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 @ 10:32 PM
Ignite Modification Date: 2025-12-25 @ 8:05 PM
NCT ID: NCT01559935
Description: Collection of adverse events is ongoing as 28 participants are still on trial. For the Car Phase, every adverse event not present at baseline was reported. For the BiRD and Maintenance phases, adverse events were only reported if it was a new occurrence (not present in the previous phase) or if the grade of the event increased. Grading was done using the CTCAE 4.0.
Frequency Threshold: 5
Time Frame: None
Study: NCT01559935
Study Brief: Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Therapy for Subjects With Multiple Myeloma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Car-BiRD Therapy Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\] Car Phase: carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib. BiRD Phase: Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Maintenance Phase: Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed. 1 None 26 72 72 72 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
spinal cord compression SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
creatinine increase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
secondary malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
fever SYSTEMATIC_ASSESSMENT Vascular disorders None View
abnominal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
URI SYSTEMATIC_ASSESSMENT Infections and infestations None View
UTI SYSTEMATIC_ASSESSMENT Infections and infestations None View
femur fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
spinal fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
atrial fibrilation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
massive heart attack SYSTEMATIC_ASSESSMENT Cardiac disorders None View
syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
surgical procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
increased creatinine SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
confusion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
non-cardiac chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
abdominal pain (small intestinal obstruction) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
non-cardiac chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
acute kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
enterocolitis infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
cardiac chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyperhidrosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
elevated ALT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
concentration impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
edema SYSTEMATIC_ASSESSMENT Vascular disorders None View
sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
URI SYSTEMATIC_ASSESSMENT Infections and infestations None View
diarhhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
pain in foot SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ear infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarhhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
flatulance SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyperbilirubinemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
elevated AST SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
elevated alkaline phosphatase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
increased creatinine SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
insomnia SYSTEMATIC_ASSESSMENT General disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
chills SYSTEMATIC_ASSESSMENT General disorders None View
peripheral neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
anxiety/stress SYSTEMATIC_ASSESSMENT Nervous system disorders None View
depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
dizziness / lightheaded SYSTEMATIC_ASSESSMENT Nervous system disorders None View
paresthesias SYSTEMATIC_ASSESSMENT Nervous system disorders None View
forgetful SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
irritability SYSTEMATIC_ASSESSMENT Nervous system disorders None View
agitation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
fever SYSTEMATIC_ASSESSMENT Vascular disorders None View
muscle spasms/cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
pain in legs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
lower extremity pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
high BNP SYSTEMATIC_ASSESSMENT Cardiac disorders None View
low eGFR SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
genitourinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
UTI SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
flatulance SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
elevated ALT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
ALK increase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
increased creatinine SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
insomnia SYSTEMATIC_ASSESSMENT General disorders None View
malaise SYSTEMATIC_ASSESSMENT General disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
peripheral neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dizziness / lightheaded SYSTEMATIC_ASSESSMENT Nervous system disorders None View
parethesias SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
irritability SYSTEMATIC_ASSESSMENT Nervous system disorders None View
edema SYSTEMATIC_ASSESSMENT Vascular disorders None View
cushingoid appearance SYSTEMATIC_ASSESSMENT Vascular disorders None View
muscle spasms/cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
low eGFR SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
lung infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarhhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
flatulance SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyperbilirubinemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
elevated ALT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
elevated AST SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
increased creatinine SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
hair loss SYSTEMATIC_ASSESSMENT General disorders None View
peripheral neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
anxiety/stress SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
dizziness / lightheaded SYSTEMATIC_ASSESSMENT Nervous system disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
edema SYSTEMATIC_ASSESSMENT Vascular disorders None View
hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
muscle spasms/cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
rib pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
chest pain (muscular) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
pain in legs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
arthralgias SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
lower extremity pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
upper extremity pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
skin darknening SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
blurry vision SYSTEMATIC_ASSESSMENT Eye disorders None View
bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
genitourinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
lung infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
URI SYSTEMATIC_ASSESSMENT Infections and infestations None View
skin Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View