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 @ 7:23 PM
Ignite Modification Date: 2025-12-25 @ 5:03 PM
NCT ID: NCT00302003
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00302003
Study Brief: Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's 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
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 \& 2, Vincristine sulfate IV (1.4 mg/m2 \[max 2.8 mg\]) Days 1 \& 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 \& 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy. radiation therapy: Undergo radiation therapy doxorubicin hydrochloride: Given IV vincristine sulfate: Given IV prednisone: Given orally cyclophosphamide: Given IV ifosfamide: Given IV vinorelbine tartrate: Given IV dexamethasone: Given IV etoposide phosphate: Given IV cisplatin: Given IV cytarabine: Given IV filgrastim: Given IV or subcutaneously None None 2 278 80 278 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infections and infestations - Other, specify None Infections and infestations None View
CPK increased None Investigations None View
Acidosis None Metabolism and nutrition disorders None View
Thromboembolic event None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Febrile neutropenia None Blood and lymphatic system disorders None View
Hearing impaired None Ear and labyrinth disorders None View
Tinnitus None Ear and labyrinth disorders None View
Delayed puberty None Endocrine disorders None View
Hypothyroidism None Endocrine disorders None View
Eye pain None Eye disorders None View
Optic nerve disorder None Eye disorders None View
Abdominal pain None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Enterocolitis None Gastrointestinal disorders None View
Esophageal pain None Gastrointestinal disorders None View
Esophagitis None Gastrointestinal disorders None View
Ileus None Gastrointestinal disorders None View
Mucositis oral None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Oral pain None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Fatigue None General disorders None View
Pain None General disorders None View
Anaphylaxis None Immune system disorders None View
Bladder infection None Infections and infestations None View
Catheter related infection None Infections and infestations None View
Infections and infestations - Other, specify None Infections and infestations None View
Lung infection None Infections and infestations None View
Skin infection None Infections and infestations None View
Soft tissue infection None Infections and infestations None View
Tracheitis None Infections and infestations None View
Upper respiratory infection None Infections and infestations None View
Vascular access complication None Injury, poisoning and procedural complications None View
Alanine aminotransferase increased None Investigations None View
Aspartate aminotransferase increased None Investigations None View
Lymphocyte count decreased None Investigations None View
Neutrophil count decreased None Investigations None View
Platelet count decreased None Investigations None View
White blood cell decreased None Investigations None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hyperkalemia None Metabolism and nutrition disorders None View
Hypermagnesemia None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Bone pain None Musculoskeletal and connective tissue disorders None View
Generalized muscle weakness None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View
Neuralgia None Nervous system disorders None View
Peripheral motor neuropathy None Nervous system disorders None View
Peripheral sensory neuropathy None Nervous system disorders None View
Syncope None Nervous system disorders None View
Vasovagal reaction None Nervous system disorders None View
Agitation None Psychiatric disorders None View
Anxiety None Psychiatric disorders None View
Depression None Psychiatric disorders None View
Insomnia None Psychiatric disorders None View
Bronchospasm None Respiratory, thoracic and mediastinal disorders None View
Pharyngeal mucositis None Respiratory, thoracic and mediastinal disorders None View
Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders None View
Rash maculo-papular None Skin and subcutaneous tissue disorders None View
Hypotension None Vascular disorders None View
Thromboembolic event None Vascular disorders None View