MedDRA AE Code (CTCAE v3.0) (Code used to identify the adverse event using a standard mechanism that facilitates analysis. CTEP¿s code list and associated Category/Term is currently a standard.)
Description
MedDRAAdverseEventCode
Data type
double
Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass
C43820
UMLS 2011AA ObjectClass
C1140263
NCI Thesaurus Property
C25162
UMLS 2011AA Property
C0805701
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain
C43820
UMLS 2011AA ValueDomain
C1140263
AE Attribution (This question is not asked for baseline assessments. Question should be asked mandatory for all studies that involve drug therapy.)
Description
CTCAdverseEventAttributionScale
Data type
text
Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Reporting Period End Date (End of the assessment period.)
Description
AdverseEventFinalAssessmentDate
Data type
date
Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25217
UMLS 2011AA Property
C1516048
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25508
UMLS 2011AA Property
C0205088
Were adverse events assessed during most recent period (Indicator to clarify whether any AEs were identified during the - reporting period. This is confirmation that the remainder of the form was intentionally left blank.)
Description
AdverseEventMostRecentAssessmentInd-3
Data type
text
Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25577
UMLS 2011AA Property
C1513491
Expected? (Yes/No)
Description
AdverseEventExpectedIndicator
Data type
text
Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25501
UMLS 2011AA Property
C1517001
Serious? (If a 'yes' response is entered, complete the SAE section for - this AE.)
Description
SeriousAdverseEventIndicator
Data type
text
Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Metathesaurus Property
CL124429
Event Onset Time (Enter the time of day when AE was first evident. Used when Date of Onset is insufficient.)
Description
AdverseEventOnsetTime
Data type
time
Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ValueDomain
C25207
UMLS 2011AA ValueDomain
C0040223
NCI Thesaurus Property
C25279
UMLS 2011AA Property
C0332162
Course (May be used during protocol therapy period to automatically - set the evaluation start/end dates to the period of the course of treatment e.g. user supplies course# and evaluation period derived.)
Description
ProtocolCourseNumberCount
Data type
double
Alias
NCI Thesaurus Property
C25337
UMLS 2011AA Property
C0237753
NCI Thesaurus ObjectClass
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C25379
UMLS 2011AA ObjectClass
C0750729
AE Evaluation Period Start Date (Date of the beginning start of the assessment period.)
Description
AdverseEventBeginAssessmentDate
Data type
date
Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
Pre-existing AE? (Should be derivable if you capture AEs for specified periods; not needed if you track an AE until it resolves including worseningrather than for a defined assessment period.)
Description
AdverseEventPre-ExistingIndicator
Data type
text
Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C73621
UMLS 2011AA Property
C2347662
AE Resolved Time (Enter the time of day when AE was resolved.)
Description
AdverseEventResolutionTime
Data type
time
Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ValueDomain
C25207
UMLS 2011AA ValueDomain
C0040223
NCI Thesaurus Property
C25655
UMLS 2011AA Property
C1514893
AE Ongoing? (Flag to indicate whether AE has resolved or not. This ensures that leaving 'Stop Date' blank was not done inadvertently.)
Description
AdverseEventOngoingEventIndicator
Data type
text
Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25499
UMLS 2011AA Property
C0441471
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Metathesaurus Property
CL259742
Participant Status/Outcome
Description
AdverseEventOutcomeType
Data type
text
Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C49489
UMLS 2011AA ValueDomain
C1705586
Adverse Event Condition Pattern (This should be derivable from a review of AEs over time.)
Description
AdverseEventConditionPattern
Data type
text
Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25457
UMLS 2011AA Property
C0348080
Did event reappear after study agent was reintroduced? (Enter response from choice list.)
Description
AdverseEventReappearanceIndicator
Data type
text
Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Metathesaurus Property
C0034897
NCI Metathesaurus ValueDomain
C0021212
Comments (A general comment that should not be specific to a single AE.)
Adverse Event Name (v3.0) (Code used to identify the adverse event using a standard mechanism that facilitates analysis. CTEP's code list and associated Category/Term is currently a standard. )
Adverse Event Name (v3.0) (Code used to identify the adverse event using a standard mechanism that facilitates analysis. CTEP's code list and associated Category/Term is currently a standard. )
CL Item
Acidosis Nos (Acidosis (metabolic or respiratory))
Conduction Abnormality/atrioventricular Heart Block - Av Block-second Degree Mobitz Type I (wenckebach) (Conduction abnormality/Atrioventricular heart block - AV block-Second degree Mobitz Type I (Wenckebach))
CL Item
Conduction Abnormality/atrioventricular Heart Block (Conduction abnormality/Atrioventricular heart block - AV block-second degree Mobitz Type II)
CL Item
Conduction Abnormality/atrioventricular Heart Block (Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block))
Febrile Neutropenia (fever Of Unknown Origin Without Clinically Or Microbiologically Documented Infection) (anc <1.0 X 10^9/l, Fever >=38.5 Degrees C) (Febrile neutropenia)
CL Item
Feminization (Feminization of male)
C26773 (NCI Thesaurus) C0015799 (UMLS 2011AA)
CL Item
Forced Expiratory Volume Decreased (FEV(1))
CL036765 (NCI Metathesaurus)
CL Item
Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L))
Hyperglycaemia Nos (Glucose, serum-high (hyperglycemia))
CL Item
Hypoglycaemia Nos (Glucose, serum-low (hypoglycemia))
CL Item
Growth And Development Other (Growth and Development-Other (Specify))
CL Item
Growth Velocity (reduction In Growth Velocity) (Growth velocity (reduction in growth velocity))
CL Item
Gynaecomastia (Gynecomastia)
CL Item
Alopecia (Hair loss/Alopecia (scalp or body))
C2865 (NCI Thesaurus)
CL Item
Haptoglobin Decreased (Haptoglobin)
C0236062 (NCI Metathesaurus)
CL Item
Hearing: Patients With/without Baseline Audiogram And Enrolled In A Monitoring Program (Hearing: patients with/without baseline audiogram and enrolled in a monitoring program)
CL Item
Hearing: Patients Without Baseline Audiogram And Not Enrolled In A Monitoring Program (Hearing: patients without baseline audiogram and not enrolled in a monitoring program)
CL Item
Dyspepsia (Heartburn/dyspepsia)
C26756 (NCI Thesaurus) C0013395 (UMLS 2011AA)
CL Item
Hematoma (Hematoma)
C50579 (NCI Thesaurus) C0018944 (UMLS 2011AA)
CL Item
Haemoglobin Decreased (Hemoglobin)
C0162119 (NCI Metathesaurus)
CL Item
Haemoglobinuria Present (Hemoglobinuria)
CL Item
Hemolysis Nos (Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis))
C0019054 (NCI Metathesaurus)
CL Item
Haemorrhagic Stroke (Hemorrhage, CNS)
CL036983 (NCI Metathesaurus)
CL Item
Melaena (Hemorrhage, GI - Abdomen NOS)
C0025222 (NCI Metathesaurus)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Anus)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Biliary tree)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Cecum/appendix)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Colon)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Duodenum)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Esophagus)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Ileum)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Jejunum)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Liver)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Lower GI NOS)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Oral cavity)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Pancreas)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Peritoneal cavity)
CL Item
Rectal Bleeding (Hemorrhage, GI - Rectum)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Stoma)
CL Item
Haematemesis (Hemorrhage, GI - Stomach)
C0018926 (NCI Metathesaurus)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Upper GI NOS)
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Varices (esophageal))
CL Item
Hemorrhage, Gi (Hemorrhage, GI - Varices (rectal))
Post-operative Haemorrhage (Hemorrhage/bleeding associated with surgery, intra-operative or post-operative)
CL Item
Hemorrhage/bleeding Other (Hemorrhage/Bleeding-Other (Specify))
CL Item
Hemorrhoids (Hemorrhoids)
CL Item
Hepatobiliary/pancreas Other (Hepatobiliary/Pancreas-Other (Specify))
CL Item
Hiccups (Hiccoughs (hiccups, singultus))
C0019521 (NCI Metathesaurus)
CL Item
Menopausal Symptoms (Hot flashes/flushes)
CL Item
Hydrocephalus (Hydrocephalus)
C3111 (NCI Thesaurus) C0020255 (UMLS 2011AA)
CL Item
Skin Discolouration (Hyperpigmentation)
CL Item
Hypertension Nos (Hypertension)
CL Item
Hypopigmentation (Hypopigmentation)
CL Item
Hypotension Nos (Hypotension)
CL Item
Hypothermia (Hypothermia)
C0020672 (NCI Metathesaurus)
CL Item
Hypoxia (Hypoxia)
C3890 (NCI Thesaurus) C0242184 (UMLS 2011AA)
CL Item
Ileus (Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation))
C37979 (NCI Thesaurus) C1258215 (UMLS 2011AA)
CL Item
Incontinence, Anal (Incontinence, anal)
CL Item
Urinary Incontinence (Incontinence, urinary)
C3429 (NCI Thesaurus) C0021167 (UMLS 2011AA)
CL Item
Induration/fibrosis (skin And Subcutaneous Tissue) (Induration/fibrosis (skin and subcutaneous tissue))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Abdomen NOS)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Anal/perianal)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Appendix)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Artery)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Biliary tree)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Bladder (urinary))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Bone (osteomyelitis))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Brain (encephalitis, infectious))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Brain + Spinal cord (encephalomyelitis))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Bronchus)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Catheter-related)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Cecum)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Cervix)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Colon)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Conjunctiva)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Cornea)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Dental-tooth)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Duodenum)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Esophagus)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - External ear (otitis externa))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Eye NOS)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Fallopian tube)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Foreign body (e.g., graft, implant, prosthesis, stent))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Gallbladder (cholecystitis))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Heart (endocarditis))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Ileum)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Jejunum)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Joint)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Kidney)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Larynx)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lens)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lip/perioral)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Liver)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumonia))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lymphatic)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Mediastinum NOS)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Meninges (meningitis))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Middle ear (otitis media))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Mucosa)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Muscle (infection myositis))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Neck NOS)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Nerve-cranial)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Nerve-peripheral)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Nose)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Oral cavity-gums (gingivitis))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Pancreas)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Paranasal)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Pelvis NOS)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Penis)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Peristomal)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Peritoneal cavity)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Pharynx)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Pleura (empyema))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Prostate)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Rectum)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Salivary gland)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Scrotum)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Sinus)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Skin (cellulitis))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Small bowel NOS)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Soft tissue NOS)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Spinal cord (myelitis))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Spleen)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Stomach)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Trachea)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Ungual (nails))
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Upper aerodigestive NOS)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Upper airway NOS)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Ureter)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Urethra)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Urinary tract NOS)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Uterus)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Vagina)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Vein)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Vulva)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Wound)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Abdomen NOS)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Anal/perianal)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Appendix)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Artery)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Biliary tree)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Blood)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Bone (osteomyelitis))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Brain (encephalitis, infectious))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Brain + Spinal cord (encephalomyelitis))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Bronchus)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Cecum)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Cervix)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Colon)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Conjunctiva)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Cornea)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Dental-tooth)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Duodenum)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Esophagus)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - External ear (otitis externa))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Eye NOS)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Fallopian tube)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Foreign body (e.g., graft, implant, prosthesis, stent))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Gallbladder (cholecystitis))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Heart (endocarditis))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Ileum)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Jejunum)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Joint)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Larynx)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Lens)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Lip/perioral)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Liver)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Lymphatic)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Mediastinum NOS)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Meninges (meningitis))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Middle ear (otitis media))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Mucosa)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Muscle (infection myositis))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Neck NOS)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Nerve-cranial)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Nerve-peripheral)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Nose)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Oral cavity-gums (gingivitis))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Pancreas)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Paranasal)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Pelvis NOS)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Penis)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Peristomal)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Peritoneal cavity)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Pharynx)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Pleura (empyema))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Prostate)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Rectum)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Salivary gland)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Scrotum)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Small bowel NOS)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Soft tissue NOS)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Spinal cord (myelitis))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Spleen)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Stomach)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Trachea)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Ungual (nails))
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Upper aerodigestive NOS)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Ureter)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Urethra)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Uterus)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Vagina)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Vein)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Vulva)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils - Wound)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Abdomen NOS)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Anal/perianal)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Appendix)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Artery)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Biliary tree)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Bladder (urinary))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Blood)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Bone (osteomyelitis))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Brain (encephalitis, infectious))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Brain + Spinal cord (encephalomyelitis))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Bronchus)
CL Item
Implant Infection (Infection with unknown ANC - Catheter-related)
CL039939 (NCI Metathesaurus)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Cecum)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Cervix)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Colon)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Conjunctiva)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Cornea)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Dental-tooth)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Duodenum)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Esophagus)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - External ear (otitis externa))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Eye NOS)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Fallopian tube)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Foreign body (e.g., graft, implant, prosthesis, stent))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Gallbladder (cholecystitis))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Heart (endocarditis))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Ileum)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Jejunum)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Joint)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Kidney)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Larynx)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Lens)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Lip/perioral)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Liver)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Lung (pneumonia))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Lymphatic)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Mediastinum NOS)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Meninges (meningitis))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Middle ear (otitis media))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Mucosa)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Muscle (infection myositis))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Neck NOS)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Nerve-cranial)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Nerve-peripheral)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Nose)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Oral cavity-gums (gingivitis))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Pancreas)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Paranasal)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Pelvis NOS)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Penis)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Peristomal)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Peritoneal cavity)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Pharynx)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Pleura (empyema))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Prostate)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Rectum)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Salivary gland)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Scrotum)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Sinus)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Skin (cellulitis))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Small bowel NOS)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Soft tissue NOS)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Spinal cord (myelitis))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Spleen)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Stomach)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Trachea)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Ungual (nails))
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Upper aerodigestive NOS)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Upper airway NOS)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Ureter)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Urethra)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Urinary tract NOS)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Uterus)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Vagina)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Vein)
CL Item
Infection With Unknown Anc (Infection with unknown ANC - Vulva)
CL Item
Culture Wound Positive (Infection with unknown ANC - Wound)
C0476436 (NCI Metathesaurus)
CL Item
Infection Nos (Infection-Other (Specify))
CL Item
Infertility/sterility (Infertility/sterility)
CL Item
Injection Site Reaction Nos (Injection site reaction/extravasation changes)
CL Item
Prothrombin Time Prolonged (INR (International Normalized Ratio of prothrombin time))
Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular)
CL Item
Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower)
CL Item
Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-upper)
CL Item
Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Facial)
CL Item
Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sided)
CL Item
Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Ocular)
CL Item
Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Pelvic)
CL Item
Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Right-sided)
CL Item
Muscle Weakness, Generalized Or Specific Area (not Due To Neuropathy) (Muscle weakness, generalized or specific area (not due to neuropathy) - Trunk)
CL Item
Muscle Weakness Nos (Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized)
General Disorders And Administration Site Conditions Class (General disorders and administration site conditions)
C49401 (NCI Thesaurus) C0851362 (UMLS 2011AA)
CL Item
Liver And Biliary Tract Disorder (Hepatobiliary disorders)
C3959 (NCI Thesaurus) C0267792 (UMLS 2011AA)
CL Item
Immune System Disorder (Immune system disorders)
C3507 (NCI Thesaurus) C0021053 (UMLS 2011AA)
CL Item
Infection And Infestation (Infections and infestations)
C26726 (NCI Thesaurus) C0009450 (UMLS 2011AA)
CL Item
Injury, Poisoning And Procedural Complication Class (Injury, poisoning and procedural complications)
C49402 (NCI Thesaurus) C0947733 (UMLS 2011AA)
CL Item
Investigation (Investigations)
C41198 (NCI Thesaurus) C1261322 (UMLS 2011AA)
CL Item
Metabolism And Nutrition Disorder Class (Metabolism and nutrition disorders)
C49403 (NCI Thesaurus) C0851358 (UMLS 2011AA)
CL Item
Connective And Soft Tissue Disorder (Musculoskeletal and connective tissue disorders)
C27574 (NCI Thesaurus) C1333150 (UMLS 2011AA)
CL Item
Neoplasm (Neoplasms benign, malignant and unspecified (incl cysts and polyps))
C3262 (NCI Thesaurus) C0027651 (UMLS 2011AA)
CL Item
Nervous System Disorder (Nervous system disorders)
C26835 (NCI Thesaurus) C0027765 (UMLS 2011AA)
CL Item
Pregnancy, Puerperium And Perinatal Condition Class (Pregnancy, puerperium and perinatal conditions)
C49404 (NCI Thesaurus) C0851363 (UMLS 2011AA)
CL Item
Psychiatric Disorder (Psychiatric disorders)
C2893 (NCI Thesaurus) C0004936 (UMLS 2011AA)
CL Item
Urinary Tract Disorder (Renal and urinary disorders)
C3430 (NCI Thesaurus) C0042075 (UMLS 2011AA)
CL Item
Reproductive System And Breast Disorder Class (Reproductive system and breast disorders)
C49405 (NCI Thesaurus) C0851366 (UMLS 2011AA)
CL Item
Respiratory And Thoracic Disorder (Respiratory, thoracic and mediastinal disorders)
C27669 (NCI Thesaurus) C0851355 (UMLS 2011AA)
CL Item
Skin Disorder (Skin and subcutaneous tissue disorders)
C3371 (NCI Thesaurus) C0037274 (UMLS 2011AA)
CL Item
Social Circumstances (Social circumstances)
C20188 (NCI Thesaurus) C0851364 (UMLS 2011AA)
CL Item
Intervention Or Procedure (Surgical and medical procedures)
C25218 (NCI Thesaurus) C1948041 (UMLS 2011AA)
CL Item
Vascular Disorder (Vascular disorders)
C35117 (NCI Thesaurus) C0042373 (UMLS 2011AA)
MedDRAAdverseEventCode
Item
MedDRA AE Code (CTCAE v3.0) (Code used to identify the adverse event using a standard mechanism that facilitates analysis. CTEP¿s code list and associated Category/Term is currently a standard.)
Were adverse events assessed during most recent period (Indicator to clarify whether any AEs were identified during the - reporting period. This is confirmation that the remainder of the form was intentionally left blank.)
Were adverse events assessed during most recent period (Indicator to clarify whether any AEs were identified during the - reporting period. This is confirmation that the remainder of the form was intentionally left blank.)
Course (May be used during protocol therapy period to automatically - set the evaluation start/end dates to the period of the course of treatment e.g. user supplies course# and evaluation period derived.)
Pre-existing AE? (Should be derivable if you capture AEs for specified periods; not needed if you track an AE until it resolves including worseningrather than for a defined assessment period.)
Pre-existing AE? (Should be derivable if you capture AEs for specified periods; not needed if you track an AE until it resolves including worseningrather than for a defined assessment period.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus) C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus) C1298908 (UMLS 2011AA)
AdverseEventResolutionTime
Item
AE Resolved Time (Enter the time of day when AE was resolved.)
Requires Inpatient Hospitalization Or Prolongation Of Existing Hospitalization (3)
CL Item
Results In Persistent Or Significant Disability/incapacity (4)
CL Item
Is A Congenital Anomaly/birth Defect (5)
CL Item
In The Medical Judgment Of The Treating Physician And/or Investigator, It May Jeopardize The Participant Or Require Intervention To Prevent One Of These Outcomes (6)
CL Item
Other, Specify (7)
CL Item
Meets Criteria Per Protocol But Does Not Meet Other Criterion (above) (8)