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: 2025-12-25 @ 4:06 AM
Ignite Modification Date: 2025-12-26 @ 3:03 AM
NCT ID: NCT00602420
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00602420
Study Brief: Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days. placebo: Oral placebo twice daily for 5-8 days. None None 3 253 3 253 View
Naproxen Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days. naproxen: Oral naproxen twice daily for 5-8 days. None None 5 257 4 257 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.0 View
Anaphylactic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10.0 View
Acute pain secondary to marrow expansion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Hospitalized d/t NV, Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Neutropenic fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Supraventricular tachycardia (SVT); Rash NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Infection - right breast w/ cellulitis, normal ANC NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View