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 @ 3:23 PM
Ignite Modification Date: 2025-12-25 @ 1:41 PM
NCT ID: NCT00952692
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00952692
Study Brief: Study to Assess dHER2+AS15 Cancer Vaccine Given in Combination With Lapatinib to Patients With Metastatic Breast 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
dHER2 + AS15 ASCI + Lapatinib Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine. The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study. None None 2 12 11 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
pulmonary embolism SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
flu like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
neurosensory SYSTEMATIC_ASSESSMENT Nervous system disorders None View
neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dermatology/rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
balance/diziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuro-motor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
xerosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
injection site reactions SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hand foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vision change SYSTEMATIC_ASSESSMENT Eye disorders None View
infection (thumb) SYSTEMATIC_ASSESSMENT Infections and infestations None View
hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
fever/chills SYSTEMATIC_ASSESSMENT General disorders None View
change in voice SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View