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Vital Signs- Follow- Up Pazopanib Macular Degeneration MD1103367 - Vital Signs- Follow- Up

- 2021-09-20 - 1 Formulär, 1 Item-grupp, 7 Dataelement, 1 Språk

Item-grupp: Vital signs measurements

Study part: Vital Signs- Follow- Up. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

12 Lead ECG- Follow-up Pazopanib Macular Degeneration MD1103367 - 12 Lead ECG- Follow-up

- 2018-06-20 - 1 Formulär, 1 Item-grupp, 8 Dataelement, 1 Språk

Item-grupp: 12 Lead ECG; Follow- up

Study part: 12 Lead ECG- Follow-up. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 2017-10-10 - 1 Formulär, 18 Item-grupper, 72 Dataelement, 1 Språk

Item-grupper: Concomitant medication, Adverse event, Patient diary, 12-lead electrocardiogram report, orthostatic blood pressure / Pulse, Pregnancy test, Physical examination, Hematology Laboratory evaluation, Hematology Laboratory evaluation, Serum Laboratory evaluation, Serum laboratory evaluation, Urinalysis, Dip stick analysis, Microscopic analysis, Overall urinalysis assessment, Study Completion Part A, Study Completion Part B, Investigator signature

Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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

Follow-up F2 LeMLAR-Studie Lymphoma NCT01788189 - Follow-up F2

- 2016-10-06 - 1 Formulär, 2 Item-grupper, 131 Dataelement, 1 Språk

Item-grupper: follow up, clinical examination Diagnostic Imaging Manifestation of Lymphoma

Study part: Follow-up F2 LeMLAR-Studie. Lenalidomide in conjunction with methotrexate, leucovorin, cytarabine and rituximab for the treatment of relapsed or refractory CD20-positive aggressive lymphomas: an open-label, multicenter phase I/II trial. Publication granted by Prof. Dührsen and provided by Claudia Ose, University clinic Essen, NCT01788189, Version 1.3-28.04.2013.doc.

Vital Signs Follow- Up (Visit 10) Ropinirole Parkinson Disease 101468/165 - Vital Signs Follow- Up (Visit 10)

- 2021-09-27 - 1 Formulär, 1 Item-grupp, 10 Dataelement, 1 Språk

Item-grupp: Vital Signs

Study Part: Vital Signs Follow- Up (Visit 10). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Brief Physical Examination Follow- Up (Visit 10) Ropinirole Parkinson Disease 101468/165 - Brief Physical Examination Follow- Up (Visit 10)

- 2017-11-19 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk

Item-grupp: PHYSICAL EXAMINATION

Study Part: Brief Physical Examination Follow- Up (Visit 10). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

12 LEAD ECG Monitoring Follow- Up (Visit 10) Ropinirole Parkinson Disease 101468/165 - 12 LEAD ECG Monitoring Follow- Up (Visit 10)

- 2017-11-19 - 1 Formulär, 1 Item-grupp, 11 Dataelement, 1 Språk

Item-grupp: 12 LEAD ECG Monitoring

Study Part: 12 LEAD ECG Monitoring Follow- Up (Visit 10). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Follow-up visit week 38 physical examination Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 2017-10-17 - 1 Formulär, 2 Item-grupper, 7 Dataelement, 1 Språk

Item-grupper: administrative data, vital signs

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Physical Examination, Laboratory Results Hematology/ Chemistry Follow- Up

- 2022-01-31 - 1 Formulär, 8 Item-grupper, 44 Dataelement, 1 Språk

Item-grupper: Date of physical examination, Visit Week physical examination, B- Symptoms, Physical Examination, Organ/ System, Visit Week laboratory, Hematology, Chemistry

Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880 - Follow-Up Visit und Unscheduled Visit Form

- 2021-09-20 - 1 Formulär, 3 Item-grupper, 34 Dataelement, 1 Språk

Item-grupper: Administrative Data, Vital Signs, Physical Examination

This ODM file contains a form for the documention required at the follow-up and unscheduled visits. Study ID: 103880 Clinical Study ID: ARI103880 Study Title: An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Duagen,Zytefor,Avolve,Avodart,Avidart,Zyfetor; Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Prostatic Hyperplasia

Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758 - Follow-Up - Physical Examination; Laboratory Results; Post-Treatment Response

- 2021-04-01 - 1 Formulär, 16 Item-grupper, 59 Dataelement, 1 Språk

Item-grupper: Administrative, Physical Examination (Follow-Up), Physical Examination (Follow-Up), Laboratory Results - Hematology/ Chemistry (Follow-Up), Laboratory Results (Follow-Up) - Hematology, Laboratory Results (Follow-Up) - Hematology, Laboratory Results (Follow-Up) - Chemistry, Laboratory Results (Follow-Up) - Chemistry, Post-Treatment Response (Follow -Up), Post-Treatment Response (Follow-Up) - CT or other Radiological Imaging Results, Post-Treatment Response (Follow-Up) - Bone Marrow Biopsy, Post-Treatment Response (Follow-Up) - Measurable Lymphoma Disease, Post-Treatment Response (Follow-Up) - Non-Measurable Lymphoma Disease, Post-Treatment Response (Follow-Up) - Non-Measurable Lymphoma Disease, Post-Treatment Response (Follow-Up) - Response, Signature of Investigator

Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Physical Examination, Serum b-HCB Pregnancy Test, Vital Signs, 12-Lead ECG Monitoring

- 2017-08-05 - 1 Formulär, 4 Item-grupper, 26 Dataelement, 1 Språk

Item-grupper: phaysical examination, serum b-hcg pregnancy test, vital signs, 12-lead ecg monitoring

Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers 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: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Follow-Up Physical Examination, b-HCG Pregnancy Test, Vital Signs, 12-Lead ECG Monitoring

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