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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037 - Splenectomy status

- 16-10-19 - 1 Formulier, 2 Itemgroepen, 4 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Splenectomy status
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 Splenectomy status form. It has to be filled in for Day 1.

Accident repot form Pediatric surgery UKM - Accident repot form

- 01-06-17 - 1 Formulier, 1 Itemgroep, 15 Data-elementen, 2 Talen
Itemgroep: Admission Type - Accident
Accident repot form converted to ODM format. Routine documentation of University Hospital of Münster. Publication granted by Dr. med. V. Müller

Operative report, Ophthalmology, University Hospital Cologne

- 01-05-17 - 1 Formulier, 1 Itemgroep, 13 Data-elementen, 1 Taal
Itemgroep: Operative report ophthalmology
Hospital Routine Documentation Subform at the University Hospital Cologne. Original Form name: OP_Bericht_AUG

OPAP Protocol Print University Hospital Cologne

- 31-03-17 - 1 Formulier, 1 Itemgroep, 9 Data-elementen, 1 Taal
Itemgroep: surgery protocol
Hospital Routine Documentation Subform at the University Hospital Cologne. Original Form name: OPAP Protokolldruck

OPAP Protocol University Hospital Cologne

- 29-03-17 - 1 Formulier, 1 Itemgroep, 25 Data-elementen, 1 Taal
Itemgroep: OPAP Protocol
Hospital Routine Documentation Subform at the University Hospital Cologne. Original Form name: OPAP Protokoll 01

OP MS Patbegl Std Sub Sub University Hospital Muenster (UKM) Subform

- 01-12-16 - 1 Formulier, 1 Itemgroep, 6 Data-elementen, 1 Taal
Itemgroep: Post-surgical information
Hospital Routine Documentation Subform at the University Hospital Muenster. Original Form name: OP MS Patbegl Std Sub Sub.

AB MS PÄD Intensiv University Hospital Muenster (UKM) Subform

- 23-11-16 - 1 Formulier, 8 Itemgroepen, 36 Data-elementen, 1 Taal
Itemgroepen: Diagnosis, Ventilation, Newborn, Surgery, Anamnesis and findings, Therapy and progress, Recommendation, Stay
Hospital Routine Documentation Subform at the University Hospital Muenster. Original Form name: AB MS PÄD Intensiv.

OPPL OP MS AUGE Sub University Hospital Muenster (UKM) Subform

- 17-11-16 - 1 Formulier, 1 Itemgroep, 8 Data-elementen, 1 Taal
Itemgroep: Preparation of surgery
Original Form name: Hospital Routine Documentation Subform at the University Hospital Muenster. Original Form name: OPPL OP MS AUGE Sub.

AB MS PÄD Säugl_Neugeb_Stat University Hospital Muenster (UKM) Subform

- 20-10-16 - 1 Formulier, 7 Itemgroepen, 31 Data-elementen, 1 Taal
Itemgroepen: Diagnosis, Newborn, Surgery, Anamnesis and findings, Therapy and progress, Recommendation, Stay
Hospital Routine Documentation Subform at the University Hospital Muenster. Original Form name: AB MS PÄD Säugl_Neugeb_Stat.

Photo documentation General surgery Operation photo documentation Routine documentation in German hospitals DMI - Photo documentation General surgery Operation photo documentation

- 15-05-16 - 1 Formulier, 1 Itemgroep, 7 Data-elementen, 1 Taal
Itemgroep: Photo documentation
Routine documentation in German hospitals. Source file name: OP150104_OP-Bilddokumentation/ Fotodokumentation.059 Examplary forms provided by DMI (http://www.dmi.de/)

GOG-0218 Surgical Reporting Form NCT00262847

- 27-06-15 - 1 Formulier, 4 Itemgroepen, 22 Data-elementen, 1 Taal
Itemgroepen: HEADER MODULE, Surgery assessment, Gynecologic involvement, FOOTER MODULE
GOG-0218 Surgical Reporting Form NCT00262847 Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal Cancer, or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F11BB717-3E92-5D5B-E034-0003BA3F9857

NCT00565851 GYNECOLOGIC ONCOLOGY GROUP Surgical Reporting Form - FORM C

- 27-06-15 - 1 Formulier, 3 Itemgroepen, 24 Data-elementen, 1 Taal
Itemgroepen: Patient demographics, Surgery assessment, Comments
NCT00565851 GYNECOLOGIC ONCOLOGY GROUP Surgical Reporting Form - FORM C Carboplatin and Paclitaxel With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DA3F6FCF-2BF6-2D9B-E034-0003BA12F5E7

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