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S0522 Induction and Consolidation Adverse Event Summary Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0F6E276E-AFFB-31C9-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0F6E276E-AFFB-31C9-E044-0003BA3F9857

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Creative Commons BY-NC 3.0 Legacy

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Multiple Myeloma and Plasma Cell Neoplasm null Toxicity - S0522 Induction and Consolidation Adverse Event Summary Form - 2463018v1.0

model
Details

No Instruction available.

1 Formulieren

StudyEvent: S0522 Induction and Consolidation Adverse Event Summary Form
1. No Instruction available.

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Unnamed1

Item Group

Unnamed1

PatientSouthwestOncologyGroupIdentifierNumber

Item

SWOG Patient ID

double

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)

ProtocolSWOGIdentifierNumber

Item

SWOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)

RegistrationStepNumber

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)

PatientInitialsName

Item

Patient Initials (L, F M)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)

TreatmentCycleCompleteName

Item

Cycle completed

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25472 (NCI Thesaurus ObjectClass)
C1511572 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)

CL.1

Code List

Cycle completed

CL Item

Induction (Induction)

CL042203 (NCI Metathesaurus)

CL Item

Consolidation (Consolidation)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

RegisteredInvestigatorName

Item

Physician

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus ObjectClass)

ParticipatingGroupName

Item

Participating Group Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolParticipatingIdentifierNumber

Item

Participating Group Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ADVERSE EVENTS1

Item Group

Adverse Events1

TreatmentReportingPeriodBeginDate

Item

Reporting Period Start Date

date

C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

AdverseEventMostRecentAssessmentDate

Item

Date of Most Recent Adverse Event Assessment

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus Property)
C1513491 (UMLS 2011AA Property)

AdverseEventCurrentAssessmentInd

Item

Were adverse events assessed during this time period

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)

CL.2

Code List

Were adverse events assessed during this time period

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes, But No Reportable Adverse Events Occurred (Yes, but no reportable adverse events occurred)

CL Item

Yes, And Reportable Adverse Events Occurred (Yes, and reportable adverse events occurred)

CTC Adverse Event Term

Item Group

Ctc Adverse Event Term

CommonToxicityCriteriaAdverseEventTermType

Item

CTC Adverse Event Term

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)

CL.3

Code List

CTC Adverse Event Term

CL Item

Rhinitis Allergic Nos (Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip))

C0002103 (NCI Metathesaurus)

CL Item

Vasculitis Nos (Vasculitis)

CL Item

Tinnitus (Tinnitus)

C50772 (NCI Thesaurus)
C0040264 (UMLS 2011AA)

CL Item

Haemoglobin Decreased (Hemoglobin)

C0162119 (NCI Metathesaurus)

CL Item

Leucopenia Nos (Leukocytes (total WBC))

CL Item

Neutropenia (Neutrophils/granulocytes (ANC/AGC))

C3277 (NCI Thesaurus)

CL Item

Platelet Count Decreased (Platelets)

C0392386 (NCI Metathesaurus)

CL Item

Sinus Bradycardia (Supraventricular and nodal arrhythmia - Sinus bradycardia)

C26923 (NCI Thesaurus)
C0085610 (UMLS 2011AA)

CL Item

Hypertension Nos (Hypertension)

CL Item

Hypotension Nos (Hypotension)

CL Item

Pericardial Effusion (Pericardial effusion (non-malignant))

C3319 (NCI Thesaurus)
C0031039 (UMLS 2011AA)

CL Item

Fatigue (Fatigue (asthenia, lethargy, malaise))

C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)

CL Item

Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L))

CL Item

Insomnia Nec (Insomnia)

CL Item

Rigors (Rigors/chills)

C0424790 (NCI Metathesaurus)

CL Item

Weight Decreased (Weight loss)

CL Item

Dry Skin (Dry skin)

C0151908 (NCI Metathesaurus)

CL Item

Flushing (Flushing)

C26775 (NCI Thesaurus)
C0016382 (UMLS 2011AA)

CL Item

Injection Site Reaction Nos (Injection site reaction/extravasation changes)

CL Item

Pruritus Nos (Pruritus/itching)

