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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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Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Study Conclusion, Pregnancy Information and Investigator Comment Log

- 9/27/21 - 1 form, 5 itemgroups, 14 items, 1 language
Itemgroups: Administrative Data,Pregnancy Information,Study Conclusion,Investigator Comment Log,Investigator's Signature
This ODM file contains the form to document pregnancy information at the end of the study, the study conclusion and also includes an investigator's comment log. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Dose Level 1, Day1, Pre-dose - Prior Medication; Pregnancy Test; Alcohol Breath Test; Drug Screening (Urine); Vital Signs

- 9/20/21 - 1 form, 7 itemgroups, 31 items, 1 language
Itemgroups: Administrative,Prior Medication,Prior Medication ,Pregnancy Test,Alcohol Breath Test,Drug Screening (Urine) ,Vital Signs
Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812 - Pregnancy Notification Form (Subject's Partner)

- 5/18/21 - 1 form, 6 itemgroups, 45 items, 1 language
Itemgroups: Administrative,Pregnancy Notification Form (Subject's Partner) - Mother's Relevant Medical/Family History,Pregnancy Notification Form (Subject's Partner) - Father's Relevant Medical/Family History ,Pregnancy Notification Form (Subject's Partner) - Drug Exposures,Was the subject withdrawn from the study as a result of this pregnancy?,Pregnancy Notification Form (Subject's Partner) - Reporting Investigator Information
Study ID: 111406 Clinical Study ID: 111406 Study Title: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers using a Dose- Escalating, Randomized, Placebo-Controlled Study Design Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00721812 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Placebo, locally-acting anti-inflammatory compound GSK1399686 Study Indication: Inflammatory Bowel Diseases

Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533) - Follow-Up: Study Conclusion; Pregnancy Information

- 5/10/21 - 1 form, 4 itemgroups, 10 items, 1 language
Itemgroups: Administrative,Date of visit/assessment,Study Conclusion,Pregnancy Information
Study ID: 105533 Clinical Study ID: 105533 Study Title: A randomized, open-label, single-dose, four period cross-over study to evaluate the relative bioavailability of four formulations of GSK lisinopril compared to Zestril, and to compare over-incapsulated Zestril to Zestril Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Carvedilol Trade Name: Zestril Study Indication: Hypertension

Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532) - Baseline - PR/ Conmeds; Pregnancy; Sudden Onset of Sleep Questionnaire

- 3/15/21 - 1 form, 6 itemgroups, 39 items, 1 language
Itemgroups: Administrative,Prior/ Current Concomitant Medications,Prior/ current non-drug therapies,Non-drug therapies,Pregnancy,Sudden Onset of Sleep Questionnaire
Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Follow-Up - Pregnancy Information; Status of Treatment Blind, Study Conclusion

- 3/2/21 - 1 form, 3 itemgroups, 9 items, 1 language
Itemgroups: Pregnancy Information,Status of Treatment Blind,Study Conclusion
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

ISARIC/WHO Novel Coronavirus (nCoV) / COVID-19 Case Report Form - COVID-19 Case Report Form – Pregnancy Module

- 2/10/21 - 1 form, 6 itemgroups, 113 items, 1 language
Itemgroups: Participant Identification,Q1. Status on admission,Q2. Previous obstetric history,Q3. Delivery,Were any of the following samples tested?,Q4. Neonate Details (If multiple pregnancy complete Q4 for each baby)
This Case Report Form (CRF) is to be used together with the Core CRF or the RAPID CRF, to collect additional data to characterise COVID-19 infection in pregnancy. The form can be completed prospectively or retrospectively. The main or rapid COVID-19 CRF needs to be completed as well, using the same patient ID. Inclusion criteria: Pregnant woman with suspected or confirmed COVID-19. More information can be found at https://isaric.org/research/covid-19-clinical-research-resources/optional-crf-modules/

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

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