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 @ 1:34 AM
Ignite Modification Date: 2025-12-25 @ 11:47 PM
NCT ID: NCT00337194
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00337194
Study Brief: SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin 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
Arm I (SGN-30, Chemotherapy) Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days. No prior stem cell transplant: SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8. Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8. monoclonal antibody SGN-30: Given IV vinorelbine tartrate: Given IV pegylated liposomal doxorubicin hydrochloride: Given IV gemcitabine hydrochloride: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies None None 9 23 21 23 View
Arm II (Placebo, Chemotherapy) Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days. No prior stem cell transplant: SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 20 mg/m\^2 IV days 1 \& 8, gemcitabine: 1000 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 \& 8. Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 \& 8, vinorelbine: 15 mg/m\^2 IV days 1 \& 8, gemcitabine: 800 mg/m\^2 IV days 1 \& 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 \& 8. placebo: Given IV vinorelbine tartrate: Given IV pegylated liposomal doxorubicin hydrochloride: Given IV gemcitabine hydrochloride: Given IV laboratory biomarker analysis: Correlative studies pharma None None 1 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Visceral edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
INR increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Laboratory test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum glucose decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum magnesium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum magnesium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum phosphate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Chylothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Body odor SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Hand-and-foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Photosensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Cardiac pain SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Edema SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Joint- Late RT Morbidity Scoring SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Visceral edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 6 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Upper aerodigestive tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Coagulopathy SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
INR increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum magnesium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum potassium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum sodium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Joint disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Laryngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Hand-and-foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View