Palabras clave
Helsesjekk ×
Mostrar más Palabras clave
Tabla de contenido
  1. 1. Ensayo clínico
  2. 2. Documentación de rutina
  3. 3. Estudio de registro / cohorte
  4. 4. Seguro de calidad
  5. 5. Estándar de datos
  6. 6. Resultado reportado por el paciente
  7. 7. Especialidad médica
Modelos de datos seleccionados

Debe iniciar sesión para seleccionar modelos de datos para descargar o realizar un análisis.

- 14/2/20 - 1 formulario, 12 itemgroups, 78 items, 1 idioma
Itemgroups: Conjunctival Exam , Corneal Exam , Anterior Chamber Exam , Lens Opacity , Fundus Exam , Optical Coherence Tomography , Fundus photographs and fluorescein angiography status , Randomisation Number, Treatment Regimen , Investigational Product (Eye Drops) - First Dose Date/ Time , Investigational Product (Eye Drops) - Dispensed, Eye Drop Administration
- 30/10/19 - 1 formulario, 19 itemgroups, 82 items, 1 idioma
Itemgroups: Administrative, Visit Date, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Results, ECG Findings, Hematology, Hematology , Clinical Chemistry, Coagulation and Electrolytes, Clinical Chemistry, Coagulation and Electrolytes , Urinalysis dipstick results, Urinalysis microscopy results, Urinalysis microscopy results , Serum beta-hCG Pregnancy Test, PK Sampling - Plasma Samples, Study Treatment Compliance (Return) , New Adverse Events and Concomitant Treatment
- 17/10/19 - 1 formulario, 3 itemgroups, 28 items, 1 idioma
Itemgroups: Administrative documentation, Large Swelling Reaction - Report of physical examination, Large swelling reaction - Clinical case desciption and outcome of the adverse event
Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form contains information on a large swelling reaction and is to be filled in at the Interim Analysis at/after Visit 6 and at the End of Study Analysis at/after Visit 10. Please complete this form for: (a) any local swelling with diameter > 50 mm, and/or (b) any noticeable diffuse injection site swelling (diameter not measurable), and/or (c) any noticeable increased circumference of the injected limb. If hospitalization is required, a Serious Adverse Event (SAE) form is to be completed as well and send to the sponsor (GlaxoSmithKline Biologicals) within 24 hours after becoming aware of the SAE.

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial