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 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
NCT ID:
NCT00087633
Description:
Safety Population: 54 patients in the prophylaxis arm, and 60 patients in the observation arm. One patient randomized to the prophylaxis arm was excluded from the safety population because they withdrew consent before receiving any study medication and did not have any postbaseline assessments.
Frequency Threshold:
0
Time Frame:
Adverse Events were collected for the period of the study (4 years, 12-Oct-2004 - 17-Oct-2008)
Study:
NCT00087633
Study Brief:
PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for 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 |
|---|---|---|---|---|---|---|---|---|
| Prophylaxis Arm | Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients \<75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally | None | None | 25 | 54 | 54 | 54 | View |
| Observation Arm | No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin) | None | None | 21 | 60 | 58 | 60 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infections and infestations | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Gastrointestinal disorders | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Hepatobiliary disorders | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (11.0) | View |
| Blood and lymphatic system disordersimag | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.0) | View |
| Cardiac disorders | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Investigations | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Surgical and medical proceduresi | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (11.0) | View |
| Immune system disorders | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (11.0) | View |
| Reproductive system and breast disorders | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11.0) | View |
| Respiratory, thoracic and mediastinal disorders | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| General disorders and administration site conditions | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Injury, poisoning and procedural complicationsE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Nervous system disorders | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Metabolism and nutrition disorders | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| Renal and urinary disorders | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
| Neoplasms benign, malignant and unspecified | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | View |
| Endocrine disorders | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (11.0) | View |
| Vascular disorders | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| General Disorders and administration site conditions | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| Gastrointestinal disorders | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| Blood and lymphatic system disorders | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.0) | View |
| Nervous system disorders | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| Musculoskeletal and connective tissue disorders | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| Psychiatric disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.0) | View |
| Infections and infestations | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| Skin and subcutaneous tissue disorders | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| Investigations | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| Respiratory, thoracic and mediastinal disorders | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Metabolism and nutrition disorders | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| Injury, poisoning and procedural complications | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| Renal and urinary disorders | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
| Vascular disorders | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| Eye disorders | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11.0) | View |
| Hepatobiliary disorders | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (11.0) | View |
| Reproductive system and breast disorders | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11.0) | View |
| Neoplasms benign, malignant and unspecified | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | View |
| Surgical and medical procedures | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (11.0) | View |
| Ear and labyrinth disorders | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (11.0) | View |
| Cardiac disorders | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| Endocrine disorders | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (11.0) | View |
| Social circumstances | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (11.0) | View |
| Immune system disorders | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (11.0) | View |