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 @ 4:36 AM
Ignite Modification Date: 2025-12-26 @ 3:38 AM
NCT ID: NCT03574818
Description: None
Frequency Threshold: 0
Time Frame: neoadjuvant treatment period - up to 63 days
Study: NCT03574818
Study Brief: Necitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable - 14X-US-I001
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1 Chemotherapy and Necitumumab Regimen Gemcitabine 1250mg/m2 IV over 30 minutes, days 1 and 8 following necitumumab, Cisplatin 75mg/m2 IV over 60 minutes, day 1, immediately following gemcitabine,each cycle is 3 weeks (21 days). Necitumumab 800mg absolute dose IV over a minimum of 60 minutes, days 1 and 8 prior to chemotherapy regimen Each cycle is 3 weeks (21 days). The regimen will be given for a total of 3 cycles. The regimen will be given for a total of 3 cycles. Necitumumab-Gemcitabine-Cisplatin: / Gemcitabine 1250mg/m2 IV on D1, D8 * Cisplatin 75mg / m2 IV on D1 * Necitumumab 800mg IV on D1, D8 (peripheral blood for effector cells and cytokine measurements prior to each cycle) Repeat cycle every 21 days up to 3 cycles. 0 None 0 1 1 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hypomagnesemia SYSTEMATIC_ASSESSMENT Investigations None View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View