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 @ 12:38 AM
Ignite Modification Date: 2025-12-25 @ 10:48 PM
NCT ID: NCT00679367
Description: Toxicity data was collected throughout study participation through 30 days after last dose.
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT00679367
Study Brief: Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Melphalan Revlimid and Dexamethasone Melphalan Lenalidomide Dexamethasone dexamethasone: 40 mg once weekly lenalidomide: 10 mg/day Days 1-21 melphalan: 5 mg/m2 Days 1-4 None None 16 16 16 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
thromboembolism SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
pleural effusion - bilateral SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Elevated blood urea nitrogen test SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
chest pressure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
gastrointestinal bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
gout pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
septic shock SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
tear duct obstruction/infection SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
increased creatinine SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
hyponatremia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
hyperglycemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
abdominal bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
abdominal cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
altered taste SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
aspiration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
blurring SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
cold intolerance SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
decreased bilirubin SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
decreased iron SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
decreased performance status SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
decreased renal function SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
early satiety SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
bruising SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
edema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
flatus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
gout SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (3.0) View
double vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
hemorrhoida SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
hip fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
hyperglycemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
hyperkalemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
hypermagnesemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
hypernatremia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
hyperphosphatemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (3.0) View
hyperuricemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
hypoalbuminemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
hypocalcemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
hypokalemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
hypomagnesemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
hyponatremia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
hypotension SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
increased alkaline phosphatate SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
increased Brain natriuretic peptide SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
increased creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
insomnia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
itchy eyes SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
mental disturbance SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
mouth sores SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
muscle cramping SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
peripheral neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
nocturia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
polydipsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
sweats SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE (3.0) View
infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
tremors SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
unsteady gait SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
infection - upper respiratory SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
infection - urinary tract SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
weakness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
weight loss SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View