1 | View |
| Conjunctival hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 16.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 16.1 | View |
| Eyelid oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 16.1 | View |
| Ocular hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 16.1 | View |
| Retinal degeneration | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 16.1 | View |
| Retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 16.1 | View |
| Scintillating scotoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 16.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 16.1 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 16.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 16.1 | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 16.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 16.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 16.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 16.1 | View |
| Epigastric discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 16.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 16.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 16.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 16.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 16.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 16.1 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 16.1 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 16.1 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 16.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 16.1 | View |
| Mass | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 16.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 16.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 16.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 16.1 | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 16.1 | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 16.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 16.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 16.1 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 16.1 | View |
| Sunburn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 16.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 16.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 16.1 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 16.1 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 16.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 16.1 | View |
| Red blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 16.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 16.1 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 16.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 16.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 16.1 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 16.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 16.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 16.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 16.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 16.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 16.1 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 16.1 | View |
| Depressive symptom | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 16.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 16.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | View |
| Upper respiratory tract inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | View |
| Tanning | SYSTEMATIC_ASSESSMENT | Social circumstances | MEDDRA 16.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 16.1 | View |
| Retinal exudates | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 16.1 | View |
| Retinal haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 16.1 | View |
| Retinal tear | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 16.1 | View |
| Oral discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 16.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 16.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 16.1 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 16.1 | View |
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 16.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 16.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 16.1 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 16.1 | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 16.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 16.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 16.1 | View |
| Excoriation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 16.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 16.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 16.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 16.1 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 16.1 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | View |
| Eczema asteatotic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | View |
| Ingrowing nail | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | View |
| Photodermatosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | View |
| Photosensitivity reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | View |
| Pigmentation disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | View |