Adverse Events Module

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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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT02430194
Description: None
Frequency Threshold: 0
Time Frame: treatment period 12-48 weeks
Study: NCT02430194
Study Brief: Lonafarnib Boosted With Ritonavir With and Without Peginterferon Alfa-2a (PEG IFN-a) in HDV (LOWR-2)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lonafarnib/Ritonavir/PEG IFN-a - IX lonafarnib 25 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 mcg QW for 24 weeks 0 None 1 7 7 7 View
Lonafarnib/Ritonavir/PEG IFN-a - X lonafarnib 50 mg BID + ritonavir 100 mg BID + PEG IFN-a 180 mcg QW for 24 weeks 0 None 1 5 5 5 View
Lonafarnib/Ritonavir - I lonafarnib 100 mg BID + ritonavir 100 mg QD for 12 weeks 0 None 0 4 4 4 View
Lonafarnib/Ritonavir - II lonafarnib 100 mg BID + ritonavir 50 mg BID for 12 weeks 0 None 0 4 4 4 View
Lonafarnib/Ritonavir - III lonafarnib 100 mg QD + ritonavir 100 mg QD for 12 weeks 0 None 3 5 5 5 View
Lonafarnib/Ritonavir - IV lonafarnib 150 mg QD + ritonavir 100 mg QD for 12 weeks 0 None 0 3 3 3 View
Lonafarnib/Ritonavir/PEG IFN-a - V lonafarnib 75 mg BID + ritonavir 100 mg BID; + PEG IFN-a 180 ug QW from Week 12-24 0 None 0 3 3 3 View
Lonafarnib/Ritonavir - VI lonafarnib 25 mg BID + ritonavir 100 mg BID for 24 weeks 0 None 0 6 6 6 View
Lonafarnib/Ritonavir - VII lonafarnib 50 mg BID + ritonavir 100 mg BID for 24 weeks 0 None 2 13 13 13 View
Lonafarnib/Ritonavir/PEG IFN-a - VIII lonafarnib 50 mg BID + ritonavir 100 mg BID; + PEG IFN-a 180 ug QW from Week 12-24 0 None 1 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
neuropathy vasculitis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
hepatic decompensation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
weight loss SYSTEMATIC_ASSESSMENT Investigations None View