0 Ratings

ID

4051

Description

Prospektive, randomisierte, multizentrische Therapieoptimierungsstudie - Studienprotokoll AML2003 http://www.clinicaltrials.gov/ct2/show/NCT00180102

Link

http://www.clinicaltrials.gov/ct2/show/NCT00180102

Keywords

AML

Clinical Trial

Treatment Form

7/30/13 7/30/13 - Martin Dugas
9/24/15 9/24/15 - Martin Dugas
9/20/21 9/20/21 -

Uploaded on

July 30, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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1. Induktionstherapie - Unerwuenschte Ereignisse CTC 3.0 CRF AML2003 AML

model
Details

1. Induktionstherapie - Unerwuenschte Ereignisse CTC 3.0

1 forms

StudyEvent: AML
1. 1. Induktionstherapie - Unerwuenschte Ereignisse CTC 3.0

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Allgemeine Angaben

Item Group

General information

C0332118 (UMLS CUI 2011AB)
106227002 (SNOMEDCT_2012_01_31)

Klinik-Nr.

Item

Clinic no.:

integer

C0442592 (UMLS CUI 2011AB)
257585005 (SNOMEDCT_2012_01_31)
C0237753 (UMLS CUI 2011AB)
410680006 (SNOMEDCT_2012_01_31)
MTHU024869 (LOINC Version 232)

Patient No.: 2-

Item

Patient No.: 2-

integer

C1830427 (UMLS CUI 2011AB)
MTHU021361 (LOINC Version 232)

Patienten-Initialen

Item

Patient initials: (Last name/Forename)

string

C0030705 (UMLS CUI 2011AB)
116154003 (SNOMEDCT_2012_01_31)
C1555582 (UMLS CUI 2011AB)
IN (HL7 V3 2006_05)
C1301584 (UMLS CUI 2011AB)
397678008 (SNOMEDCT_2012_01_31)
MTHU020554 (LOINC Version 232)
C1443235 (UMLS CUI 2011AB)
408677003 (SNOMEDCT_2012_01_31)
MTHU020551 (LOINC Version 232)

allergic reaction

Item Group

allergic reaction

C1527304 (UMLS CUI 2011AB)
421668005 (SNOMEDCT_2012_01_31)
10001718 (MedDRA 14.1)
T78.40 (ICD-10-CM Version 2010)

allergic reaction

Item

allergic reaction

boolean

C1527304 (UMLS CUI 2011AB)
421668005 (SNOMEDCT_2012_01_31)
10001718 (MedDRA 14.1)
T78.40 (ICD-10-CM Version 2010)

Beginn

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

Ende

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (2)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Hämoglobin

Item Group

Hemoglobin

C0019046 (UMLS CUI 2011AB)
38082009 (SNOMEDCT_2012_01_31)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)

Hämoglobin

Item

Hemoglobin

boolean

C0019046 (UMLS CUI 2011AB)
38082009 (SNOMEDCT_2012_01_31)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)

Beginn

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

Ende

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensität

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensität

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (2)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Leukocytes

Item Group

Leukocytes

C0023516 (UMLS CUI 2011AB)
52501007 (SNOMEDCT_2012_01_31)
10047955 (MedDRA 14.1)
MTHU001946 (LOINC Version 232)

Leukocytes

Item

Leukocytes

boolean

C0023516 (UMLS CUI 2011AB)
52501007 (SNOMEDCT_2012_01_31)
10047955 (MedDRA 14.1)
MTHU001946 (LOINC Version 232)

Beginn

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

Ende

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensität

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensität

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Neutrophils

Item Group

Neutrophils

C0027950 (UMLS CUI 2011AB)
116712007 (SNOMEDCT_2012_01_31)
10029380 (MedDRA 14.1)
MTHU006207 (LOINC Version 232)

Neutrophils

Item

Neutrophils

boolean

C0027950 (UMLS CUI 2011AB)
116712007 (SNOMEDCT_2012_01_31)
10029380 (MedDRA 14.1)
MTHU006207 (LOINC Version 232)

