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: 2025-12-24 @ 3:59 PM
Ignite Modification Date: 2025-12-25 @ 2:02 PM
NCT ID: NCT04348292
Description: None
Frequency Threshold: 0
Time Frame: adverse event data were collected from screening until surgical resection, an average of 12 weeks
Study: NCT04348292
Study Brief: Sirolimus and Durvalumab for the Treatment of Stage I-IIIA Non-small Cell Lung Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Sirolimus, Durvalumab) Patients receive sirolimus PO QD on days 1-21 in the absence of disease progression or unacceptable toxicity. Starting on day 22, patients receive durvalumab IV over 1 hour. Treatment with durvalumab repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Within a 2-3 week period after the second dose of durvalumab, but not earlier than two weeks after the administration of durvalumab, patients undergo standard of care surgery. Durvalumab: Given IV Sirolimus: Given PO 0 None 0 3 3 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
chyle leak NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
pulmonary fibrosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View