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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
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149 Search results.

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - End of Study - Pregnancy Information; Study Conclusion; Investigator Comment Log; Investigator's Signature

- 1/19/21 - 1 form, 5 itemgroups, 12 items, 1 language
Itemgroups: Administrative, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's Signature
Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096) - Screening - Demography; Child-bearing Potential; Pregnancy Test; Physical Examination; Vital Signs; Medical Conditions

- 1/6/21 - 1 form, 8 itemgroups, 25 items, 1 language
Itemgroups: Administrative, Demography, Child-Bearing Potential, Pregnancy Test, Physical Examination, Vital Signs, Vital Signs , Medical Conditions
Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Study Conclusion and Pregnancy Information

- 12/18/20 - 1 form, 3 itemgroups, 11 items, 1 language
Itemgroups: Administrative Data, Study Conclusion, Pregnancy information
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the Follow-Up Visit.

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Follow-Up - ECG; Vital Signs; Pulmonary Function Test; Pregnancy Information; Status of treatment blind; Study conclusion

- 12/5/20 - 1 form, 9 itemgroups, 36 items, 1 language
Itemgroups: Date of visit/assessment, ECG, Vital Signs - Follow-up 1, Vital Signs - Follow-up 2, Vital Signs - Follow-up 3, Pulmonary Function Tests, Pregnancy Information, Status of Treatment Blind, Study Conclusion
Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Pregnancy Information

- 11/29/20 - 1 form, 6 itemgroups, 63 items, 1 language
Itemgroups: Administrative , Demography and Medical History (Pregnancy Notification Form), Pregnancy Information (Pregnancy Notification Form) , Demography and Medical History (Pregnancy Outcome Form), Child Information (Pregnancy Outcome Form), Pregnancy Outcome Information (Pregnancy Outcome Form)
Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Conclusion

- 10/13/20 - 1 form, 4 itemgroups, 9 items, 1 language
Itemgroups: Date of visit, Assessment Date, Cessation of life, Pregnancy, Information, Conclusion, Clinical Research
Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Measurement Instrument Database for the Social Science (MIDSS) - The Pregnancy Related Beliefs Questionnaire (PRBQ)

- 9/30/20 - 1 form, 2 itemgroups, 54 items, 1 language
Itemgroups: Instructions, Belief
Moorhead, S. R. J., Owens, J., Scott, J. (2003). The Pregnancy Related Beliefs Questionnaire (PRBQ). Measurement Instrument Database for the Social Science. Retrieved 29.09.2020, from www.midss.ie Key references: Moorhead, S. R. J., Owens, J., and Scott, J. (2003). DEVELOPMENT AND PILOTING OF THE PREGNANCY RELATED BELIEFS QUESTIONNAIRE (PRBQ). Behavioural and Cognitive Psychotherapy, 31, 207-213. doi:10.1017/S1352465803002091 Primary use / Purpose: The Pregnancy Related Beliefs Questionnaire (PRBQ) is a 54-item inventory rated on 7 point Likert-type scale. Its purpose is to measure women’s' beliefs about pregnancy and make similar contributions as existing scales towards greater understanding and prediction of postnatal depression Background: Psychological measures have proven disappointing in the prediction of postnatal depression in women. To address this weakness, Moorhead, Owens, and Scott (2003) developed the Pregnancy Related Beliefs Questionnaire (PRBQ). The PRBQ was shown to correlate with several other constructs as measured by the Beck Depression Inventory (BDI), the Dysfunctional Attitude Scale, and the Cognitive Adaption to Stressful Events Questionnaire (CASE), as well as showing early potential in the prediction of postnatal depression. Psychometrics: The psychometric properties of the Pregnancy Related Beliefs Questionnaire (PRBQ) are discussed in Moorhead, Owens, and Scott (2003). Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.323

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Pregnancy Information; Study Conclusion; Investigator Comment Log; Investigator's Signature

- 8/3/20 - 1 form, 5 itemgroups, 12 items, 1 language
Itemgroups: Administrative, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's Signature
Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Follow-up

- 6/25/20 - 1 form, 10 itemgroups, 187 items, 1 language
Itemgroups: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Experimental drug, Continuation status, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Conclusion, Clinical Research, Cessation of life, Pregnancy, Information
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer 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: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Study Conclusion; Pregnancy Information; Investigator Comment Log, Investigator's Signature

- 6/23/20 - 1 form, 5 itemgroups, 13 items, 1 language
Itemgroups: Administrative, Study Conclusion, Pregnancy Information, Investigator Comment Log, Investigator's Signature
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Urine Pregnancy Test; Serology

- 6/15/20 - 1 form, 3 itemgroups, 7 items, 1 language
Itemgroups: Administrative, Urine Pregnancy Test (Complete for Female Subjects Only) (Screening, Day-1, Follow-up), Serology
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Pregnancy Notification Form (Subject's Partner)

- 6/9/20 - 1 form, 5 itemgroups, 44 items, 1 language
Itemgroups: Administrative, Pregnancy Notification Form - Mother's relevant medical/ family history, Pregnancy Notification Form - Father's relevant medical/ family history , Pregnancy Notification Form - Drug Exposures , Reporting Investigator Information
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced