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 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
NCT ID:
NCT01023035
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01023035
Study Brief:
Boceprevir/Peginterferon/Ribavirin for Chronic Hepatitis C: Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia (P06086 AM2)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ribavirin Dose Reduction Arm | After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies. | None | None | 39 | 249 | 247 | 249 | View |
| Erythropoietin Use Arm | After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies. | None | None | 33 | 251 | 248 | 251 | View |
| Treated/Not Randomized | Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained \>10 g/dL throughout the 28- or 48-week treatment period. | None | None | 15 | 187 | 180 | 187 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | None | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Leukopenia | None | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Lymphadenopathy | None | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Neutropenia | None | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Acute Myocardial Infarction | None | Cardiac disorders | MedDRA 14.1 | View |
| Atrial Fibrillation | None | Cardiac disorders | MedDRA 14.1 | View |
| Pericardial Effusion | None | Cardiac disorders | MedDRA 14.1 | View |
| Sinus Bradycardia | None | Cardiac disorders | MedDRA 14.1 | View |
| Supraventricular Tachyarrhythmia | None | Cardiac disorders | MedDRA 14.1 | View |
| Tachycardia | None | Cardiac disorders | MedDRA 14.1 | View |
| Vertigo Positional | None | Ear and labyrinth disorders | MedDRA 14.1 | View |
| Hypothyroidism | None | Endocrine disorders | MedDRA 14.1 | View |
| Anal Cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| Basal Cell Carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| Gastrointestinal Neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| Metastases to Lymph Nodes | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| Pancreatic Carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| Pancreatic Neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| Prostate Cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| Renal Cell Carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| Cerebrovascular Accident | None | Nervous system disorders | MedDRA 14.1 | View |
| Dizziness | None | Nervous system disorders | MedDRA 14.1 | View |
| Headache | None | Nervous system disorders | MedDRA 14.1 | View |
| Ischaemic Stroke | None | Nervous system disorders | MedDRA 14.1 | View |
| Migraine | None | Nervous system disorders | MedDRA 14.1 | View |
| Presyncope | None | Nervous system disorders | MedDRA 14.1 | View |
| Syncope | None | Nervous system disorders | MedDRA 14.1 | View |
| Toxic Encephalopathy | None | Nervous system disorders | MedDRA 14.1 | View |
| Transient Ischemic Attack | None | Nervous system disorders | MedDRA 14.1 | View |
| VIIth Nerve Paralysis | None | Nervous system disorders | MedDRA 14.1 | View |
| Depression | None | Psychiatric disorders | MedDRA 14.1 | View |
| Psychotic Disorder | None | Psychiatric disorders | MedDRA 14.1 | View |
| Suicidal Behaviour | None | Psychiatric disorders | MedDRA 14.1 | View |
| Suicidal Ideation | None | Psychiatric disorders | MedDRA 14.1 | View |
| Suicide Attempt | None | Psychiatric disorders | MedDRA 14.1 | View |
| Nephrolithiasis | None | Renal and urinary disorders | MedDRA 14.1 | View |
| Renal Colic | None | Renal and urinary disorders | MedDRA 14.1 | View |
| Adnexa Uteri Mass | None | Reproductive system and breast disorders | MedDRA 14.1 | View |
| Prostatitis | None | Reproductive system and breast disorders | MedDRA 14.1 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Pleurisy | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Pulmonary Embolism | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Respiratory Failure | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Skin Lesion | None | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Arterial Occlusive Disease | None | Vascular disorders | MedDRA 14.1 | View |
| Arteriosclerosis | None | Vascular disorders | MedDRA 14.1 | View |
| Deep Vein Thrombosis | None | Vascular disorders | MedDRA 14.1 | View |
| Hypotension | None | Vascular disorders | MedDRA 14.1 | View |
| Orthostatic Hypotension | None | Vascular disorders | MedDRA 14.1 | View |
| Thrombophlebitis Superficial | None | Vascular disorders | MedDRA 14.1 | View |
| Thrombosed Varicose Vein | None | Vascular disorders | MedDRA 14.1 | View |
| Retinal Detachment | None | Eye disorders | MedDRA 14.1 | View |
| Abominal Pain | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Abdominal Pain Upper | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Anal Fissure | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Colitis | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Gastrooesophageal Reflux Disease | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Inguinal Hernia | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Lower Gastrointestinal Haemorrhage | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Megacolon | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Oesophagitis | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Rectal Haemorrhage | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Upper Gastrointestinal Haemorrhage | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Asthenia | None | General disorders | MedDRA 14.1 | View |
| Chest Pain | None | General disorders | MedDRA 14.1 | View |
| Fatigue | None | General disorders | MedDRA 14.1 | View |
| Irritability | None | General disorders | MedDRA 14.1 | View |
| Pain | None | General disorders | MedDRA 14.1 | View |
| Pyrexia | None | General disorders | MedDRA 14.1 | View |
| Sudden Cardiac Death | None | General disorders | MedDRA 14.1 | View |
| Cholelithiasis | None | Hepatobiliary disorders | MedDRA 14.1 | View |
| Cholelithiasis Obstructive | None | Hepatobiliary disorders | MedDRA 14.1 | View |
| Abscess Soft Tissue | None | Infections and infestations | MedDRA 14.1 | View |
| Appendicitis | None | Infections and infestations | MedDRA 14.1 | View |
| Bronchitis | None | Infections and infestations | MedDRA 14.1 | View |
| Cellulitis | None | Infections and infestations | MedDRA 14.1 | View |
| Clostridium Difficile Colitis | None | Infections and infestations | MedDRA 14.1 | View |
| Corneal Abscess | None | Infections and infestations | MedDRA 14.1 | View |
| Endocarditis | None | Infections and infestations | MedDRA 14.1 | View |
| Gastroenteritis | None | Infections and infestations | MedDRA 14.1 | View |
| Infected Skin Ulcer | None | Infections and infestations | MedDRA 14.1 | View |
| Kidney Infection | None | Infections and infestations | MedDRA 14.1 | View |
| Pneumonia | None | Infections and infestations | MedDRA 14.1 | View |
| Tubo-ovarian Abscess | None | Infections and infestations | MedDRA 14.1 | View |
| Upper Respiratory Tract Infection | None | Infections and infestations | MedDRA 14.1 | View |
| Urinary Tract Infection | None | Infections and infestations | MedDRA 14.1 | View |
| Accidental Overdose | None | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Ankle Fracture | None | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Fibula Fracture | None | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Multiple Drug Overdose | None | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Operative Haemorrhage | None | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Overdose | None | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Post Procedural Haemorrhage | None | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Snake Bite | None | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Traumatic Liver Injury | None | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Blood Potassium Decreased | None | Investigations | MedDRA 14.1 | View |
| Neutrophil Count Decreased | None | Investigations | MedDRA 14.1 | View |
| Decreased Appetite | None | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Dehydration | None | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Diabetes Melllitus | None | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Hypoglycemia | None | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Hyponatremia | None | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Arthraliga | None | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Back Pain | None | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Pain in Extremity | None | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | None | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Leukopenia | None | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Neutropenia | None | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Hypothyroidism | None | Endocrine disorders | MedDRA 14.1 | View |
| Vision Blurred | None | Eye disorders | MedDRA 14.1 | View |
| Abdominal Pain | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Abdominal Pain Upper | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Dry Mouth | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Dysguesia | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Dyspepsia | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Gastrooesophageal Reflux Disease | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Mouth Ulceration | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Stomatitis | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 14.1 | View |
| Asthenia | None | General disorders | MedDRA 14.1 | View |
| Chills | None | General disorders | MedDRA 14.1 | View |
| Fatigue | None | General disorders | MedDRA 14.1 | View |
| Influenza Like Illness | None | General disorders | MedDRA 14.1 | View |
| Injection Site Erythema | None | General disorders | MedDRA 14.1 | View |
| Injection Site Reaction | None | General disorders | MedDRA 14.1 | View |
| Irritability | None | General disorders | MedDRA 14.1 | View |
| Oedema Peripheral | None | General disorders | MedDRA 14.1 | View |
| Pain | None | General disorders | MedDRA 14.1 | View |
| Pyrexia | None | General disorders | MedDRA 14.1 | View |
| Bronchitis | None | Infections and infestations | MedDRA 14.1 | View |
| Upper Respiratory Tract Infection | None | Infections and infestations | MedDRA 14.1 | View |
| Urinary Tract Infection | None | Infections and infestations | MedDRA 14.1 | View |
| Weight Decreased | None | Investigations | MedDRA 14.1 | View |
| Decreased Appetite | None | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Back Pain | None | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Muscle Spasms | None | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Pain in Extremity | None | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | View |
| Disturbance in Attention | None | Nervous system disorders | MedDRA 14.1 | View |
| Dizziness | None | Nervous system disorders | MedDRA 14.1 | View |
| Headache | None | Nervous system disorders | MedDRA 14.1 | View |
| Hypoaesthesia | None | Nervous system disorders | MedDRA 14.1 | View |
| Paraesthesia | None | Nervous system disorders | MedDRA 14.1 | View |
| Affect Lability | None | Psychiatric disorders | MedDRA 14.1 | View |
| Anxiety | None | Psychiatric disorders | MedDRA 14.1 | View |
| Depression | None | Psychiatric disorders | MedDRA 14.1 | View |
| Insomnia | None | Psychiatric disorders | MedDRA 14.1 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Dyspnoea Exertional | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Oropharyngeal Pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Productive Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | View |
| Alopecia | None | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Dry Skin | None | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Pruritis | None | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Rash Generalised | None | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |