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  1. 1. Klinische Studie
  2. 2. Routinedokumentation
  3. 3. Register-/Kohortenstudien
  4. 4. Qualitätssicherung
  5. 5. Datenstandard
  6. 6. Patientenfragebogen
  7. 7. Medizinische Fachrichtung
    1. 7.1. Anästhesie
    1. 7.2. Dermatologie
    1. 7.3. HNO
    1. 7.4. Geriatrie
    1. 7.5. Gynäkologie/Geburtshilfe
    1. 7.6. Innere Medizin
      1. Hämatologie
      1. Infektiologie
      1. Kardiologie/Angiologie
      1. Pneumologie
      1. Gastroenterologie
      1. Nephrologie
      1. Endokrinologie/Stoffwechsel
      1. Rheumatologie
    1. 7.7. Neurologie
    1. 7.8. Augenheilkunde
    1. 7.9. Palliativmedizin
    1. 7.10. Pathologie/Rechtsmedizin
    1. 7.11. Kinderheilkunde
    1. 7.12. Psychiatrie/Psychosomatik
    1. 7.13. Radiologie
    1. 7.14. Chirurgie
      1. Allgemein-/Viszeralchirurgie
      1. Neurochirurgie
      1. Plastische Chirurgie
      1. Herz-/Thoraxchirurgie
      1. Unfallchirurgie/Orthopädie
      1. Gefäßchirurgie
    1. 7.15. Urologie
    1. 7.16. Zahnmedizin/MKG
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NINDS CDE Pregnancy Outcome Headache - Pregnancy Outcome

- 15.06.16 - 1 Formular, 3 Itemgruppen, 40 Datenelemente, 1 Sprache
Itemgruppen: Demographics, Pregnancy History, Details of Most Recent Live Birth
NINDS Common Data Elements (Pregnancy Outcome; Headache) Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

the Effect of Food on the Pharmacokinetics of a Tablet Formulation - 103268 - Pregnancy Report

- 13.03.19 - 1 Formular, 4 Itemgruppen, 48 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Pregnancy Notification Form, Drug Exposures, information investigator
Study ID: 103268 Clinical Study ID: 103268 Study Title: An Open Label, Randomised, Single Dose, Three-way Crossover Study to Investigate the Relative Bioavailability of Two Different Formulations of GSK163090 and the Effect of Food on the Pharmacokinetics of a Tablet Formulation in Healthy Male and Female Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00536679 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK163090 capsule, fasted/fed Trade Name: N/A Study Indication: Depression; Depressive Disorder and Anxiety Disorders

ICHOM Pregnancy and Childbirth - Postnatal checkup - Administrative Data

- 30.04.20 - 1 Formular, 7 Itemgruppen, 21 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Demographic, Obstetric and medical history, Treatment variables, Survival, Severe maternal morbidity, Neonatal morbidity
ICHOM Pregnancy and Childbirth data collection Version 1.0.3 Published: 10th April 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. The Pregnancy and Childbirth Standard Set of ICHOM includes outcomes to evaluate maternity care for all women during pregnancy, labor and delivery, and up to six month postpartum. ICHOMs Standard Set also includes a list of case-mix factors to allow for comparisons of outcomes across this broad patient population. Conditions: All women during: Pregnancy | Labor and delivery | Up to six months postpartum This document contains the Postnatal checkup - Administrative Data Form. It is the 1st postnatal checkup and has to be filled in between 2 and 8 weeks postpartum. Collecting Patient-Reported Outcome Measure: PROMIS-10. As there is an official distribution site for this questionnaire, only the total score will be included in this version of the standard set. For more information see: http://www.nihpromis.org/measures/translations International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF). As permission is needed for use of this questionnaire, only the total score will be included in this version of the standard set. For more information see: http:// www.iciq.net/userpolicy.html, https://iciq.net/user-agreement Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF). Free for use in clinical practice, routine outcomes measurement, and clinical research but requires permission from the developer. Please see Dennis, C-L. (2003) The Breastfeeding Self-Efficacy Scale: Psychometric assessment of the short form. Journal of Obstetric, Gynecologic, and Neonatal Nursing, 32, 734-744. For more information see: http://www.cindyleedennis.ca/research/#1-breastfeeding Wexner Scale (Cleveland Clinic Florida Fecal Incontinence Score). Free for use. No license is required. For more information see: Table 2 of Vaizey et al. (1999) Prospective comparison of faecal incontinence grading systems. Gut 44:77-80. Original Publication: Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77–97. Mother-to-Infant Bonding Scale (MIBS). As license condition for use of this scale is insufficiently clarified, only the total score will be included in this version of the standard set. The complete scoring guide as well as information on clinical interpretation can be found at: http://www.ncbi.nlm.nih.gov/pubmed/15868385: Taylor, A., Atkins, R., Kumar, R. et al. Arch Womens Ment Health (2005) 8: 45. https://doi.org/10.1007/s00737-005-0074-z Patient Health Questionnaire-2 (PHQ-2). Free for use. No license is required. Scoring and clinical interpretation can be found at: http://www. cqaimh.org/pdf/tool_phq2.pdf For more information see: https://www.phqscreeners.com/ Edinburgh Postnatal Depression Scale (EPDS). Free for use. No license is required. Users may reproduce the scale without permissions provided they respect copyright by quoting the names of the authors, the title and the source of the paper in all reproduced copies. The scoring guide and clinical interpretation can be found in: Cox JL et al (1987) Detection of postnatal depression development of the 10-item Edinburgh Postnatal Depression Scale. Birth Satisfaction Scale - Revised (BSS-R). Free for use in clinical practice, routine outcomes measurement, and clinical research but requires permission from the developer. For more information see: Hollins Martin CJ et al (2014) Development and psychometric properties of the Birth Satisfaction Scale - Revised (BSS-R). Midwifery 30: 610-619 Reference: Nijagal MA, Wissig S, Stowell C, et al. Standardized outcome measures for pregnancy and childbirth, an ICHOM proposal. BMC Health Serv Res. 2018;18(1):953. Published 2018 Dec 11. doi:10.1186/s12913-018-3732-3 The Standard set of ICHOM was supported by the hoag, HCF Research Foundation, Karolinska University Hospital and the Government of South Australia. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Pregnancy and Childbirth - Postpartum checkup - Patient reported

