Modèles de données sélectionnés

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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Investigator Comment Log, Patient Discharge Notification Postcard, Last Dose of Study Drug Record, End of Study Record, Status of Randomization Code/ Investigator's Statement and Laboratory Comments

- 08/10/2018 - 1 Formulaire, 9 Groupes Item, 34 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Clinical Investigators; Comment, Patient Discharge; Notifications, clinical trial drug; Dosage; Records; Last, Clinical Trials; End of protocol, Randomization; Code; Status | Clinical Investigators; Statement, Clinical Investigators; Statement, Laboratory; Comment | Evaluation; Laboratory; Unscheduled, Laboratory Results; Clinical Significance; Unexpected
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Protocol medication AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441 - Protocol medication AIEOP-BFM ALL 2009 NCT01117441

- 14/07/2016 - 1 Formulaire, 14 Groupes Item, 57 Eléments de données, 1 Langue
Groupes Item: Patient Information, First Element, Second Element, Third Element, Fourth Element, Fifth Element, Sixth Element, Seventh Element, Eighth Element, Ninth Element, Cranial radiation, Maintenance treatment, Comments, Identification and Signature
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Documentation of administered protocol medication Clinical Trial Number: NCT01117441.

Infanrix Vaccine - 102038 - Study Conclusion

- 11/03/2018 - 1 Formulaire, 4 Groupes Item, 16 Eléments de données, 1 Langue
Groupes Item: Header, Serious adverse event, Elimination criteria, Study Conclusion
Open, phase IV clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ Infanrix™ (DTPa) vaccine administered as a booster dose at 4 years of age in preterm vs. full-term children previously primed and boosted with Infanrix™ hexa.

Infanrix Vaccine - 102038 - Additional Forms

- 11/03/2018 - 1 Formulaire, 7 Groupes Item, 50 Eléments de données, 1 Langue
Groupes Item: Header, Report Swelling, Concomitant Vaccination, Concomitant vaccination, Medication, Medication, Non-serious Adverse Events
Open, phase IV clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ Infanrix™ (DTPa) vaccine administered as a booster dose at 4 years of age in preterm vs. full-term children previously primed and boosted with Infanrix™ hexa.

Infanrix Vaccine - 102038 - Visit 2

- 11/03/2018 - 1 Formulaire, 3 Groupes Item, 11 Eléments de données, 1 Langue
Groupes Item: Header, Check for Study Continuation, Laboratory Tests
Open, phase IV clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ Infanrix™ (DTPa) vaccine administered as a booster dose at 4 years of age in preterm vs. full-term children previously primed and boosted with Infanrix™ hexa.

Infanrix Vaccine - 102038 - Elegibility Questionnaire

- 04/03/2018 - 1 Formulaire, 3 Groupes Item, 16 Eléments de données, 1 Langue
Groupes Item: Elegibility Question, Inclusion Criteria, Exclusion Criteria
Open, phase IV clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ Infanrix™ (DTPa) vaccine administered as a booster dose at 4 years of age in preterm vs. full-term children previously primed and boosted with Infanrix™ hexa.

Infanrix Vaccine - 102038 - Visit 1

- 04/03/2018 - 1 Formulaire, 9 Groupes Item, 26 Eléments de données, 1 Langue
Groupes Item: Header, Informed consent, Demographics, Eligibility Criteria, General Medical History / Physical Examination, General medical history / physical examination, Pre-vaccination assessment, Vaccine Administration, Vaccine not administered
Open, phase IV clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ Infanrix™ (DTPa) vaccine administered as a booster dose at 4 years of age in preterm vs. full-term children previously primed and boosted with Infanrix™ hexa.

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