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 @ 10:38 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
NCT ID:
NCT01458535
Description:
None
Frequency Threshold:
5
Time Frame:
AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 60 weeks).
Study:
NCT01458535
Study Brief:
A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| ABT-450/r and ABT-267 in Genotype 1 Participants | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection. | None | None | 1 | 10 | 9 | 10 | View |
| ABT-450/r and ABT-267 in Genotype 2 Participants | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection. | None | None | 1 | 10 | 9 | 10 | View |
| ABT-450/r and ABT-267 in Genotype 3 Participants | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection. | None | None | 1 | 11 | 10 | 11 | View |
| ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection. | None | None | 1 | 10 | 9 | 10 | View |
| ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection. | None | None | 0 | 10 | 9 | 10 | View |
| ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection. | None | None | 0 | 10 | 8 | 10 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| HAEMATEMESIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| CLOSTRIDIAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| MENINGITIS HERPES | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| FACIAL BONES FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| LUMBAR VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| RIB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| ROAD TRAFFIC ACCIDENT | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| TRAUMATIC LIVER INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| HEPATIC NEOPLASM MALIGNANT | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| PNEUMOTHORAX | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| ARTERIOSCLEROSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| APHTHOUS STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.0 | View |
| LYMPHADENOPATHY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.0 | View |
| EAR PAIN | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 15.0 | View |
| HYPERACUSIS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 15.0 | View |
| GROWTH OF EYELASHES | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| ABDOMINAL DISTENSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| ERUCTATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| FAECES PALE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| FLATULENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| GINGIVAL BLEEDING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| IMPAIRED GASTRIC EMPTYING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| SENSITIVITY OF TEETH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| INFLUENZA LIKE ILLNESS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| IRRITABILITY | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| JAUNDICE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.0 | View |
| HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 15.0 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| GROIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| KIDNEY INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| PHARYNGITIS STREPTOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| TONGUE ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| TOOTH INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| VIRAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| LACERATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| LIGAMENT SPRAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| MUSCLE STRAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| POST-TRAUMATIC PAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| BLOOD BILIRUBIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| BLOOD TRIGLYCERIDES INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| CREATININE RENAL CLEARANCE DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| HAEMOGLOBIN DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| INTRAOCULAR PRESSURE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| URINE OUTPUT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| HYPOPHOSPHATAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| ARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| FLANK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| OSTEOPENIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| LIPOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| SKIN CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| TRANSITIONAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| LETHARGY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| MEMORY IMPAIRMENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| SINUS HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| AGITATION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| PANIC ATTACK | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| DYSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| HAEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| NEPHROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| POLLAKIURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| RENAL FAILURE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| BREAST TENDERNESS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.0 | View |
| CYSTOCELE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.0 | View |
| PROSTATITIS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.0 | View |
| ASTHMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| NASAL CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| RESPIRATORY TRACT CONGESTION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| COLD SWEAT | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| DERMATITIS CONTACT | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| INCREASED TENDENCY TO BRUISE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| URTICARIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| HOT FLUSH | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.0 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.0 | View |