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Effect of GSK958108 on ejaculatory latency time (ELT); NCT00861484 - Follow-up

- 06.06.20 - 1 Formular, 14 Itemgruppen, 167 Datenelemente, 1 Sprache
Itemgruppen: Date of visit, Vital signs, 12 lead ECG, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Urinalysis, Laboratory Procedures, Hormones, Laboratory Procedures, Free Testosterone Measurement, Laboratory Procedures, Prolactin measurement, Nervous system structure, Evaluation, Ophthalmic examination and evaluation, Blinded Clinical Study, Status, Pregnancy, Information, Conclusion, Clinical Research
Study ID: 111155 Clinical Study ID: 111155 Study Title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00861484 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK958108 , Placebo Trade Name: N/A Study Indication: Premature Ejaculation

Status of treatment blind Pazopanib Macular Degeneration MD1103367 - Status of treatment blind

- 20.09.21 - 1 Formular, 1 Itemgruppe, 4 Datenelemente, 1 Sprache
Itemgruppe: Treatment Status; Blinded Clinical Study
Study part: Status of treatment blind. 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.

Study Conclusion Pazopanib Macular Degeneration MD1103367 - Study Conclusion

- 20.09.21 - 1 Formular, 1 Itemgruppe, 5 Datenelemente, 1 Sprache
Itemgruppe: Study Conclusion
Study part: Study Conclusion. 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.

Study Completion/ Early Discontinuation rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2598g - Study Completion/ Early Discontinuation

- 18.02.18 - 1 Formular, 1 Itemgruppe, 8 Datenelemente, 1 Sprache
Itemgruppe: Study Completion
Study part: Study Completion/ Early Discontinuation. 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.

ICHOM Paediatric Facial Palsy - End of pediatric or planned care - Clinical Form

- 30.04.20 - 1 Formular, 4 Itemgruppen, 25 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Patient Demographic Factors, Clinical Status, Degree of Health
ICHOM Paediatric Facial Palsy data collection Version 1.0.0 Revised: August 31st, 2018 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. For Paediatric Facial Palsy, the following conditions and treatment approaches (or interventions) are covered by ICHOM‘s Standard Set. Conditions: Congenital/Syndromic | Acquired Unilateral (single- and multi-territory) | Bilateral (single- and multi-territory) Treatment approaches: Medical treatment | Surgery | Eye care Physiotherapy/Occupational therapy | Botulinum toxin | Psychological support This document contains the End of pediatric or planned care - Clinical Form. It should be completed at the end of paediatric care (16y to 18y) or when no further treatments are planned, and allow for >1 year follow-up. Collecting Patient-Reported Outcome Measure: eFACE – Clinician. For more information see: Banks CA, Bhama PK, Park J, Hadlock CR, Hadlock TA. Clinician-Graded Electronic Facial Paralysis Assessment: The eFACE, August 2015. doi: 10.1097/PRS.0000000000001447 FACE-Q Kids. As there is a license for use of this questionnaire, the questions will not be included in this version of the standard set, only subscores. Snellen Chart – Clinician. PROMIS Paediatric Global Health 7 and PROMIS Pediatric Peer Relationships SF 8a. As there is an official distribution site, only the total score of these questionnaires will be included in this version of the standard set. For more information see: http://www. healthmeasures.net/explore-measurement-systems/promis/ obtain-administer-measures Reference: Butler DP, De la Torre A, Borschel GH, et al. An International Collaborative Standardizing Patient-Centered Outcome Measures in Pediatric Facial Palsy. JAMA Facial Plast Surg. Published online May 09, 2019. doi:10.1001/jamafacial.2019.0224 The Standard set of ICHOM was supported by the royal free charity and the Dianne and Michael Bienes Charitable Foundation Inc. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037 - End of treatment/Early withdrawal, Unscheduled visit assessments; discontinuation of investigational product

- 05.12.19 - 1 Formular, 3 Itemgruppen, 20 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Early withdrawal or unscheduled assessments, Investigational product discontinuation
Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the End of treatment/Early withdrawal and unscheduled visit assessments forms as well as information on discontinuation of the investigational product.

Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037 - Study conclusion, Pregnancy information

- 26.11.19 - 1 Formular, 5 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Study conclusion, Pregnancy information (female), Pregnancy information (male), Case book signature
Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the study conclusion and pregnancy information form. It has to be filled in for the end of study.

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