HIS

1 forms
  1. StudyEvent: HIS
    1. HIS
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Positive for
Item
Positive for
string
Negative for
Item
Negative for
string
NARRATIVE
Item
NARRATIVE
string
C0277786 (UMLS CUI 2011AA)
33962009 (SNOMED CT 2011_0131)
MTHU001077 (LOINC Version 232)
Denies change in appetite or weight. Denies fever, chills, dizziness
Item
Denies change in appetite or weight. Denies fever, chills, dizziness
boolean
Appetite change
Item
Appetite change
boolean
C0232462 (UMLS CUI 2011AA)
64379006 (SNOMED CT 2011_0131)
10061428 (MedDRA 14.1)
C0232461 (UMLS CUI 2011AA-2)
72405004 (SNOMED CT 2011_0131-2)
10021654 (MedDRA 14.1-2)
Weight Gain
Item
Gewichtszunahme
boolean
C0043094 (UMLS CUI 2011AA)
262286000 (SNOMED CT 2011_0131)
10047899 (MedDRA 14.1)
MTHU020882 (LOINC Version 232)
E12224 (CTCAE 1105E)
Weight Loss
Item
Gewichtsabnahme
boolean
C0043096 (UMLS CUI 2011AA)
89362005 (SNOMED CT 2011_0131)
10047895 (MedDRA 14.1)
MTHU020881 (LOINC Version 232)
783.21 (ICD-9-CM Version 2011)
E12228 (CTCAE 1105E)
Fever
Item
Fieber
boolean
C0015967 (UMLS CUI 2011AA)
386661006 (SNOMED CT 2011_0131)
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)
Chills
Item
Schüttelfrost
boolean
C0085593 (UMLS CUI 2011AA)
43724002 (SNOMED CT 2011_0131)
10008531 (MedDRA 14.1)
MTHU013512 (LOINC Version 232)
R68.83 (ICD-10-CM Version 2010)
780.64 (ICD-9-CM Version 2011)
E11074 (CTCAE 1105E)
Dizziness
Item
Schwindel
boolean
C0012833 (UMLS CUI 2011AA)
404640003 (SNOMED CT 2011_0131)
10013573 (MedDRA 14.1)
E12631 (CTCAE 1105E)
Additional comments
Item
Additional comments
string
Item Group
EYE
Item
Auge
string
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Denies change in vision
Item
Denies change in vision
boolean
Denies diplopia, itchy/dry eyes, photophobia or eye pain
Item
Denies diplopia, itchy/dry eyes, photophobia or eye pain
boolean
Blurred vision
Item
unscharfes Sehen
boolean
C0344232 (UMLS CUI 2011AA)
111516008 (SNOMED CT 2011_0131)
10047513 (MedDRA 14.1)
368.8 (ICD-9-CM Version 2011)
E10346 (CTCAE 1105E)
Diplopia
Item
Doppeltsehen
string
C0012569 (UMLS CUI 2011AA)
24982008 (SNOMED CT 2011_0131)
10013036 (MedDRA 14.1)
H53.2 (ICD-10-CM Version 2010)
368.2 (ICD-9-CM Version 2011)
Itchy Eyes
Item
Jucken des Auges
string
C0022281 (UMLS CUI 2011AA)
74776002 (SNOMED CT 2011_0131)
10052140 (MedDRA 14.1)
Dry eyes
Item
Xerophthalmie
string
C0314719 (UMLS CUI 2011AA)
1249004 (SNOMED CT 2011_0131)
10013774 (MedDRA 14.1)
Change in Vision
Item
Sehstörung
string
C0547030 (UMLS CUI 2011AA)
63102001 (SNOMED CT 2011_0131)
