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 @ 12:57 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
NCT ID:
NCT00793793
Description:
None
Frequency Threshold:
5
Time Frame:
day 1 and up to 4 weeks + washout
Study:
NCT00793793
Study Brief:
Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
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 (TN): Placebo | TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days | None | None | 0 | 8 | 5 | 8 | View |
| Treatment Naive(TN): 20mg QD | TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days | None | None | 1 | 6 | 6 | 6 | View |
| TN: 48mg QD | TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days | None | None | 1 | 7 | 7 | 7 | View |
| TN: 120mg QD | TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days | None | None | 0 | 7 | 4 | 7 | View |
| TN: 240mg QD | TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days | None | None | 0 | 6 | 6 | 6 | View |
| Treatment Experienced (TE) Non-cirrhotic: 48 mg QD | TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days | None | None | 0 | 6 | 6 | 6 | View |
| TE Non-cirrhotic: 120 mg QD | TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days | None | None | 0 | 7 | 7 | 7 | View |
| TE Non-cirrhotic: 240 mg QD | TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days | None | None | 0 | 6 | 6 | 6 | View |
| TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC) | TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days | None | None | 0 | 15 | 15 | 15 | View |
| TE Non-cirrhotic: 240 mg BID SGC | TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days | None | None | 0 | 15 | 15 | 15 | View |
| TE With Cirrhosis: 240 mg QD SGC | TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days | None | None | 0 | 6 | 6 | 6 | View |
| TE With Cirrhosis: 240 mg BID SGC | TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days | None | None | 2 | 7 | 7 | 7 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 13.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 13.1 | View |
| Metabolic disorder | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 13.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 13.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 13.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 13.1 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 13.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 13.1 | View |
| Supraventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 13.1 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MEDDRA 13.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MEDDRA 13.1 | View |
| Abnormal sensation in eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 13.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 13.1 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 13.1 | View |
| Erythema of eyelid | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 13.1 | View |
| Eyelids pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 13.1 | View |
| Ocular icterus | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 13.1 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 13.1 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 13.1 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MEDDRA 13.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Anal pruritus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Aphthous stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Faeces discoloured | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Irritable bowel syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Lip dry | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Periodontitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 13.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Exercise tolerance decreased | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Feeling abnormal | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Feeling cold | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Hyperthermia | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Injection site rash | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Mucosal dryness | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Mucosal ulceration | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 13.1 | View |
| Hepatic pain | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 13.1 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 13.1 | View |
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 13.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 13.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 13.1 | View |
| Gingival abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 13.1 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 13.1 | View |
| Herpes virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 13.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 13.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 13.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 13.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 13.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 13.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 13.1 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 13.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 13.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 13.1 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 13.1 | View |
| Scratch | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 13.1 | View |
| Sunburn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEDDRA 13.1 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 13.1 | View |
| Body temperature increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 13.1 | View |
| Breath sounds abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 13.1 | View |
| Cardiac murmur | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 13.1 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 13.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 13.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 13.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 13.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 13.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 13.1 | View |
| Fibromyalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 13.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 13.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 13.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 13.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 13.1 | View |
| Amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 13.1 | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 13.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 13.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 13.1 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 13.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 13.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 13.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 13.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 13.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 13.1 | View |
| Affect lability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 13.1 | View |
| Aggression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 13.1 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 13.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 13.1 | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 13.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 13.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 13.1 | View |
| Mood altered | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 13.1 | View |
| Mood swings | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 13.1 | View |
| Chromaturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 13.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 13.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 13.1 | View |
| Renal pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 13.1 | View |
| Urine odour abnormal | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 13.1 | View |
| Testicular pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEDDRA 13.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 13.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 13.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 13.1 | View |
| Larynx irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 13.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 13.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 13.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Cold sweat | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Photosensitivity allergic reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Photosensitivity reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Rash papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Skin irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Skin reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | View |
| Dental implantation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MEDDRA 13.1 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 13.1 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 13.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 13.1 | View |