CL Item

Dermatitis Exfoliative Nos (Rash/desquamation)

CL Item

Erythema Multiforme (Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis))

C3024 (NCI Thesaurus)
C0014742 (UMLS 2011AA)

CL Item

Urticaria Nos (Urticaria (hives, welts, wheals))

CL Item

Hypothyroidism (Thyroid function, low (hypothyroidism))

C26800 (NCI Thesaurus)
C0020676 (UMLS 2011AA)

CL Item

Anorexia (Anorexia)

C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)

CL Item

Constipation (Constipation)

C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)

CL Item

Dehydration (Dehydration)

C26740 (NCI Thesaurus)
C0011175 (UMLS 2011AA)

CL Item

Diarrhoea Nos (Diarrhea)

CL Item

Dry Mouth (Dry mouth/salivary gland (xerostomia))

C26917 (NCI Thesaurus)
C0043352 (UMLS 2011AA)

CL Item

Oesophagitis Nos (Esophagitis)

CL Item

Flatulence (Flatulence)

C37954 (NCI Thesaurus)
C0016204 (UMLS 2011AA)

CL Item

Dyspepsia (Heartburn/dyspepsia)

C26756 (NCI Thesaurus)
C0013395 (UMLS 2011AA)

CL Item

Ileus (Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation))

C37979 (NCI Thesaurus)
C1258215 (UMLS 2011AA)

CL Item

Nausea (Nausea)

C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)

CL Item

Taste Disturbance (Taste alteration (dysgeusia))

CL Item

Vomiting Nos (Vomiting)

CL Item

Haemorrhagic Stroke (Hemorrhage, CNS)

CL036983 (NCI Metathesaurus)

CL Item

Pancreatitis Nos (Pancreatitis)

CL Item

Edema: Head And Neck (Edema: head and neck)

CL Item

Oedema Nos (Edema: limb)

CL Item

Alanine Aminotransferase Increased (ALT, SGPT (serum glutamic pyruvic transaminase))

C26948 (NCI Thesaurus)
C0151905 (UMLS 2011AA)

CL Item

Aspartate Aminotransferase Increased (AST, SGOT (serum glutamic oxaloacetic transaminase))

C26947 (NCI Thesaurus)
C0151904 (UMLS 2011AA)

CL Item

Blood Alkaline Phosphatase Nos Increased (Alkaline phosphatase)

CL Item

Hypercalcaemia (Calcium, serum-high (hypercalcemia))

CL Item

Hypocalcaemia (Calcium, serum-low (hypocalcemia))

CL Item

Blood Creatinine Increased (Creatinine)

C0235431 (NCI Metathesaurus)

CL Item

Gamma-glutamyltransferase Increased (GGT (gamma-glutamyl transpeptidase))

C26943 (NCI Thesaurus)
C0151662 (UMLS 2011AA)

CL Item

Hyperglycaemia Nos (Glucose, serum-high (hyperglycemia))

CL Item

Hypoglycaemia Nos (Glucose, serum-low (hypoglycemia))

CL Item

Blood Magnesium Decreased (Magnesium, serum-low (hypomagnesemia))

CL039365 (NCI Metathesaurus)

CL Item

Hypophosphataemia (Phosphate, serum-low (hypophosphatemia))

C0085682 (NCI Metathesaurus)

CL Item

Extremity-lower (gait/walking) (Extremity-lower (gait/walking))

CL Item

Muscle Weakness Nos (Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized)

C0151786 (NCI Metathesaurus)

CL Item

Osteonecrosis (Osteonecrosis (avascular necrosis))

CL Item

Osteoporosis (Osteoporosis)

C3298 (NCI Thesaurus)
C0029456 (UMLS 2011AA)

CL Item

Cerebral Ischaemia (CNS cerebrovascular ischemia)

C0917798 (NCI Metathesaurus)

CL Item

Confusion (Confusion)

C37928 (NCI Thesaurus)
C0009676 (UMLS 2011AA)

CL Item

Dizziness (exc Vertigo) (Dizziness)

CL Item

Anxiety Nec (Mood alteration - anxiety)

CL Item

Depression Nec (Mood alteration - depression)

CL Item

Euphoric Mood (Mood alteration - euphoria)

C27011 (NCI Thesaurus)
C0235146 (UMLS 2011AA)

CL Item

Peripheral Motor Neuropathy (Neuropathy: motor)

C3500 (NCI Thesaurus)
C0018995 (UMLS 2011AA)

CL Item

Peripheral Sensory Neuropathy (Neuropathy: sensory)

C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)

CL Item

Delusion Nos (Psychosis (hallucinations/delusions))

CL Item

Convulsions Nos (Seizure)

CL Item

Depressed Level Of Consciousness (Somnolence/depressed level of consciousness)

C0549249 (NCI Metathesaurus)

CL Item

Syncope (Syncope (fainting))

C35053 (NCI Thesaurus)
C0039070 (UMLS 2011AA)

CL Item

Tremor Nec (Tremor)

CL Item

Dry Eye Nec (Dry eye syndrome)

CL Item

Diplopia (Ophthalmoplegia/diplopia (double vision))

C37941 (NCI Thesaurus)
C0012569 (UMLS 2011AA)

CL Item

Vision Blurred (Vision-blurred vision)

CL Item

Cough (Cough)

C37935 (NCI Thesaurus)
C0010200 (UMLS 2011AA)

CL Item

Dyspnoea Nos (Dyspnea (shortness of breath))

CL Item

Nasal Cavity/paranasal Sinus Reactions (Nasal cavity/paranasal sinus reactions)

CL Item

Pleural Effusion (Pleural effusion (non-malignant))

C3331 (NCI Thesaurus)
C0021071 (UMLS 2011AA)

CL Item

Sexual/reproductive Function Other (Sexual/Reproductive Function-Other (Specify))

CL Item

Peripheral Ischaemia Nos (Peripheral arterial ischemia)

CL Item

Thrombosis/embolism (vascular Access-related) (Thrombosis/embolism (vascular access-related))

CommonToxicityCriteriaAdverseEventOtherReproductiveFunctionSpecify

Item

Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0232896 (NCI Metathesaurus Property)

ADVERSE EVENTS2

Item Group

Adverse Events

CTCAdverseEventTermSpecify

Item

CTC Adverse Event Term, Other (specify using CTCAE 3.0 terminology)

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)

CommonToxicityCriteriaAdverseEventGrade

Item

CTCAE (3.0) Grade (1 - 5)

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.6

Code List

CTCAE (3.0) Grade (1 - 5)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

CL Item

Mild Adverse Event (1)

C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)

CL Item

Moderate Adverse Event (2)

C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)

CL Item

Life-threatening Or Disabling Adverse Event (4)

CL Item

Severe Adverse Event (3)

C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)

CommonToxicityCriteriaAdverseEventGrade

Item

CTCAE (3.0) Grade (1 - 5)

double

CL.6

Code List

CTCAE (3.0) Grade (1 - 5)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

CL Item

Mild Adverse Event (1)

C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)

CL Item

Moderate Adverse Event (2)

C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)

CL Item

Life-threatening Or Disabling Adverse Event (4)

CL Item

Severe Adverse Event (3)

C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)

CTCAdverseEventAttributionScale

Item

CTC Adverse Event Attribution Code (*)

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)

CL.7

Code List

CTC Adverse Event Attribution Code (*)

CL Item

Unrelated (unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

CL Item

Unlikely (unlikely)

CL Item

Possible (possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (probable)

C0332148 (NCI Metathesaurus)

CL Item

Definite (definite)

CL209464 (NCI Metathesaurus)

CTCAdverseEventAttributionScale

Item

CTC Adverse Event Attribution Code (*)

text

CL.7

Code List

CTC Adverse Event Attribution Code (*)

CL Item

Unrelated (unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

CL Item

Unlikely (unlikely)

CL Item

Possible (possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (probable)

C0332148 (NCI Metathesaurus)

CL Item

Definite (definite)

CL209464 (NCI Metathesaurus)

Comments

Item Group

Comments

ResearchCommentsText

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

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Multiple Myeloma and Plasma Cell Neoplasm null Toxicity - S0522 Induction and Consolidation Adverse Event Summary Form - 2463018v1.0

No Instruction available.

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