10047543 (MedDRA 14.1)
MTHU013463 (LOINC Version 232)
H53 (ICD-10-CM Version 2010)
368 (ICD-9-CM Version 2011)
Loss of Vision
Item
Sehverlust
string
CL355222 (UMLS CUI 2011AA)
Glasses
Item
Brille
string
C0015421 (UMLS CUI 2011AA)
50121007 (SNOMED CT 2011_0131)
Color blindness
Item
Farbenblindheit
string
C0242225 (UMLS CUI 2011AA)
193683001 (SNOMED CT 2011_0131)
10010050 (MedDRA 14.1)
H53.5 (ICD-10-CM Version 2010)
368.5 (ICD-9-CM Version 2011)
Photophobia
Item
Lichtempfindlichkeit
string
C0085636 (UMLS CUI 2011AA)
409668002 (SNOMED CT 2011_0131)
10034960 (MedDRA 14.1)
H53.14 (ICD-10-CM Version 2010)
368.13 (ICD-9-CM Version 2011)
E10416 (CTCAE 1105E)
Pain
Item
Schmerz
string
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
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)
Item Group
EAR
Item
Ohr
string
C0013443 (UMLS CUI 2011AA)
117590005 (SNOMED CT 2011_0131)
MTHU001407 (LOINC Version 232)
Denies earache,deafness,tinnitus,vertigo,or discharge
Item
Denies earache,deafness,tinnitus,vertigo,or discharge
boolean
Earache
Item
Ohrenschmerzen
string
C0013456 (UMLS CUI 2011AA)
16001004 (SNOMED CT 2011_0131)
10014020 (MedDRA 14.1)
H92.0 (ICD-10-CM Version 2010)
388.7 (ICD-9-CM Version 2011)
E10262 (CTCAE 1105E)
Deafness
Item
Taubheit
string
C0011053 (UMLS CUI 2011AA)
10011878 (MedDRA 14.1)
H91.9 (ICD-10-CM Version 2010)
389.9 (ICD-9-CM Version 2011)
Tinnitus
Item
Tinnitus
string
C0040264 (UMLS CUI 2011AA)
60862001 (SNOMED CT 2011_0131)
10043882 (MedDRA 14.1)
H93.1 (ICD-10-CM Version 2010)
388.3 (ICD-9-CM Version 2011)
E10287 (CTCAE 1105E)
Vertigo
Item
Vertigo
string
C0042571 (UMLS CUI 2011AA)
399153001 (SNOMED CT 2011_0131)
10047340 (MedDRA 14.1)
R42 (ICD-10-CM Version 2010)
780.4 (ICD-9-CM Version 2011)
E10291 (CTCAE 1105E)
Discharge
Item
Ausfluss
string
C0012621 (UMLS CUI 2011AA)
75823008 (SNOMED CT 2011_0131)
Item Group
NOSE
Item
Nase
string
C0028429 (UMLS CUI 2011AA)
45206002 (SNOMED CT 2011_0131)
Denies rhinorrhea, epistaxis, sneezing, or sinus pain/tenderness
Item
Denies rhinorrhea, epistaxis, sneezing, or sinus pain/tenderness
boolean
Rhinorrhea
Item
Rhinorrhoe
string
C1260880 (UMLS CUI 2011AA)
64531003 (SNOMED CT 2011_0131)
10039101 (MedDRA 14.1)
Epistaxis
Item
Epistaxis
string
C0014591 (UMLS CUI 2011AA)
12441001 (SNOMED CT 2011_0131)
10015090 (MedDRA 14.1)
R04.0 (ICD-10-CM Version 2010)
784.7 (ICD-9-CM Version 2011)
E13374 (CTCAE 1105E)
Sneezing
Item
Niesen
string
C0037383 (UMLS CUI 2011AA)
76067001 (SNOMED CT 2011_0131)
10041232 (MedDRA 14.1)
R06.7 (ICD-10-CM Version 2010)
784.99 (ICD-9-CM Version 2011)
