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 @ 11:28 PM
Ignite Modification Date: 2025-12-25 @ 9:15 PM
NCT ID: NCT01444456
Description: Only adverse drug reactions to Amgen products were collected in this study. The table of Other Adverse Events summarizes non-serious occurrences of adverse drug reactions.
Frequency Threshold: 0
Time Frame: Up to 28 days after a participant's last dose date, capped at 17 weeks
Study: NCT01444456
Study Brief: Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Darbepoetin Alfa or Other ESA Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice. None None 2 1158 8 1158 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.1 View
Cystoid macular oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View