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 @ 2:12 AM
Ignite Modification Date:
2025-12-26 @ 12:39 AM
NCT ID:
NCT01591460
Description:
Safety Population. Participants were grouped by cirrhotic and noncirrhotic status for the safety analysis, regardless of response-guided treatment rules. Therefore, 21 participants were included in the Cirrhotics (Safety) arm to include one additional participant with cirrhosis who did not fulfill response-guided treatment criteria.
Frequency Threshold:
5
Time Frame:
Up to 72 weeks (from Baseline until 24 weeks after EOT)
Study:
NCT01591460
Study Brief:
A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 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 |
|---|---|---|---|---|---|---|---|---|
| Cirrhotics (Safety) | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants with liver cirrhosis were grouped separately in the safety analysis. | None | None | 7 | 21 | 21 | 21 | View |
| Noncirrhotics (Safety) | Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a \<1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants without liver cirrhosis, including those with transition to cirrhosis, were grouped separately in the safety analysis. | None | None | 8 | 144 | 135 | 144 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Granulocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Hepatic failure | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (17.1) | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Road traffic accident | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Hepatic neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | View |
| Hepatocellular carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | View |
| Drug hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (17.1) | View |
| Epididymitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |