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 @ 2:48 PM
Ignite Modification Date: 2025-12-25 @ 1:16 PM
NCT ID: NCT01716559
Description: An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Frequency Threshold: 1
Time Frame: Up to Week 16
Study: NCT01716559
Study Brief: An Observational Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Non-myeloid Malignancy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Epoetin Beta Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed. None None 25 160 11 160 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia haemolytic autoimmune SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Bone marrow failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Granulocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Idiopathic thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.0 View
Brain abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Plasma cell myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Granulocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Granulocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.0 View
Metastasis to Bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View