Beginn

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

Ende

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensität

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensität

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (2)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

Kausalität (mit Studienmedikation)

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

Kausalität (mit Studienmedikation)

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Platelets

Item Group

Platelets

C0005821 (UMLS CUI 2011AB)
16378004 (SNOMEDCT_2012_01_31)
MTHU002432 (LOINC Version 232)

Platelets

Item

Platelets

boolean

C0005821 (UMLS CUI 2011AB)
16378004 (SNOMEDCT_2012_01_31)
MTHU002432 (LOINC Version 232)

Beginn

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

Ende

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensität

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensität

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Arrhythmias

Item Group

Arrhythmias

C0003811 (UMLS CUI 2011AB)
44808001 (SNOMEDCT_2012_01_31)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)

Arrhythmias

Item

Arrhythmias

boolean

C0003811 (UMLS CUI 2011AB)
44808001 (SNOMEDCT_2012_01_31)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)

Beginn

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

Ende

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensität

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensität

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Cardiac ischemia/infarction

Item Group

Cardiac ischemia/infarction

C1556254 (UMLS CUI 2011AB)
MTHU116749 (CTCAE 1105E)

Cardiac ischemia/infarction

Item

Cardiac ischemia/infarction

boolean

C1556254 (UMLS CUI 2011AB)
MTHU116749 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Hypertension

Item Group

Hypertension

C0020538 (UMLS CUI 2011AB)
38341003 (SNOMEDCT_2012_01_31)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)

Hypertension

Item

Hypertension

boolean

C0020538 (UMLS CUI 2011AB)
38341003 (SNOMEDCT_2012_01_31)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Hypotension

Item Group

Hypotension

C0020649 (UMLS CUI 2011AB)
45007003 (SNOMEDCT_2012_01_31)
10003146 (MedDRA 14.1)
I95 (ICD-10-CM Version 2010)
458 (ICD-9-CM Version 2011)

Hypotension

Item

Hypotension

boolean

C0020649 (UMLS CUI 2011AB)
45007003 (SNOMEDCT_2012_01_31)
10003146 (MedDRA 14.1)
I95 (ICD-10-CM Version 2010)
458 (ICD-9-CM Version 2011)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Left ventricular systolic dysfunction

Item Group

Left ventricular systolic dysfunction

C1277187 (UMLS CUI 2011AB)
134401001 (SNOMEDCT_2012_01_31)
10069501 (MedDRA 14.1)
E10130 (CTCAE 1105E)

Left ventricular systolic dysfunction

Item

Left ventricular systolic dysfunction

boolean

C1277187 (UMLS CUI 2011AB)
134401001 (SNOMEDCT_2012_01_31)
10069501 (MedDRA 14.1)
E10130 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Pericarditis

Item Group

Pericarditis

C0031046 (UMLS CUI 2011AB)
3238004 (SNOMEDCT_2012_01_31)
10034484 (MedDRA 14.1)
E10180 (CTCAE 1105E)

Pericarditis

Item

Pericarditis

boolean

C0031046 (UMLS CUI 2011AB)
3238004 (SNOMEDCT_2012_01_31)
10034484 (MedDRA 14.1)
E10180 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Pulmonary Hypertension

Item Group

Pulmonary Hypertension

C0020542 (UMLS CUI 2011AB)
70995007 (SNOMEDCT_2012_01_31)
10037400 (MedDRA 14.1)
I27.2 (ICD-10-CM Version 2010)
E13539 (CTCAE 1105E)

Pulmonary Hypertension

Item

Pulmonary Hypertension

boolean

C0020542 (UMLS CUI 2011AB)
70995007 (SNOMEDCT_2012_01_31)
10037400 (MedDRA 14.1)
I27.2 (ICD-10-CM Version 2010)
E13539 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

DIC

Item Group

DIC

C0012739 (UMLS CUI 2011AB)
67406007 (SNOMEDCT_2012_01_31)
10013442 (MedDRA 14.1)
D65 (ICD-10-CM Version 2010)
286.6 (ICD-9-CM Version 2011)
E10028 (CTCAE 1105E)

DIC

Item

DIC

boolean

C0012739 (UMLS CUI 2011AB)
67406007 (SNOMEDCT_2012_01_31)
10013442 (MedDRA 14.1)
D65 (ICD-10-CM Version 2010)
286.6 (ICD-9-CM Version 2011)
E10028 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Fibrinogen

Item Group

Fibrinogen

C0016006 (UMLS CUI 2011AB)
23295004 (SNOMEDCT_2012_01_31)
MTHU007030 (LOINC Version 232)

Fibrinogen

Item

Fibrinogen

boolean

C0016006 (UMLS CUI 2011AB)
23295004 (SNOMEDCT_2012_01_31)
MTHU007030 (LOINC Version 232)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Fever (Neutrophils > 1,0 GPt/l)

Item Group

Fever (Neutrophils > 1,0 GPt/l)

Item

Fever (Neutrophils > 1,0 GPt/l)

boolean

C0015967 (UMLS CUI 2011AB)
386661006 (SNOMEDCT_2012_01_31)
10005911 (MedDRA 14.1)
MTHU013518 (LOINC Version 232)
R50.9 (ICD-10-CM Version 2010)
780.60 (ICD-9-CM Version 2011)
E11102 (CTCAE 1105E)
C0027950 (UMLS CUI 2011AB)
116712007 (SNOMEDCT_2012_01_31)
10029380 (MedDRA 14.1)
MTHU006207 (LOINC Version 232)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Neutropenic fever

Item Group

Neutropenic fever >= 38,5 C (Neutrophils <= 1,0 GPt/l)

Neutropenic fever

Item

Neutropenic fever >= 38,5 C (Neutrophils <= 1,0 GPt/l)

boolean

C0746883 (UMLS CUI 2011AB)
409089005 (SNOMEDCT_2012_01_31)
10016288 (MedDRA 14.1)
E10033 (CTCAE 1105E)
C0027950 (UMLS CUI 2011AB)
116712007 (SNOMEDCT_2012_01_31)
10029380 (MedDRA 14.1)
MTHU006207 (LOINC Version 232)
C0001899 (UMLS CUI 2011AB)
56935002 (SNOMEDCT_2012_01_31)
MTHU006766 (LOINC Version 232)
C0475211 (UMLS CUI 2011AB)
258770004 (SNOMEDCT_2012_01_31)
l (HL7 V3 2006_05)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Rash/desquamation

Item Group

Rash/desquamation

C1559142 (UMLS CUI 2011AB)
MTHU117394 (CTCAE 1105E)

Rash/desquamation

Item

Rash/desquamation

boolean

C1559142 (UMLS CUI 2011AB)
MTHU117394 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Pancreas endocrine

Item Group

Pancreas endocrine (Glukoseintoleranz)

Pancreas endocrine

Item

Pancreas endocrine (Glukoseintoleranz)

boolean

C0030274 (UMLS CUI 2011AB)
15776009 (SNOMEDCT_2012_01_31)
MTHU012054 (LOINC Version 232)
C0521425 (UMLS CUI 2011AB)
C0271650 (UMLS CUI 2011AB)
267426009 (SNOMEDCT_2012_01_31)
10052426 (MedDRA 14.1)
R73.09 (ICD-10-CM Version 2010)
E12264 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Diarrhea

Item Group

Diarrhea

C0011991 (UMLS CUI 2011AB)
62315008 (SNOMEDCT_2012_01_31)
10012735 (MedDRA 14.1)
MTHU013347 (LOINC Version 232)
R19.7 (ICD-10-CM Version 2010)
787.91 (ICD-9-CM Version 2011)
E10572 (CTCAE 1105E)

Diarrhea

Item

Diarrhea

boolean

C0011991 (UMLS CUI 2011AB)
62315008 (SNOMEDCT_2012_01_31)
10012735 (MedDRA 14.1)
MTHU013347 (LOINC Version 232)
R19.7 (ICD-10-CM Version 2010)
787.91 (ICD-9-CM Version 2011)
E10572 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Dysphagia/Esophagitis/Gastritis/Ileus

Item Group

Dysphagia/Esophagitis/Gastritis/Ileus

Item

Dysphagia/Esophagitis/Gastritis/Ileus

boolean

C0011168 (UMLS CUI 2011AB)
40739000 (SNOMEDCT_2012_01_31)
10013950 (MedDRA 14.1)
MTHU029874 (LOINC Version 232)
R13 (ICD-10-CM Version 2010)
787.2 (ICD-9-CM Version 2011)
E10621 (CTCAE 1105E)
C0014868 (UMLS CUI 2011AB)
16761005 (SNOMEDCT_2012_01_31)
10030216 (MedDRA 14.1)
K20.9 (ICD-10-CM Version 2010)
530.10 (ICD-9-CM Version 2011)
E10687 (CTCAE 1105E)
C0017152 (UMLS CUI 2011AB)
4556007 (SNOMEDCT_2012_01_31)
10017853 (MedDRA 14.1)
K29.7 (ICD-10-CM Version 2010)
E10733 (CTCAE 1105E)
C1258215 (UMLS CUI 2011AB)
81060008 (SNOMEDCT_2012_01_31)
10021328 (MedDRA 14.1)
E10812 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Enteritis

Item Group

Enteritis

C0014335 (UMLS CUI 2011AB)
64613007 (SNOMEDCT_2012_01_31)
10014866 (MedDRA 14.1)
K52.9 (ICD-10-CM Version 2010)

Enteritis

Item

Enteritis

boolean

C0014335 (UMLS CUI 2011AB)
64613007 (SNOMEDCT_2012_01_31)
10014866 (MedDRA 14.1)
K52.9 (ICD-10-CM Version 2010)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Mukositis/Stomatitis

Item Group

Stomatitis and mucositis, unspecified

C1719714 (UMLS CUI 2011AB)
528.00 (ICD-9-CM Version 2011)

Mukositis/Stomatitis

Item

Stomatitis and mucositis, unspecified

boolean

C1719714 (UMLS CUI 2011AB)
528.00 (ICD-9-CM Version 2011)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Nausea and vomiting

Item Group

Nausea and vomiting

C0027498 (UMLS CUI 2011AB)
16932000 (SNOMEDCT_2012_01_31)
10028821 (MedDRA 14.1)
R11 (ICD-10-CM Version 2010)
787.01 (ICD-9-CM Version 2011)

Nausea and vomiting

Item

Nausea and vomiting

boolean

C0027498 (UMLS CUI 2011AB)
16932000 (SNOMEDCT_2012_01_31)
10028821 (MedDRA 14.1)
R11 (ICD-10-CM Version 2010)
787.01 (ICD-9-CM Version 2011)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Hemorrhage

Item Group

Hemorrhage

C0019080 (UMLS CUI 2011AB)
50960005 (SNOMEDCT_2012_01_31)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)

Hemorrhage

Item

Hemorrhage

boolean

C0019080 (UMLS CUI 2011AB)
50960005 (SNOMEDCT_2012_01_31)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Pankreatitis

Item Group

Pancreatitis

C0030305 (UMLS CUI 2011AB)
75694006 (SNOMEDCT_2012_01_31)
10033645 (MedDRA 14.1)
K85.9 (ICD-10-CM Version 2010)
577.0 (ICD-9-CM Version 2011)
E10930 (CTCAE 1105E)

Pankreatitis

Item

Pancreatitis

boolean

C0030305 (UMLS CUI 2011AB)
75694006 (SNOMEDCT_2012_01_31)
10033645 (MedDRA 14.1)
K85.9 (ICD-10-CM Version 2010)
577.0 (ICD-9-CM Version 2011)
E10930 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Infection

Item Group

Infection

C0021311 (UMLS CUI 2011AB)
257551009 (SNOMEDCT_2012_01_31)
10021789 (MedDRA 14.1)

Infection

Item

Infection

boolean

C0021311 (UMLS CUI 2011AB)
257551009 (SNOMEDCT_2012_01_31)
10021789 (MedDRA 14.1)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Alkaline Phosphatase

Item Group

Alkaline Phosphatase

C0002059 (UMLS CUI 2011AB)
57056007 (SNOMEDCT_2012_01_31)
MTHU005195 (LOINC Version 232)

Alkaline Phosphatase

Item

Alkaline Phosphatase

boolean

C0002059 (UMLS CUI 2011AB)
57056007 (SNOMEDCT_2012_01_31)
MTHU005195 (LOINC Version 232)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

ALAT, GPT

Item Group

ALAT, GPT

C0001899 (UMLS CUI 2011AB)
56935002 (SNOMEDCT_2012_01_31)
MTHU006766 (LOINC Version 232)

ALAT, GPT

Item

ALAT, GPT

boolean

C0001899 (UMLS CUI 2011AB)
56935002 (SNOMEDCT_2012_01_31)
MTHU006766 (LOINC Version 232)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

ASAT, GOT

Item Group

ASAT, GOT

C0004002 (UMLS CUI 2011AB)
26091008 (SNOMEDCT_2012_01_31)
MTHU004883 (LOINC Version 232)

ASAT, GOT

Item

ASAT, GOT

boolean

C0004002 (UMLS CUI 2011AB)
26091008 (SNOMEDCT_2012_01_31)
MTHU004883 (LOINC Version 232)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Bilirubin

Item Group

Bilirubin

C0011221 (UMLS CUI 2011AB)
79706000 (SNOMEDCT_2012_01_31)
1975-2 (LOINC Version 232)

Bilirubin

Item Group

Bilirubin

C0011221 (UMLS CUI 2011AB)
79706000 (SNOMEDCT_2012_01_31)
1975-2 (LOINC Version 232)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Creatinine

Item Group

Creatinine

C0010294 (UMLS CUI 2011AB)
15373003 (SNOMEDCT_2012_01_31)
10011358 (MedDRA 14.1)
38483-4 (LOINC Version 232)

Creatinine

Item

Creatinine

boolean

C0010294 (UMLS CUI 2011AB)
15373003 (SNOMEDCT_2012_01_31)
10011358 (MedDRA 14.1)
38483-4 (LOINC Version 232)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

GGT

Item Group

GGT

C0017040 (UMLS CUI 2011AB)
60153001 (SNOMEDCT_2012_01_31)
MTHU001941 (LOINC Version 232)

GGT

Item

GGT

boolean

C0017040 (UMLS CUI 2011AB)
60153001 (SNOMEDCT_2012_01_31)
MTHU001941 (LOINC Version 232)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Ataxia

Item Group

Ataxia

C0004134 (UMLS CUI 2011AB)
20262006 (SNOMEDCT_2012_01_31)
10003591 (MedDRA 14.1)
R27.0 (ICD-10-CM Version 2010)
E12597 (CTCAE 1105E)

Ataxia

Item

Ataxia

boolean

C0004134 (UMLS CUI 2011AB)
20262006 (SNOMEDCT_2012_01_31)
10003591 (MedDRA 14.1)
R27.0 (ICD-10-CM Version 2010)
E12597 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Motor neuropathy

Item Group

Motor neuropathy

C0235025 (UMLS CUI 2011AB)
95663000 (SNOMEDCT_2012_01_31)
10034580 (MedDRA 14.1)
E12762 (CTCAE 1105E)

Motor neuropathy

Item

Motor neuropathy

boolean

C0235025 (UMLS CUI 2011AB)
95663000 (SNOMEDCT_2012_01_31)
10034580 (MedDRA 14.1)
E12762 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Sensory neuropathy

Item Group

Sensory neuropathy

C0151313 (UMLS CUI 2011AB)
95662005 (SNOMEDCT_2012_01_31)
10034620 (MedDRA 14.1)
E12768 (CTCAE 1105E)

Sensory neuropathy

Item

Sensory neuropathy

boolean

C0151313 (UMLS CUI 2011AB)
95662005 (SNOMEDCT_2012_01_31)
10034620 (MedDRA 14.1)
E12768 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Seizures

Item Group

Seizures

C0036572 (UMLS CUI 2011AB)
91175000 (SNOMEDCT_2012_01_31)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)

Seizures

Item

Seizures

boolean

C0036572 (UMLS CUI 2011AB)
91175000 (SNOMEDCT_2012_01_31)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Nystagmus

Item Group

Nystagmus

C0028738 (UMLS CUI 2011AB)
563001 (SNOMEDCT_2012_01_31)
10029864 (MedDRA 14.1)
H55.0 (ICD-10-CM Version 2010)
379.50 (ICD-9-CM Version 2011)
E12748 (CTCAE 1105E)

Nystagmus

Item

Nystagmus

boolean

C0028738 (UMLS CUI 2011AB)
563001 (SNOMEDCT_2012_01_31)
10029864 (MedDRA 14.1)
H55.0 (ICD-10-CM Version 2010)
379.50 (ICD-9-CM Version 2011)
E12748 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Disorder of eye

Item Group

Disorder of eye

C0015397 (UMLS CUI 2011AB)
371405004 (SNOMEDCT_2012_01_31)
10015916 (MedDRA 14.1)
H44 (ICD-10-CM Version 2010)
379.90 (ICD-9-CM Version 2011)

Disorder of eye

Item

Disorder of eye

boolean

C0015397 (UMLS CUI 2011AB)
371405004 (SNOMEDCT_2012_01_31)
10015916 (MedDRA 14.1)
H44 (ICD-10-CM Version 2010)
379.90 (ICD-9-CM Version 2011)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Pain

Item Group

Pain

C0030193 (UMLS CUI 2011AB)
22253000 (SNOMEDCT_2012_01_31)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)

Pain

Item

Pain

boolean

C0030193 (UMLS CUI 2011AB)
22253000 (SNOMEDCT_2012_01_31)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Dyspnea

Item Group

Dyspnea

C0013404 (UMLS CUI 2011AB)
139201002 (SNOMEDCT_2012_01_31)
10013968 (MedDRA 14.1)
MTHU020850 (LOINC Version 232)
R06.0 (ICD-10-CM Version 2010)
786.05 (ICD-9-CM Version 2011)
E13368 (CTCAE 1105E)

Dyspnea

Item

Dyspnea

boolean

C0013404 (UMLS CUI 2011AB)
139201002 (SNOMEDCT_2012_01_31)
10013968 (MedDRA 14.1)
MTHU020850 (LOINC Version 232)
R06.0 (ICD-10-CM Version 2010)
786.05 (ICD-9-CM Version 2011)
E13368 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Hypoxia

Item Group

Hypoxia

C0242184 (UMLS CUI 2011AB)
389086002 (SNOMEDCT_2012_01_31)
10021143 (MedDRA 14.1)
E13388 (CTCAE 1105E)

Hypoxia

Item

Hypoxia

boolean

C0242184 (UMLS CUI 2011AB)
389086002 (SNOMEDCT_2012_01_31)
10021143 (MedDRA 14.1)
E13388 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Pleural effusion (non-malignant)

Item Group

Pleural effusion (non-malignant)

C1557756 (UMLS CUI 2011AB)
MTHU117209 (CTCAE 1105E)

Pleural effusion (non-malignant)

Item

Pleural effusion (non-malignant)

boolean

C1557756 (UMLS CUI 2011AB)
MTHU117209 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Pneumonitis/pulmonary infiltrates

Item Group

Pneumonitis/pulmonary infiltrates

C1557762 (UMLS CUI 2011AB)
MTHU117361 (CTCAE 1105E)

Pneumonitis/pulmonary infiltrates

Item

Pneumonitis/pulmonary infiltrates

boolean

C1557762 (UMLS CUI 2011AB)
MTHU117361 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Cystitis

Item Group

Cystitis

C0010692 (UMLS CUI 2011AB)
38822007 (SNOMEDCT_2012_01_31)
10011781 (MedDRA 14.1)
N30 (ICD-10-CM Version 2010)
595.9 (ICD-9-CM Version 2011)
E11309 (CTCAE 1105E)

Cystitis

Item

Cystitis

boolean

C0010692 (UMLS CUI 2011AB)
38822007 (SNOMEDCT_2012_01_31)
10011781 (MedDRA 14.1)
N30 (ICD-10-CM Version 2010)
595.9 (ICD-9-CM Version 2011)
E11309 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Tumor lysis syndrome

Item Group

Tumor lysis syndrome

C0041364 (UMLS CUI 2011AB)
277605001 (SNOMEDCT_2012_01_31)
10045170 (MedDRA 14.1)
E88.3 (ICD-10-CM Version 2010)
277.88 (ICD-9-CM Version 2011)
E12365 (CTCAE 1105E)

Tumor lysis syndrome

Item

Tumor lysis syndrome

boolean

C0041364 (UMLS CUI 2011AB)
277605001 (SNOMEDCT_2012_01_31)
10045170 (MedDRA 14.1)
E88.3 (ICD-10-CM Version 2010)
277.88 (ICD-9-CM Version 2011)
E12365 (CTCAE 1105E)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Thrombosis and Embolism

Item Group

Thrombosis and Embolism

C0085307 (UMLS CUI 2011AB)
10014523 (MedDRA 14.1)

Thrombosis and Embolism

Item

Thrombosis and Embolism

boolean

C0085307 (UMLS CUI 2011AB)
10014523 (MedDRA 14.1)

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

other

Item Group

Other

other

Item

Other:

string

begin

Item

Start date:

date

C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)

end

Item

End date:

date

C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)

Intensity

Item

Intensity

integer

C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)

Intensity

Code List

Intensity

CL Item

mild (1)

C2945599 (UMLS CUI 2011AB)
255604002 (SNOMEDCT_2012_01_31)

CL Item

Moderate (3)

C0205081 (UMLS CUI 2011AB)
6736007 (SNOMEDCT_2012_01_31)
M (HL7 V3 2006_05)

CL Item

Severe (3)

C0205082 (UMLS CUI 2011AB)
24484000 (SNOMEDCT_2012_01_31)

CL Item

Life Threatening (4)

C2826244 (UMLS CUI 2011AB)

causality

Item

Causality (with study medication)

integer

CL408815 (UMLS CUI 2011AB)
C0304229 (UMLS CUI 2011AB)
902003 (SNOMEDCT_2012_01_31)

causality

Code List

Causality (with study medication)

CL Item

no (1)

C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)

CL Item

possible (2)

C0332149 (UMLS CUI 2011AB)
371930009 (SNOMEDCT_2012_01_31)

CL Item

yes (sure) (3)

C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)

CL Item

unknown (0)

C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)

Unterschrift

Item Group

Signature

C1519316 (UMLS CUI 2011AB)

Datum

Item

Date

date

C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)

Name des Studienarztes/Unterschrift

Item

Name of study physician/Signature

string

C0027365 (UMLS CUI 2011AB)
MTHU008539 (LOINC Version 232)
C0008976 (UMLS CUI 2011AB)
110465008 (SNOMEDCT_2012_01_31)
C0031831 (UMLS CUI 2011AB)
309343006 (SNOMEDCT_2012_01_31)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
C1519316 (UMLS CUI 2011AB)

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1. Induktionstherapie - Unerwuenschte Ereignisse CTC 3.0 CRF AML2003 AML

1. Induktionstherapie - Unerwuenschte Ereignisse CTC 3.0

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