E13572 (CTCAE 1105E)
Sinus tenderness
Item
schmerzhafte Nasennebenhöhlen
string
C0240453 (UMLS CUI 2011AA)
Item Group
MOUTH
Item
Mund
string
C0230028 (UMLS CUI 2011AA)
123851003 (SNOMED CT 2011_0131)
Denies toothache, mouth sores, dysphagia, odynophagia
Item
Denies toothache, mouth sores, dysphagia, odynophagia
boolean
Toothache
Item
Zahnschmerzen
string
C0040460 (UMLS CUI 2011AA)
27355003 (SNOMED CT 2011_0131)
10044055 (MedDRA 14.1)
K08.8 (ICD-10-CM Version 2010)
E11054 (CTCAE 1105E)
Dysphagia
Item
Dysphagie
string
C0011168 (UMLS CUI 2011AA)
40739000 (SNOMED CT 2011_0131)
10013950 (MedDRA 14.1)
MTHU029874 (LOINC Version 232)
R13 (ICD-10-CM Version 2010)
787.2 (ICD-9-CM Version 2011)
E10621 (CTCAE 1105E)
Odynophagia
Item
Schluckschmerz
string
C0221150 (UMLS CUI 2011AA)
30233002 (SNOMED CT 2011_0131)
10030094 (MedDRA 14.1)
Mouth sores
Item
Aphthe
string
C0149745 (UMLS CUI 2011AA)
26284000 (SNOMED CT 2011_0131)
10028034 (MedDRA 14.1)
528.9 (ICD-9-CM Version 2011)
Item Group
Respiratory
Item
Pulmonal
string
C0035237 (UMLS CUI 2011AA)
20139000 (SNOMED CT 2011_0131)
MTHU001413 (LOINC Version 232)
Denies chest pain, shortness of breath, or cough
Item
Denies chest pain, shortness of breath, or cough
boolean
Shortness of breath
Item
Dyspnoe, Atemnot
string
C0013404 (UMLS CUI 2011AA)
139201002 (SNOMED CT 2011_0131)
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 on exertion
Item
Belastungsdyspnoe
string
C0231807 (UMLS CUI 2011AA)
60845006 (SNOMED CT 2011_0131)
10013971 (MedDRA 14.1)
Orthopnea
Item
Orthopnoe
string
C0085619 (UMLS CUI 2011AA)
62744007 (SNOMED CT 2011_0131)
10031123 (MedDRA 14.1)
R06.01 (ICD-10-CM Version 2010)
786.02 (ICD-9-CM Version 2011)
Cough
Item
Husten
string
C0010200 (UMLS CUI 2011AA)
49727002 (SNOMED CT 2011_0131)
10011224 (MedDRA 14.1)
R05 (ICD-10-CM Version 2010)
786.2 (ICD-9-CM Version 2011)
E13364 (CTCAE 1105E)
Sputum
Item
Sputum
string
C0038056 (UMLS CUI 2011AA)
45710003 (SNOMED CT 2011_0131)
10041802 (MedDRA 14.1)
MTHU001309 (LOINC Version 232)
Hemoptysis
Item
Hämoptyse
string
C0019079 (UMLS CUI 2011AA)
66857006 (SNOMED CT 2011_0131)
10018964 (MedDRA 14.1)
R04.2 (ICD-10-CM Version 2010)
786.3 (ICD-9-CM Version 2011)
Pain
Item
Schmerz
string
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
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)
Item Group
CARDIOVASCULAR
Item
Kardiovaskuläres System
string
C0007226 (UMLS CUI 2011AA)
113257007 (SNOMED CT 2011_0131)
MTHU001406 (LOINC Version 232)
Denies chest pain or palpitations
Item
Denies chest pain or palpitations
boolean
Chest pain
Item
Brustschmerzen
string
C0008031 (UMLS CUI 2011AA)
29857009 (SNOMED CT 2011_0131)
10008479 (MedDRA 14.1)
MTHU035552 (LOINC Version 232)
R07.9 (ICD-10-CM Version 2010)
786.5 (ICD-9-CM Version 2011)
LOCATION
Item
Ort
string
C0450429 (UMLS CUI 2011AA)
246267002 (SNOMED CT 2011_0131)
RADIATION
Item
Ausstrahlung
string
C0851346 (UMLS CUI 2011AA)
82107009 (SNOMED CT 2011_0131)
MTHU026213 (LOINC Version 232)
TYPE
Item
TYPE
string
SEVERITY
Item
Schweregrad der Erkrankung
string
CL425496 (UMLS CUI 2011AA)
EXACERBATING FACTORS
Item
Pain exacerbating factors
string
C1507007 (UMLS CUI 2011AA)
MTHU016555 (LOINC Version 232)
RELIEVING FACTORS
Item
Symptom relieving factors
string
C0436323 (UMLS CUI 2011AA)
162483007 (SNOMED CT 2011_0131)
TIMING
Item
Timing
string
C0449243 (UMLS CUI 2011AA)
MTHU008276 (LOINC Version 232)
Palpitations
Item
Palpitationen
string
C0030252 (UMLS CUI 2011AA)
80313002 (SNOMED CT 2011_0131)
10033557 (MedDRA 14.1)
R00.2 (ICD-10-CM Version 2010)
785.1 (ICD-9-CM Version 2011)
E10163 (CTCAE 1105E)
Orthopnea
Item
Orthopnoe
string
C0085619 (UMLS CUI 2011AA)
62744007 (SNOMED CT 2011_0131)
10031123 (MedDRA 14.1)
R06.01 (ICD-10-CM Version 2010)
786.02 (ICD-9-CM Version 2011)
PND
Item
Paroxysmale nächtliche Dyspnoe
string
C1956415 (UMLS CUI 2011AA)
55442000 (SNOMED CT 2011_0131)
10013974 (MedDRA 14.1)
Leg edema
Item
Beinödeme
string
C0235886 (UMLS CUI 2011AA)
102574007 (SNOMED CT 2011_0131)
10024127 (MedDRA 14.1)
GASTROINTESTINAL
Item
Gastrointestinales System
string
C0012240 (UMLS CUI 2011AA)
86762007 (SNOMED CT 2011_0131)
MTHU001048 (LOINC Version 232)
Denies heartburn, abdominal pain, nausea, vomiting, blood in stool,diarrhea, or constipation.
Item
Denies heartburn, abdominal pain, nausea, vomiting, blood in stool,diarrhea, or constipation.
boolean
heartburn
Item
Sodbrennen
string
C0018834 (UMLS CUI 2011AA)
16331000 (SNOMED CT 2011_0131)
10019326 (MedDRA 14.1)
R12 (ICD-10-CM Version 2010)
787.1 (ICD-9-CM Version 2011)
abdominal pain
Item
Bauchschmerzen
string
C0000737 (UMLS CUI 2011AA)
21522001 (SNOMED CT 2011_0131)
10000081 (MedDRA 14.1)
MTHU013636 (LOINC Version 232)
R10.9 (ICD-10-CM Version 2010)
789.0 (ICD-9-CM Version 2011)
E10460 (CTCAE 1105E)
nausea
Item
Übelkeit
string
C0027497 (UMLS CUI 2011AA)
422587007 (SNOMED CT 2011_0131)
10028813 (MedDRA 14.1)
MTHU013524 (LOINC Version 232)
R11.0 (ICD-10-CM Version 2010)
E10878 (CTCAE 1105E)
Vomiting
Item
Erbrechen
string
C0042963 (UMLS CUI 2011AA)
249497008 (SNOMED CT 2011_0131)
10047700 (MedDRA 14.1)
MTHU013530 (LOINC Version 232)
R11.1 (ICD-10-CM Version 2010)
E11068 (CTCAE 1105E)
Incontinence
Item
Inkontinenz
string
C0021167 (UMLS CUI 2011AA)
48340000 (SNOMED CT 2011_0131)
10021639 (MedDRA 14.1)
Hematemesis
Item
Hämatemesis
string
C0018926 (UMLS CUI 2011AA)
8765009 (SNOMED CT 2011_0131)
10018830 (MedDRA 14.1)
K92.0 (ICD-10-CM Version 2010)
578.0 (ICD-9-CM Version 2011)
Diarrhea
Item
Diarrhö
string
C0011991 (UMLS CUI 2011AA)
62315008 (SNOMED CT 2011_0131)
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)
Constipation
Item
Verstopfung
string
C0009806 (UMLS CUI 2011AA)
14760008 (SNOMED CT 2011_0131)
10010774 (MedDRA 14.1)
MTHU020768 (LOINC Version 232)
K59.0 (ICD-10-CM Version 2010)
564.0 (ICD-9-CM Version 2011)
E10562 (CTCAE 1105E)
bright red blood in stool
Item
bright red blood in stool
string
Hematochezia
Item
Blut im Stuhl
string
C0018932 (UMLS CUI 2011AA)
405729008 (SNOMED CT 2011_0131)
10018836 (MedDRA 14.1)
578.1 (ICD-9-CM Version 2011)
Melena
Item
Teerstuhl
string
C0025222 (UMLS CUI 2011AA)
2901004 (SNOMED CT 2011_0131)
10027141 (MedDRA 14.1)
K92.1 (ICD-10-CM Version 2010)
Item Group
GENITOURINARY
Item
Urogenitales System
string
C0042066 (UMLS CUI 2011AA)
21514008 (SNOMED CT 2011_0131)
MTHU013232 (LOINC Version 232)
Denies dysuria, hematuria
Item
Denies dysuria, hematuria
boolean
dysuria
Item
Dysurie
string
C0013428 (UMLS CUI 2011AA)
49650001 (SNOMED CT 2011_0131)
10013990 (MedDRA 14.1)
R30 (ICD-10-CM Version 2010)
788.1 (ICD-9-CM Version 2011)
hematuria
Item
Hämaturie
string
C0018965 (UMLS CUI 2011AA)
34436003 (SNOMED CT 2011_0131)
10018867 (MedDRA 14.1)
R31 (ICD-10-CM Version 2010)
599.7 (ICD-9-CM Version 2011)
E13000 (CTCAE 1105E)
impotence
Item
Impotenz
string
C0242350 (UMLS CUI 2011AA)
397803000 (SNOMED CT 2011_0131)
10061461 (MedDRA 14.1)
N52 (ICD-10-CM Version 2010)
302.72 (ICD-9-CM Version 2011)
E13088 (CTCAE 1105E)
vaginal bleeding
Item
vaginale Blutung
string
C0151706 (UMLS CUI 2011AA)
289530006 (SNOMED CT 2011_0131)
10046910 (MedDRA 14.1)
623.8 (ICD-9-CM Version 2011)
E13264 (CTCAE 1105E)
vaginal discharge
Item
Vaginaler Ausfluss
string
C0227791 (UMLS CUI 2011AA)
271939006 (SNOMED CT 2011_0131)
10046901 (MedDRA 14.1)
623.5 (ICD-9-CM Version 2011)
E13251 (CTCAE 1105E)
dyspareunia
Item
Dyspareunie
string
C1384606 (UMLS CUI 2011AA)
71315007 (SNOMED CT 2011_0131)
10013941 (MedDRA 14.1)
E13081 (CTCAE 1105E)
MUSCULOSKELETAL
Item
Muskuloskeletales System
string
C0026860 (UMLS CUI 2011AA)
26107004 (SNOMED CT 2011_0131)
MTHU001411 (LOINC Version 232)
Denies muscle or joint pain or swelling.
Item
Denies muscle or joint pain or swelling.
boolean
muscle pain
Item
Myalgie
string
C0231528 (UMLS CUI 2011AA)
68962001 (SNOMED CT 2011_0131)
10028323 (MedDRA 14.1)
MTHU013523 (LOINC Version 232)
M79.1 (ICD-10-CM Version 2010)
E12485 (CTCAE 1105E)
back pain
Item
Rückenschmerzen
string
C0004604 (UMLS CUI 2011AA)
161891005 (SNOMED CT 2011_0131)
10003988 (MedDRA 14.1)
MTHU020857 (LOINC Version 232)
M54 (ICD-10-CM Version 2010)
724.5 (ICD-9-CM Version 2011)
E12388 (CTCAE 1105E)
stiffness
Item
Steifheit
string
C0427008 (UMLS CUI 2011AA)
271587009 (SNOMED CT 2011_0131)
10042045 (MedDRA 14.1)
joint pain
Item
Arthralgie
string
C0003862 (UMLS CUI 2011AA)
57676002 (SNOMED CT 2011_0131)
10003239 (MedDRA 14.1)
MTHU020863 (LOINC Version 232)
M25.5 (ICD-10-CM Version 2010)
719.4 (ICD-9-CM Version 2011)
E12374 (CTCAE 1105E)
joint swelling
Item
Gelenksschwellung
string
C0152031 (UMLS CUI 2011AA)
271771009 (SNOMED CT 2011_0131)
10023232 (MedDRA 14.1)
719.0 (ICD-9-CM Version 2011)
Item Group
NEUROLOGIC
Item
Nervensystem
string
C0027763 (UMLS CUI 2011AA)
25087005 (SNOMED CT 2011_0131)
MTHU001437 (LOINC Version 232)
Denies headache, dizziness, weakness or paresthesias
Item
Denies headache, dizziness, weakness or paresthesias
boolean
Dizziness
Item
Schwindel
string
C0012833 (UMLS CUI 2011AA)
404640003 (SNOMED CT 2011_0131)
10013573 (MedDRA 14.1)
E12631 (CTCAE 1105E)
Headache
Item
Kopfschmerz
string
C0018681 (UMLS CUI 2011AA)
25064002 (SNOMED CT 2011_0131)
10019211 (MedDRA 14.1)
MTHU020860 (LOINC Version 232)
R51 (ICD-10-CM Version 2010)
784.0 (ICD-9-CM Version 2011)
E12678 (CTCAE 1105E)
weakness
Item
Schwäche
string
CL356155 (UMLS CUI 2011AA)
R53 (ICD-10-CM Version 2010)
paresthesia
Item
Parästhesie
string
C0030554 (UMLS CUI 2011AA)
91019004 (SNOMED CT 2011_0131)
10033775 (MedDRA 14.1)
782.0 (ICD-9-CM Version 2011)
E12758 (CTCAE 1105E)
Item Group
Pain
Item
Schmerz
string
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
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 severity
Item
Stärke des Schmerzes
integer
C1507013 (UMLS CUI 2011AA)
MTHU016554 (LOINC Version 232)
LOCATION
Item
Ort
string
C0450429 (UMLS CUI 2011AA)
246267002 (SNOMED CT 2011_0131)
Radiation
Item
Ausstrahlung
string
C0851346 (UMLS CUI 2011AA)
82107009 (SNOMED CT 2011_0131)
MTHU026213 (LOINC Version 232)
EXACERBATING FACTORS
Item
EXACERBATING FACTORS
string
RELIEVING FACTORS
Item
RELIEVING FACTORS
string
Item Group
GERIATRIC
Item
geriatrisch
string
C1704440 (UMLS CUI 2011AA)
Falls
Item
Stürze
boolean
C0085639 (UMLS CUI 2011AA)
161898004 (SNOMED CT 2011_0131)
10016173 (MedDRA 14.1)
W00-W19.9 (ICD-10-CM Version 2010)
E880-E888 (ICD-9-CM Version 2011)
E11687 (CTCAE 1105E)
Incontinence
Item
Inkontinenz
boolean
C0021167 (UMLS CUI 2011AA)
48340000 (SNOMED CT 2011_0131)
10021639 (MedDRA 14.1)
Memory loss
Item
Gedächtnisverlust
boolean
C0751295 (UMLS CUI 2011AA)
10027176 (MedDRA 14.1)
MTHU013522 (LOINC Version 232)
780.93 (ICD-9-CM Version 2011)
Wandering
Item
Wandering, Wandering around
boolean
C0233569 (UMLS CUI 2011AA)
50239007 (SNOMED CT 2011_0131)
10047815 (MedDRA 14.1)
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