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 @ 2:13 AM
Ignite Modification Date: 2025-12-26 @ 12:42 AM
NCT ID: NCT00581360
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00581360
Study Brief: Phase II Trial of Doxorubicin and Bortezomib in Patients With Incurable Adenoid Cystic Carcinoma of the Head and Neck
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bortezomib + Doxorubicin Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin None None 3 9 9 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypotension None Cardiac disorders None View
Constipation None General disorders None View
Local complication -device/prosthesis-related None Musculoskeletal and connective tissue disorders None View
Pain, Abdomen NOS None General disorders None View
Pain, Chest/thorax NOS None General disorders None View
Dyspnea (shortness of breath) None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Allergic reaction/hypersensitivity (including drug fever) None Immune system disorders None View
Hemoglobin None Blood and lymphatic system disorders None View
Leukocytes (total WBC) None Blood and lymphatic system disorders None View
Neutrophils/granulocytes (ANC/AGC) None Blood and lymphatic system disorders None View
Platelets None Blood and lymphatic system disorders None View
Fatigue (asthenia, lethargy, malaise) None General disorders None View
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) None General disorders None View
Sweating (diaphoresis) None General disorders None View
Dermatology/Skin - Other (Specify, __) None Skin and subcutaneous tissue disorders None View
Dry skin None Skin and subcutaneous tissue disorders None View
Hair loss/alopecia (scalp or body) None Skin and subcutaneous tissue disorders None View
Rash/desquamation None Skin and subcutaneous tissue disorders None View
Rash: acne/acneiform None Skin and subcutaneous tissue disorders None View
Urticaria (hives, welts, wheals) None Skin and subcutaneous tissue disorders None View
Anorexia None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Dry mouth/salivary gland (xerostomia) None Gastrointestinal disorders None View
Dysphagia (difficulty swallowing) None Gastrointestinal disorders None View
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) None Gastrointestinal disorders None View
Mucositis/stomatitis (clinical exam), Oral cavity None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Hemorrhage, pulmonary/upper respiratory, Nose None Vascular disorders None View
Infection - Other (Specify, __) None Infections and infestations None View
Opportunistic infection associated with >=Grade 2 Lymphopenia None Infections and infestations None View
Edema: limb None Blood and lymphatic system disorders None View
ALT, SGPT (serum glutamic pyruvic transaminase) None Investigations None View
AST, SGOT(serum glutamic oxaloacetic transaminase) None Investigations None View
Magnesium, serum-low (hypomagnesemia) None Investigations None View
Potassium, serum-low (hypokalemia) None Investigations None View
Sodium, serum-low (hyponatremia) None Investigations None View
Dizziness None Nervous system disorders None View
Neuropathy: motor None Nervous system disorders None View
Neuropathy: sensory None Nervous system disorders None View
Ocular/Visual - Other (Specify, __) None Eye disorders None View
Watery eye (epiphora, tearing) None Eye disorders None View
Pain - Other (Specify, __) None General disorders None View
Pain, Abdomen NOS None General disorders None View
Pain, Chest wall None General disorders None View
Pain, Extremity-limb None General disorders None View
Pain, Head/headache None General disorders None View
Pain, Joint None General disorders None View
Pain, Pain NOS None General disorders None View
Obstruction/stenosis of airway, Bronchus None Respiratory, thoracic and mediastinal disorders None View
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) None Respiratory, thoracic and mediastinal disorders None View
Urine color change None Renal and urinary disorders None View