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 @ 3:43 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
NCT ID:
NCT02765802
Description:
Based on specific management guidelines for occurrence of Grade 3 AEs and events including hepatobiliary laboratory abnormalities, patients were allowed to interrupt treatment, dose reduce, and/or discontinue Lambda treatment during study. The dose reduction plan allowed patients who were randomized to the Lambda 180 mcg dose to receive Lambda 120 mcg or 80 mcg during study, and patients who were randomized to the Lambda 120 mcg dose to receive Lambda 80 mcg during study.
Frequency Threshold:
5
Time Frame:
Treatment emergent adverse events were collected on or after the first Lambda injection, through 24 weeks post-treatment, an average of 72 weeks.
Study:
NCT02765802
Study Brief:
A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Lambda 180 μg | Lambda 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks. Peginterferon Lambda-1A | 0 | None | 2 | 14 | 14 | 14 | View |
| Lambda 120 μg | Lambda 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks. Peginterferon Lambda-1A | 0 | None | 5 | 19 | 19 | 19 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| Alanine Aminotransferase (ALT) increase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| Aspartate Aminotransferase (AST) Increase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| gamma-glutamyl transferase (GGT) increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| international normalized ratio (INR) increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Rhinorrhea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Feeling cold | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Injection site pruritis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |