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 @ 2:21 AM
Ignite Modification Date: 2025-12-26 @ 12:52 AM
NCT ID: NCT01523834
Description: We used the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE) for the coding of adverse events.
Frequency Threshold: 0
Time Frame: 6 years
Study: NCT01523834
Study Brief: Oral Panobinostat Adult Patients DLBCL Relapsed/Refractory Stem Cell Transfusion (ASCT) or Not Eligible for ASCT
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Panobinosat The treatment is divided in three phases: induction phase (course 1 to 6), consolidation phase (courses 7 to 12), maintenance phase (from course 13 until the end of therapy for any reason). The duration of a treatment course will be 28 days. The first dose of panobinostat in course 1 defines day 1 of the treatment cycle, and each cycle thereafter will begin 28 days later. Treatment: Panobinostat: Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy). Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle. The dose of panobinostat may be modified: the 1st dose adjustment consists in the modification of drug administration from 3 times every week (QW) to 3 times every other week (QOW). Levels lower than 30 mg 3 times QOW is not permitted. 29 None 12 35 8 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Acute renal injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Parossistic atrial fibrillation and congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.0 View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Subocclusive syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Nausea, vomit, diarrea, ipoK+, atc prolonged SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Paralysis of arms SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Aortic aneurysm rupture SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View