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: 2025-12-25 @ 2:26 AM
Ignite Modification Date: 2025-12-26 @ 12:59 AM
NCT ID: NCT00437034
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00437034
Study Brief: Aflibercept for Relapsed Multiple Myeloma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Antiangiogenesis Therapy) Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. aflibercept: Given IV None None 0 6 6 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough None Respiratory, thoracic and mediastinal disorders None View
Hypertension None Vascular disorders None View
Insomnia None Psychiatric disorders None View
Anemia None Blood and lymphatic system disorders None View
Dizziness None Nervous system disorders None View
ODYNOPHAGIA (PAINFUL SWALLOWING) None Gastrointestinal disorders None View
Voice changes None Respiratory, thoracic and mediastinal disorders None View
Rash: desquamation None Skin and subcutaneous tissue disorders None View
Pain: Muscle None Musculoskeletal and connective tissue disorders None View
Fatigue None General disorders None View
Diarrhea None Gastrointestinal disorders None View
Leukocytes decreased None Investigations None View
Anorexia None Gastrointestinal disorders None View
Ataxia None Nervous system disorders None View
Alkaline phosphatase increased None Investigations None View
Neutrophil count decreased None Investigations None View
Platelet count decreased None Investigations None View
Creatinine increased None Investigations None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Headache None Nervous system disorders None View
Hypocalcemia None Metabolism and nutrition disorders None View
Muscle weakness None Musculoskeletal and connective tissue disorders None View
Depression None Psychiatric disorders None View
Nasal cavity/paranasal sinus reactions None Respiratory, thoracic and mediastinal disorders None View