Adverse Events Module

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 @ 2:39 AM
Ignite Modification Date: 2025-12-26 @ 1:18 AM
NCT ID: NCT02396134
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 1 year post-transplant.
Study: NCT02396134
Study Brief: Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
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 II (Placebo) Patients receive placebo SC on days 28 and 56 after HCT. Placebo: Given SC Laboratory Biomarker Analysis: Correlative studies 4 None 7 29 26 29 View
Arm I (CMVpp65-A*0201 Peptide Vaccine) Patients receive CMVpp65-A\*0201 peptide vaccine SC on days 28 and 56 after HCT. CMVpp65-A\*0201 peptide vaccine: Given SC Laboratory Biomarker Analysis: Correlative studies 8 None 10 32 28 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemorrhagic cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
parainfluenza SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Worsening skin GVHD SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Hospitalization for worsening GVHD symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
CMV viremia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
negative rod bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Electrolyte derangements SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Cystitis noninfective SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Thrombotic thrombocytopenic purpura SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
progression to AML SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
heart palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (4.0) View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Mouth lesion/sore SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Malaise SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
lightheadedness SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
BK virus SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
C. Diff. infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
C. diff. SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
CMV viremia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Thrush SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
serratia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Iron overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Deconditioning SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
difficulty dosiflexing rt foot SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
joint discomfort & instability SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
shaking chills SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Bladder spasm SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Cystitis noninfective SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
bladder pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Acne Pustules SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Erythema at injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Pruritis at injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Skin lesions SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
CMV gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Esophageal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Mouth lesion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Pearly Papule on oral mucosa SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
mouth pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
mouth sores SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
umbilcal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Bleeding from hemorrhoids SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Difficulty tasting food SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema face SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Localized edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
soft tissue edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
hyperbilirubinemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Lesion on lip after biting lip SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View