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 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
NCT ID:
NCT02533934
Description:
All serious adverse events were recorded from time of HCV treatment initiation until last followup for subjects enrolled prospectively (7). For subjects enrolled retrospectively (61), only serious adverse events related to hospitalizations during treatment with sofosbuvir based DAA therapy, anemia require transfusion or EPO during treatment with DAA therapy, or death were recorded.
Frequency Threshold:
0
Time Frame:
Prospective Subjects: from participants first dose until 6 months post treatment discontinuation, through study completion, up to twelve months, plus deaths at any-time. Retrospective Subjects: from participants first dose to end of treatment, through study completion, up to six months, plus deaths at any-time.
Study:
NCT02533934
Study Brief:
Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Adults With HIV and Chronic HCV and End-stage Liver Disease (ESLD) Pre-liver Transplant | The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study. | 10 | None | 18 | 42 | 2 | 42 | View |
| Adults With HIV With Chronic HCV and Any Stage of Liver Disease Post-liver Transplant | The study was implemented at 7 designated sites across the United States. Participants were HIV-positive on a stable antiretroviral (ART) regimen for at least 4 weeks pre-treatment. The retrospective portion of the study enrolled participants treated with sofosbuvir-based DAAs for any duration since 2014 were eligible. HCV genotypes 1, 4, 5 or 6 were included with at least one serum HCV RNA ≥ 1000 IU/mL prior to treatment. Pre-LT participants had a pre-treatment Child's Pugh Turcotte (CPT) score ≥ 7 and a pre-treatment laboratory MELD ≥ 6 and ≤ 30 and included both listed LT candidates and participants who had decompensated cirrhosis not listed for LT. Inclusion criteria for post-LT participants were a LT after 2000 and DAA treatment initiated ≥ 1 month after LT. Prospective participants were accrued from 12/2016-11/2018. Additional exclusion criteria for prospective participants were chronic hepatitis B infection, a history of any other clinically active chronic liver disease, and prior treatment for HCV within one month of screening. Retrospective participants were enrolled between 4/2018 and 6/2019. Information about type of SOF-based therapy in the retrospective participants was not collected for this study. | 3 | None | 7 | 26 | 4 | 26 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalization (Unknown) | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hyperactivity | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Acute Kidney Injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Ampullary stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| DVT | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| esophagogastroduodendoscopy | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Gasteroenteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gout | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Polyp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hyperglycemic seizure | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Kidney stone | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Neck femur fracture | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Polysubstance use | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Unresponsive with hypoactive delirium | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Ventral hernia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headaches | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hyperbilirubiinemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pnemonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |