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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Slit lamp, Biomicrosopy, Visual acuity and indirect ophthalmoscopy

- 12.12.20 - 1 Formulär, 5 Item-grupper, 26 Dataelement, 1 Språk
Item-grupper: Administrative Data, slit lamp examination, slit lamp biomicroscopy, visual acuity, Indirect Ophtalmoscopy
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 Screening and Follow-Up Visits.

Indirect Ophthalmoscopy Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4170g - Indirect Ophthalmoscopy Screening

- 21.03.18 - 1 Formulär, 4 Item-grupper, 48 Dataelement, 1 Språk
Item-grupper: Indirect Ophthalmoscopy Right Eye, Indirect Ophthalmoscopy Left Eye , Retinal Break or Detachment right eye, Retinal Break or Detachment left eye
Study part: Indirect Ophthalmoscopy Screening. A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus.

Indirect Ophthalmoscopy Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4168g - Indirect Ophthalmoscopy Screening

- 21.03.18 - 1 Formulär, 4 Item-grupper, 48 Dataelement, 1 Språk
Item-grupper: Indirect Ophthalmoscopy Right Eye, Indirect Ophthalmoscopy Left Eye , Retinal Break or Detachment right eye, Retinal Break or Detachment left eye
Study part: Indirect Ophthalmoscopy Screening. A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus.

Indirect Ophthalmoscopy Screening Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Indirect Ophthalmoscopy Screening

- 18.03.18 - 1 Formulär, 4 Item-grupper, 52 Dataelement, 1 Språk
Item-grupper: Indirect Ophthalmoscopy Right Eye, Indirect Ophthalmoscopy Left Eye , Retinal Break or Detachment right eye, Retinal Break or Detachment left eye
Study part: Indirect Ophthalmoscopy Screening. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

Indirect Ophthalmoscopy Screening Ranibizumab Age-Related Macular Degeneration FVF3192g - Indirect Ophthalmoscopy Screening

- 22.02.18 - 1 Formulär, 4 Item-grupper, 22 Dataelement, 1 Språk
Item-grupper: Indirect Ophthalmoscopy Right Eye, Indirect Ophthalmoscopy Left Eye , Retinal Break or Detachment right eye, Retinal Break or Detachment left eye
Study part: Indirect Ophthalmoscopy Screening. A Phase IIIb, Multicenter, Randomized, Double-Masked, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab In Subjects With Subfoveal Choroidal Neovascular (CNV) With Or Without Classic CNV Secondary To Age-Related Macular Degeneration.

Indirect Ophthalmoscopy Month 3 rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2598g - Indirect Ophthalmoscopy Month 3

- 18.02.18 - 1 Formulär, 3 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Indirect Ophthalmoscopy Right Eye, Retinal Break or Detachment right eye, Retinal Break or Detachment left eye
Study part: Indirect Ophthalmoscopy Month 3. A Phase III, Multicenter, Randomized, Double-Masked, Sham Injection-Controlled Study Of The Efficacy And Safety Of rhuFab V2 (Ranibizumab) In Subjects With Minimally Classic Or Occult Subfoveal Neovascular Age-Related Macular Degeneration.

Indirect Ophthalmoscopy Day 0 rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2598g - Indirect Ophthalmoscopy Day 0

- 18.02.18 - 1 Formulär, 3 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Indirect Ophthalmoscopy Right Eye, Retinal Break or Detachment right eye, Retinal Break or Detachment left eye
Study part: Indirect Ophthalmoscopy Day 0. A Phase III, Multicenter, Randomized, Double-Masked, Sham Injection-Controlled Study Of The Efficacy And Safety Of rhuFab V2 (Ranibizumab) In Subjects With Minimally Classic Or Occult Subfoveal Neovascular Age-Related Macular Degeneration.

Indirect Ophthalmoscopy Screening rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2598g - Indirect Ophthalmoscopy Screening

- 18.02.18 - 1 Formulär, 4 Item-grupper, 22 Dataelement, 1 Språk
Item-grupper: Indirect Ophthalmoscopy Right Eye, Indirect Ophthalmoscopy Left Eye , Retinal Break or Detachment right eye, Retinal Break or Detachment left eye
Study part: Indirect Ophthalmoscopy Screening. A Phase III, Multicenter, Randomized, Double-Masked, Sham Injection-Controlled Study Of The Efficacy And Safety Of rhuFab V2 (Ranibizumab) In Subjects With Minimally Classic Or Occult Subfoveal Neovascular Age-Related Macular Degeneration.

Indirect Ophthalmoscopy Month 12 rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2587g - Indirect Ophthalmoscopy Month 12

- 04.02.18 - 1 Formulär, 3 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Indirect Ophthalmoscopy Right Eye, Retinal Break or Detachment right eye, Retinal Break or Detachment left eye
Study part: Indirect Ophthalmoscopy Month 12. A Phase III, Multicenter, Randomized, Double-Masked, Active Treatment-Controlled Study Of The Efficacy And Safety Of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne®) Photodynamic Therapy In Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration.

Indirect Ophthalmoscopy Month 11 rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2587g - Indirect Ophthalmoscopy Month 11

- 24.01.18 - 1 Formulär, 3 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Indirect Ophthalmoscopy Right Eye, Retinal Break or Detachment right eye, Retinal Break or Detachment left eye
Study part: Indirect Ophthalmoscopy Month 11. A Phase III, Multicenter, Randomized, Double-Masked, Active Treatment-Controlled Study Of The Efficacy And Safety Of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne®) Photodynamic Therapy In Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration.

Indirect Ophthalmoscopy Month 10 rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2587g - Indirect Ophthalmoscopy Month 10

- 24.01.18 - 1 Formulär, 3 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Indirect Ophthalmoscopy Right Eye, Retinal Break or Detachment right eye, Retinal Break or Detachment left eye
Study part: Indirect Ophthalmoscopy Month 10. A Phase III, Multicenter, Randomized, Double-Masked, Active Treatment-Controlled Study Of The Efficacy And Safety Of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne®) Photodynamic Therapy In Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration.

Indirect Ophthalmoscopy Month 9 rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2587g - Indirect Ophthalmoscopy Month 9

- 24.01.18 - 1 Formulär, 3 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Indirect Ophthalmoscopy Right Eye, Retinal Break or Detachment right eye, Retinal Break or Detachment left eye
Study part: Indirect Ophthalmoscopy Month 9. A Phase III, Multicenter, Randomized, Double-Masked, Active Treatment-Controlled Study Of The Efficacy And Safety Of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne®) Photodynamic Therapy In Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration.

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