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: 2025-12-26 @ 10:57 AM
Ignite Modification Date: 2025-12-26 @ 10:57 AM
NCT ID: NCT00715208
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00715208
Study Brief: Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
VELCADE R-CAP VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin None None 2 7 7 7 View
VELCADE R-CP VELCADE, rituximab, cyclophosphamide, and prednisone None None 12 48 47 48 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchitis NOS None Infections and infestations None View
Bronchitis acute NOS None Infections and infestations None View
Pneumonia NOS None Infections and infestations None View
Bacteraemia None Infections and infestations None View
Neutropenic sepsis None Infections and infestations None View
Oropharyngeal candidiasis None Infections and infestations None View
Respiratory tract infection NOS None Infections and infestations None View
Cellulitis None Infections and infestations None View
Viral infection NOS None Infections and infestations None View
Pyrexia None General disorders None View
Fatigue None General disorders None View
Weakness None General disorders None View
Febrile neutropenia None Blood and lymphatic system disorders None View
Neutropenia None Blood and lymphatic system disorders None View
Lymphadenopathy None Blood and lymphatic system disorders None View
Leukopenia NOS None Blood and lymphatic system disorders None View
Dyspnoea NOS None Respiratory, thoracic and mediastinal disorders None View
Chronic obstructive airways disease exacerbated None Respiratory, thoracic and mediastinal disorders None View
Lung infiltration NOS None Respiratory, thoracic and mediastinal disorders None View
Pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Respiratory failure (excl neonatal) None Respiratory, thoracic and mediastinal disorders None View
Cardiac failure congestive None Cardiac disorders None View
Myocardial infarction None Cardiac disorders None View
Atrial fibrillation None Cardiac disorders None View
Ascites None Gastrointestinal disorders None View
Abdominal pain NOS None Gastrointestinal disorders None View
Blood culture positive None Investigations None View
Electrocardiogram T wave abnormal None Investigations None View
Back pain None Musculoskeletal and connective tissue disorders None View
Pain in limb None Musculoskeletal and connective tissue disorders None View
Syncope None Nervous system disorders None View
Headache NOS None Nervous system disorders None View
Vision blurred None Eye disorders None View
Hypertension aggravated None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting NOS None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Stomatitis None Gastrointestinal disorders None View
Pharyngolaryngeal pain None Gastrointestinal disorders None View
Alopecia None Skin and subcutaneous tissue disorders None View
Night sweats None Skin and subcutaneous tissue disorders None View
Dry skin None Skin and subcutaneous tissue disorders None View
Skin lesion NOS None Skin and subcutaneous tissue disorders None View
Skin hypopigmentation None Skin and subcutaneous tissue disorders None View
Nail disorder None Skin and subcutaneous tissue disorders None View
Palmar-plantar erythrodysaesthesia syndrome None Skin and subcutaneous tissue disorders None View
Rigors None General disorders None View
Oedema lower limb None General disorders None View
Fatigue aggravated None General disorders None View
Infusion associated symptoms None General disorders None View
Fall None General disorders None View
Chest pain None General disorders None View
Anorexia None Metabolism and nutrition disorders None View
Dehydration None Metabolism and nutrition disorders None View
Hypocalcaemia None Metabolism and nutrition disorders None View
Hyperglycaemia NOS None Metabolism and nutrition disorders None View
Hypokalaemia None Metabolism and nutrition disorders None View
Hyponatraemia None Metabolism and nutrition disorders None View
Hyperuricaemia None Metabolism and nutrition disorders None View
Anaemia None Blood and lymphatic system disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Lymphopenia None Blood and lymphatic system disorders None View
Peripheral neuropathy NOS None Nervous system disorders None View
Peripheral sensory neuropathy None Nervous system disorders None View
Peripheral neuropathy aggravated None Nervous system disorders None View
Dizziness (excl vertigo) None Nervous system disorders None View
Dysgeusia None Nervous system disorders None View
Paraesthesia None Nervous system disorders None View
Restless leg syndrome None Nervous system disorders None View
Upper respiratory tract infection NOS None Infections and infestations None View
Herpes zoster None Infections and infestations None View
Urinary tract infection NOS None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Rhinitis NOS None Respiratory, thoracic and mediastinal disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Pulmonary congestion None Respiratory, thoracic and mediastinal disorders None View
Musculoskeletal pain None Musculoskeletal and connective tissue disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Bone pain None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Muscle cramps None Musculoskeletal and connective tissue disorders None View
Peripheral swelling None Musculoskeletal and connective tissue disorders None View
White blood cell count decreased None Investigations None View
Lymphocyte count decreased None Investigations None View
Neutrophil count decreased None Investigations None View
Haemoglobin decreased None Investigations None View
Blood uric acid increased None Investigations None View
Platelet count decreased None Investigations None View
Blood glucose increased None Investigations None View
Blood urea increased None Investigations None View
Blood creatinine increased None Investigations None View
Insomnia None Psychiatric disorders None View
Confusion None Psychiatric disorders None View
Hypotension NOS None Vascular disorders None View
Flushing None Vascular disorders None View
Lacrimation increased None Eye disorders None View
Eye irritation None Eye disorders None View
Tachycardia NOS None Cardiac disorders None View
Sinus Tachycardia None Cardiac disorders None View
Ventricular hypokinesia None Cardiac disorders None View
Renal failure acute None Renal and urinary disorders None View
Tinnitus None Ear and labyrinth disorders None View
Hypoproteinaemia None Hepatobiliary disorders None View
Hypersensitivity NOS None Immune system disorders None View
Breast discomfort None Reproductive system and breast disorders None View