Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 6:42 PM
Ignite Modification Date: 2025-12-25 @ 4:13 PM
NCT ID: NCT00475657
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00475657
Study Brief: Pemetrexed and Cisplatin as Treatment in 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
Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles None None 2 None 5 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood creatine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Inappropriate antidiuretic hormone secretion SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.1 View