ID
4342
Description
ODM derived from http://clinicaltrials.gov/show/NCT01021670
Link
http://clinicaltrials.gov/show/NCT01021670
Keywords
Versions (1)
- 12/7/13 12/7/13 - Martin Dugas
Uploaded on
December 7, 2013
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT01021670 Sexual Dysfunction, Physiological
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
In accordance with the contraindications, special warnings and precautions for use as stated in the Summary of Product Characteristics for dapoxetine hydrochloride, patients will be excluded from treatment if they have hypersensitivity to dapoxetine hydrochloride or to any of the excipients
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0332290
- SNOMED CT 2011_0131
- 385433004
- UMLS CUI 2011AA
- C1301624
- SNOMED CT 2011_0131
- 397745006
- UMLS CUI 2011AA
- C1709515
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0970823
- UMLS CUI 2011AA
- C0015237
- SNOMED CT 2011_0131
- 360215002
Description
Significant pathological cardiac conditions such as: heart failure (New York Heart Association [NYHA] class II-IV), conduction abnormalities (second or third degree atrioventicular (AV) block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease, or significant valvular disease
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1522601
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C0018801
- SNOMED CT 2011_0131
- 155374007
- MedDRA 14.1
- 10019279
- ICD-9-CM Version 2011
- 428
- CTCAE 1105E
- E10124
- UMLS CUI 2011AA
- C1319794
- SNOMED CT 2011_0131
- 421704003
- MedDRA 14.1
- 10064080
- UMLS CUI 2011AA
- C1319795
- SNOMED CT 2011_0131
- 420913000
- MedDRA 14.1
- 10064081
- UMLS CUI 2011AA
- C1319796
- SNOMED CT 2011_0131
- 422293003
- MedDRA 14.1
- 10064082
- UMLS CUI 2011AA
- C1842820
- UMLS CUI 2011AA
- C0264906
- SNOMED CT 2011_0131
- 195042002
- MedDRA 14.1
- 10003677
- ICD-10-CM Version 2010
- I44.1
- UMLS CUI 2011AA
- C0151517
- SNOMED CT 2011_0131
- 27885002
- MedDRA 14.1
- 10003673
- ICD-10-CM Version 2010
- I44.2
- ICD-9-CM Version 2011
- 426.0
- CTCAE 1105E
- E10093
- UMLS CUI 2011AA
- C0037052
- SNOMED CT 2011_0131
- 36083008
- MedDRA 14.1
- 10040639
- ICD-10-CM Version 2010
- I49.5
- CTCAE 1105E
- E10202
- UMLS CUI 2011AA
- C0151744
- SNOMED CT 2011_0131
- 414795007, 414545008
- MedDRA 14.1
- 10028600
- LOINC Version 232
- MTHU024507
- ICD-10-CM Version 2010
- I20-I25
- ICD-9-CM Version 2011
- 410-414.99
- UMLS CUI 2011AA
- C0026265
- SNOMED CT 2011_0131
- 11851006
- MedDRA 14.1
- 10061532
- ICD-9-CM Version 2011
- 424.0
- CTCAE 1105E
- E10134
Description
Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with an MAOI
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1707479
- UMLS CUI 2011AA
- C1444662
- SNOMED CT 2011_0131
- 410546004
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0026457
Description
Concomitant treatment with thioridazine, concomitant treatment with serotonin reuptake inhibitors (selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], tricyclic antidepressants [TCAs)] or other medicinal/herbal products with serotonergic effects (for example, L-tryptophan, triptans, tramadol, linezolid, lithium, St. John's Wort (Hypericum perforatum)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1707479
- UMLS CUI 2011AA
- C0039943
- SNOMED CT 2011_0131
- 33588000
- LOINC Version 232
- MTHU003228
- UMLS CUI 2011AA
- C2911696
- UMLS CUI 2011AA
- C0360105
- SNOMED CT 2011_0131
- 349854005
- UMLS CUI 2011AA
- C1579361
- UMLS CUI 2011AA
- C0003290
- SNOMED CT 2011_0131
- 373253007
- LOINC Version 232
- MTHU001920
- UMLS CUI 2011AA
- C0041249
- SNOMED CT 2011_0131
- 108952000
- LOINC Version 232
- MTHU004124
- UMLS CUI 2011AA
- C1567966
- UMLS CUI 2011AA
- C0040610
- SNOMED CT 2011_0131
- 108507005
- LOINC Version 232
- MTHU003394
- UMLS CUI 2011AA
- C0663241
- SNOMED CT 2011_0131
- 125695009
- LOINC Version 232
- MTHU013614
- UMLS CUI 2011AA
- C0023870
- SNOMED CT 2011_0131
- 85899009
- LOINC Version 232
- MTHU004197
- UMLS CUI 2011AA
- C0936242
- SNOMED CT 2011_0131
- 51621002
Description
Concomitant treatment of potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, etc.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1707479
- UMLS CUI 2011AA
- C1142644
- SNOMED CT 2011_0131
- 422741004
- UMLS CUI 2011AA
- C0243077
- UMLS CUI 2011AA
- C0022625
- SNOMED CT 2011_0131
- 387216007
- LOINC Version 232
- MTHU002299
- UMLS CUI 2011AA
- C0064113
- SNOMED CT 2011_0131
- 387532006
- LOINC Version 232
- MTHU002298
- UMLS CUI 2011AA
- C0292818
- SNOMED CT 2011_0131
- 386896009
- LOINC Version 232
- MTHU013855
- UMLS CUI 2011AA
- C0286738
- SNOMED CT 2011_0131
- 108700005
- LOINC Version 232
- MTHU008513
- UMLS CUI 2011AA
- C1452484
- SNOMED CT 2011_0131
- 395260006
- LOINC Version 232
- MTHU016681
- UMLS CUI 2011AA
- C0068485
- SNOMED CT 2011_0131
- 108435006
- LOINC Version 232
- MTHU003461
- UMLS CUI 2011AA
- C0525005
- SNOMED CT 2011_0131
- 108706004
- LOINC Version 232
- MTHU013848
- UMLS CUI 2011AA
- C1145759
- SNOMED CT 2011_0131
- 413591007
- LOINC Version 232
- MTHU018644
Description
Moderate and severe hepatic impairment
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1881878
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0948807
- MedDRA 14.1
- 10052254
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Eligibility
- StudyEvent: Eligibility
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T78.40 (ICD-10-CM Version 2010)
C0970823 (UMLS CUI 2011AA)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C1319794 (UMLS CUI 2011AA)
421704003 (SNOMED CT 2011_0131)
10064080 (MedDRA 14.1)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C1842820 (UMLS CUI 2011AA)
C0264906 (UMLS CUI 2011AA)
195042002 (SNOMED CT 2011_0131)
10003677 (MedDRA 14.1)
I44.1 (ICD-10-CM Version 2010)
C0151517 (UMLS CUI 2011AA)
27885002 (SNOMED CT 2011_0131)
10003673 (MedDRA 14.1)
I44.2 (ICD-10-CM Version 2010)
426.0 (ICD-9-CM Version 2011)
E10093 (CTCAE 1105E)
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10040639 (MedDRA 14.1)
I49.5 (ICD-10-CM Version 2010)
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10028600 (MedDRA 14.1)
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11851006 (SNOMED CT 2011_0131)
10061532 (MedDRA 14.1)
424.0 (ICD-9-CM Version 2011)
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C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0026457 (UMLS CUI 2011AA)
C0039943 (UMLS CUI 2011AA)
33588000 (SNOMED CT 2011_0131)
MTHU003228 (LOINC Version 232)
C2911696 (UMLS CUI 2011AA)
C0360105 (UMLS CUI 2011AA)
349854005 (SNOMED CT 2011_0131)
C1579361 (UMLS CUI 2011AA)
C0003290 (UMLS CUI 2011AA)
373253007 (SNOMED CT 2011_0131)
MTHU001920 (LOINC Version 232)
C0041249 (UMLS CUI 2011AA)
108952000 (SNOMED CT 2011_0131)
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395260006 (SNOMED CT 2011_0131)
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