- 30.04.20 - 1 Formular, 8 Itemgruppen, 55 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Patient-reported health status, Breastfeeding, Role transition, Mental Health, Satisfaction with Care, Healthcare Responsiveness, Birth Experience
ICHOM Pregnancy and Childbirth data collection Version 1.0.3 Published: 10th April 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. The Pregnancy and Childbirth Standard Set of ICHOM includes outcomes to evaluate maternity care for all women during pregnancy, labor and delivery, and up to six month postpartum. ICHOMs Standard Set also includes a list of case-mix factors to allow for comparisons of outcomes across this broad patient population. Conditions: All women during: Pregnancy | Labor and delivery | Up to six months postpartum This document contains the Postpartum checkup - Patient reported Form. It has to be filled between 2 and 8 weeks postpartum. Collecting Patient-Reported Outcome Measure: PROMIS-10. As there is an official distribution site for this questionnaire, only the total score will be included in this version of the standard set. For more information see: http://www.nihpromis.org/measures/translations International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF). As permission is needed for use of this questionnaire, only the total score will be included in this version of the standard set. For more information see: http:// www.iciq.net/userpolicy.html, https://iciq.net/user-agreement Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF). Free for use in clinical practice, routine outcomes measurement, and clinical research but requires permission from the developer. Please see Dennis, C-L. (2003) The Breastfeeding Self-Efficacy Scale: Psychometric assessment of the short form. Journal of Obstetric, Gynecologic, and Neonatal Nursing, 32, 734-744. For more information see: http://www.cindyleedennis.ca/research/#1-breastfeeding Wexner Scale (Cleveland Clinic Florida Fecal Incontinence Score). Free for use. No license is required. For more information see: Table 2 of Vaizey et al. (1999) Prospective comparison of faecal incontinence grading systems. Gut 44:77-80. Original Publication: Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77–97. Mother-to-Infant Bonding Scale (MIBS). As license condition for use of this scale is insufficiently clarified, only the total score will be included in this version of the standard set. The complete scoring guide as well as information on clinical interpretation can be found at: http://www.ncbi.nlm.nih.gov/pubmed/15868385: Taylor, A., Atkins, R., Kumar, R. et al. Arch Womens Ment Health (2005) 8: 45. https://doi.org/10.1007/s00737-005-0074-z Patient Health Questionnaire-2 (PHQ-2). Free for use. No license is required. Scoring and clinical interpretation can be found at: http://www. cqaimh.org/pdf/tool_phq2.pdf For more information see: https://www.phqscreeners.com/ Edinburgh Postnatal Depression Scale (EPDS). Free for use. No license is required. Users may reproduce the scale without permissions provided they respect copyright by quoting the names of the authors, the title and the source of the paper in all reproduced copies. The scoring guide and clinical interpretation can be found in: Cox JL et al (1987) Detection of postnatal depression development of the 10-item Edinburgh Postnatal Depression Scale. Birth Satisfaction Scale - Revised (BSS-R). Free for use in clinical practice, routine outcomes measurement, and clinical research but requires permission from the developer. For more information see: Hollins Martin CJ et al (2014) Development and psychometric properties of the Birth Satisfaction Scale - Revised (BSS-R). Midwifery 30: 610-619 Reference: Nijagal MA, Wissig S, Stowell C, et al. Standardized outcome measures for pregnancy and childbirth, an ICHOM proposal. BMC Health Serv Res. 2018;18(1):953. Published 2018 Dec 11. doi:10.1186/s12913-018-3732-3 The Standard set of ICHOM was supported by the hoag, HCF Research Foundation, Karolinska University Hospital and the Government of South Australia. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Pregnancy and Childbirth - 6 months postpartum - Patient reported

- 30.04.20 - 1 Formular, 7 Itemgruppen, 29 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Patient-reported health status, Breastfeeding, Role transition, Mental Health, Satisfaction with Care, Healthcare Responsiveness
ICHOM Pregnancy and Childbirth data collection Version 1.0.3 Published: 10th April 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. The Pregnancy and Childbirth Standard Set of ICHOM includes outcomes to evaluate maternity care for all women during pregnancy, labor and delivery, and up to six month postpartum. ICHOMs Standard Set also includes a list of case-mix factors to allow for comparisons of outcomes across this broad patient population. Conditions: All women during: Pregnancy | Labor and delivery | Up to six months postpartum This document contains the 6 months postpartum - Patient reported Form. It has to be filled in between 22 and 26 weeks postpartum. Collecting Patient-Reported Outcome Measure: PROMIS-10. As there is an official distribution site for this questionnaire, only the total score will be included in this version of the standard set. For more information see: http://www.nihpromis.org/measures/translations International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF). As permission is needed for use of this questionnaire, only the total score will be included in this version of the standard set. For more information see: http:// www.iciq.net/userpolicy.html, https://iciq.net/user-agreement Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF). Free for use in clinical practice, routine outcomes measurement, and clinical research but requires permission from the developer. Please see Dennis, C-L. (2003) The Breastfeeding Self-Efficacy Scale: Psychometric assessment of the short form. Journal of Obstetric, Gynecologic, and Neonatal Nursing, 32, 734-744. For more information see: http://www.cindyleedennis.ca/research/#1-breastfeeding Wexner Scale (Cleveland Clinic Florida Fecal Incontinence Score). Free for use. No license is required. For more information see: Table 2 of Vaizey et al. (1999) Prospective comparison of faecal incontinence grading systems. Gut 44:77-80. Original Publication: Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77–97. Mother-to-Infant Bonding Scale (MIBS). As license condition for use of this scale is insufficiently clarified, only the total score will be included in this version of the standard set. The complete scoring guide as well as information on clinical interpretation can be found at: http://www.ncbi.nlm.nih.gov/pubmed/15868385: Taylor, A., Atkins, R., Kumar, R. et al. Arch Womens Ment Health (2005) 8: 45. https://doi.org/10.1007/s00737-005-0074-z Patient Health Questionnaire-2 (PHQ-2). Free for use. No license is required. Scoring and clinical interpretation can be found at: http://www. cqaimh.org/pdf/tool_phq2.pdf For more information see: https://www.phqscreeners.com/ Edinburgh Postnatal Depression Scale (EPDS). Free for use. No license is required. Users may reproduce the scale without permissions provided they respect copyright by quoting the names of the authors, the title and the source of the paper in all reproduced copies. The scoring guide and clinical interpretation can be found in: Cox JL et al (1987) Detection of postnatal depression development of the 10-item Edinburgh Postnatal Depression Scale. Birth Satisfaction Scale - Revised (BSS-R). Free for use in clinical practice, routine outcomes measurement, and clinical research but requires permission from the developer. For more information see: Hollins Martin CJ et al (2014) Development and psychometric properties of the Birth Satisfaction Scale - Revised (BSS-R). Midwifery 30: 610-619 Reference: Nijagal MA, Wissig S, Stowell C, et al. Standardized outcome measures for pregnancy and childbirth, an ICHOM proposal. BMC Health Serv Res. 2018;18(1):953. Published 2018 Dec 11. doi:10.1186/s12913-018-3732-3 The Standard set of ICHOM was supported by the hoag, HCF Research Foundation, Karolinska University Hospital and the Government of South Australia. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Pregnancy and Childbirth - Birth - Patient reported

- 30.04.20 - 1 Formular, 4 Itemgruppen, 27 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Patient-reported health status, Breastfeeding, Role transition
ICHOM Pregnancy and Childbirth data collection Version 1.0.3 Published: 10th April 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. The Pregnancy and Childbirth Standard Set of ICHOM includes outcomes to evaluate maternity care for all women during pregnancy, labor and delivery, and up to six month postpartum. ICHOMs Standard Set also includes a list of case-mix factors to allow for comparisons of outcomes across this broad patient population. Conditions: All women during: Pregnancy | Labor and delivery | Up to six months postpartum This document contains the Birth - Patient reported Form. It has to be filled in prior to discharge from birth unit or within 3 days postpartum. Collecting Patient-Reported Outcome Measure: PROMIS-10. As there is an official distribution site for this questionnaire, only the total score will be included in this version of the standard set. For more information see: http://www.nihpromis.org/measures/translations International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF). As permission is needed for use of this questionnaire, only the total score will be included in this version of the standard set. For more information see: http:// www.iciq.net/userpolicy.html, https://iciq.net/user-agreement Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF). Free for use in clinical practice, routine outcomes measurement, and clinical research but requires permission from the developer. Please see Dennis, C-L. (2003) The Breastfeeding Self-Efficacy Scale: Psychometric assessment of the short form. Journal of Obstetric, Gynecologic, and Neonatal Nursing, 32, 734-744. For more information see: http://www.cindyleedennis.ca/research/#1-breastfeeding Wexner Scale (Cleveland Clinic Florida Fecal Incontinence Score). Free for use. No license is required. For more information see: Table 2 of Vaizey et al. (1999) Prospective comparison of faecal incontinence grading systems. Gut 44:77-80. Original Publication: Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77–97. Mother-to-Infant Bonding Scale (MIBS). As license condition for use of this scale is insufficiently clarified, only the total score will be included in this version of the standard set. The complete scoring guide as well as information on clinical interpretation can be found at: http://www.ncbi.nlm.nih.gov/pubmed/15868385: Taylor, A., Atkins, R., Kumar, R. et al. Arch Womens Ment Health (2005) 8: 45. https://doi.org/10.1007/s00737-005-0074-z Patient Health Questionnaire-2 (PHQ-2). Free for use. No license is required. Scoring and clinical interpretation can be found at: http://www. cqaimh.org/pdf/tool_phq2.pdf For more information see: https://www.phqscreeners.com/ Edinburgh Postnatal Depression Scale (EPDS). Free for use. No license is required. Users may reproduce the scale without permissions provided they respect copyright by quoting the names of the authors, the title and the source of the paper in all reproduced copies. The scoring guide and clinical interpretation can be found in: Cox JL et al (1987) Detection of postnatal depression development of the 10-item Edinburgh Postnatal Depression Scale. Birth Satisfaction Scale - Revised (BSS-R). Free for use in clinical practice, routine outcomes measurement, and clinical research but requires permission from the developer. For more information see: Hollins Martin CJ et al (2014) Development and psychometric properties of the Birth Satisfaction Scale - Revised (BSS-R). Midwifery 30: 610-619 Reference: Nijagal MA, Wissig S, Stowell C, et al. Standardized outcome measures for pregnancy and childbirth, an ICHOM proposal. BMC Health Serv Res. 2018;18(1):953. Published 2018 Dec 11. doi:10.1186/s12913-018-3732-3 The Standard set of ICHOM was supported by the hoag, HCF Research Foundation, Karolinska University Hospital and the Government of South Australia. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Pregnancy Notification Form

- 16.04.19 - 1 Formular, 8 Itemgruppen, 55 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Reporter Information, Mother's relevant medical/family history, Father's relevant medical/family history, GSK Drug/Vaccine Information and Concomitant Medications, Current pregnancy information/status, Infant information, Relevant Laboratory Test and Procedures
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Pregnancy Notification Form form. Complete as may sections ofthis form for each subject who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail of fax (fax preferred) within two weeks ofleaming ofthepregnancy.After delivery complete the remaining sections and fax the form to GSK. Original pages should remain with the subject's Case Report From.

Pregnancy Follow- Up Form- Current Pregnancy Information Week 36 Mepolizumab HES NCT00086658 - Pregnancy Follow- Up Form- Current Pregnancy Information Week 36

- 15.07.17 - 1 Formular, 5 Itemgruppen, 39 Datenelemente, 1 Sprache
Itemgruppen: FOLLOW-UP Pregnancy, INFANT INFORMATION, PREGNANCY INFORMATION, drug exposures pregnancy, information investigator
Study part: Pregnancy Follow- Up Form- Current Pregnancy Information Week 36/ Early Withdrawal Visit.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Pregnancy Follow-Up Form- Current Pregnancy Information Week 38 Mepolizumab HES NCT00086658 - Pregnancy Follow-Up Form- Current Pregnancy Information Week 38

- 06.06.17 - 1 Formular, 5 Itemgruppen, 39 Datenelemente, 1 Sprache
Itemgruppen: FOLLOW-UP Pregnancy, INFANT INFORMATION, PREGNANCY INFORMATION, drug exposures pregnancy, information investigator
Study part: Pregnancy Follow-Up Form- Current Pregnancy Information Week 38.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Pregnancy Data

- 03.01.19 - 1 Formular, 7 Itemgruppen, 58 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Demography, Medical History, Pregnancy Information, Pregnancy Outcome Information, Child Information, Pregnancy Outcome Details
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Pregnancy Outcome Form

- 21.11.18 - 1 Formular, 5 Itemgruppen, 35 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Demography, Child Information, Pregnancy Outcome Information, Important Note
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

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