Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos
5. december 2016 opdateret af: Pfizer
A Non-interventional Study Of The Safety Of Pneumococcal 13-valent Conjugate Vaccine (Prevenar 13) In The Philippines: A Post Marketing Surveillance Study
Prevenar 13 is safe for administration to Filipinos.
Studieoversigt
Detaljeret beskrivelse
Filipino patients prescribed and administered with the vaccine will be monitored for safety Patients prescribed with the vaccine who provides consent for inclusion to the study will be observed.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
3006
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Angeles City, Filippinerne
- Private Clinic
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Antipolo City, Filippinerne
- Private Clinic
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Bacolod CIty, Filippinerne
- Medical Arts Building
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Bacolod City, Filippinerne, 6100
- Dr. Pablo O. Torre Memorial Medical Center
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Bacolod City, Filippinerne
- Medical Plaza
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Bacolod City, Filippinerne
- Private Clinic
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Bacolod City, Filippinerne
- Riverside Medical Center
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Bacolod City, Filippinerne
- Room 302 Medical Arts Building
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Bacolod City, Filippinerne
- Room 311 Riverside Medical Arts Building
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Bacolod City, Filippinerne
- Villanueva Laboratory and Clinics
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Batangas, Filippinerne
- Private Clinic
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Batangas, Filippinerne
- MCA Bauanan Children's Clinic
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Batangas City, Filippinerne
- Private Clinic
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Binondo, Manila, Filippinerne
- Metropolitan Medical Center
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Bocaue, Filippinerne
- Private Clinic
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Bulacan, Filippinerne
- Private Clinic
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Bulacan, Filippinerne
- 417
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Bulacan, Filippinerne
- Clinica Tapia
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Bulacan, Filippinerne
- Pediatric Doctor's Clinic
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Bulacan, Filippinerne
- St Vincent's Wellness Clinic
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Cagayan De Oro City, Filippinerne
- Room 11
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Caloocan City, Filippinerne
- Centralle Medical Diagnostics and Polyclinic
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Caloocan City, Filippinerne
- Private Clinic
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Candelaria City, Filippinerne
- Private Clinic
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Capiz City, Filippinerne
- Blk 19 Lot 11
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Cavite, Filippinerne
- Private Clinic
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Cebu, Filippinerne
- Chong Hua Hospital
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Cebu, Filippinerne, 6000
- Cebu Doctor University Hospital
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Cebu, Filippinerne, 6000
- Chong Hua Hospital
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Cebu City, Filippinerne
- Private Clinic
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Cebu City, Filippinerne
- Chong Hua Hospital
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Cebu City, Filippinerne
- Basement
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Cebu City, Filippinerne
- Care and Cure Hub
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Cebu City, Filippinerne
- Cebu Doctors University Hopsital
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Cebu City, Filippinerne
- PPG, Manila, Philippines
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Cebu City, Filippinerne
- Rm4A, Medical Arts Building
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Cebu City, Filippinerne
- Room 302-A
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Cebu City, Filippinerne
- Room 413 Medical Arts Building 2
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Cebu City, Filippinerne
- Room 419 SPC Medical Specialty Center
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Cebu City, Filippinerne
- Room 505A Chong Hua Medical Arts Building
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Dagupan City, Filippinerne
- Private Clinic
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Davao City, Filippinerne
- Private Clinic
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Davao City, Filippinerne
- Community Health and Development Cooperative Hospital
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Davao City, Filippinerne
- Health Science and Wellness Center
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Davao City, Filippinerne
- Jesusa Complex
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Davao City, Filippinerne
- San Pedro Hospital Inc.
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Davao City, Filippinerne
- San Pedro Hospital
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Dipolog City, Filippinerne
- Private Clinic
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Dumaguete City, Filippinerne
- Private Clinic
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Dumaguete City, Filippinerne
- Room 117 Medical Arts Building
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Iligan City, Filippinerne
- Iligan Specialist Clinic
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Iloilo City, Filippinerne
- Private Clinic
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Koronadal City, Filippinerne
- Private Clinic
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Laguna, Filippinerne
- Private Clinic
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Las Pinas City, Filippinerne
- Las Piñas Doctors Hospital
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Legaspi City, Filippinerne
- Private Clinic
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Lipa City, Filippinerne
- Private Clinic
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Lucena City, Filippinerne
- Lucena United Doctors Hospital
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Lucena City, Filippinerne
- Private Clinic
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Makati City, Filippinerne
- Private Clinic
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Malabon, Filippinerne
- Tumbicon Polycare
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Malabon City, Filippinerne
- Archangel Raphael Pediatric Clinic
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Malabon City, Filippinerne
- Children's Clinic
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Malabon City, Filippinerne
- Malabon Medical Clinic
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Malolos City, Filippinerne
- Private Clinic
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Mandaluyong City, Filippinerne
- Private Clinic
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Manila, Filippinerne
- Private Clinic
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Manila, Filippinerne, 1000
- Metropolitan Medical Center
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Manila, Filippinerne
- 1952
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Manila, Filippinerne
- Children's Clinic
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Manila, Filippinerne
- Chinese General Hospital
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Manila, Filippinerne
- Rm714B
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Manila, Filippinerne
- Room 210, Metropolitan Medical Center
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Manila, Filippinerne
- Room 706
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Marikina City, Filippinerne
- Private Clinic
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Marikina City, Filippinerne, 1801
- Marikina Valley Medical Center
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Marikina City, Filippinerne
- Centro Medical and Laboratory Clinic
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Marikina City, Filippinerne
- Garcia General Hospital
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Marikina City, Filippinerne
- Room 605
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Negors Occidental, Filippinerne
- Private Clinic
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Negros Occidental, Filippinerne
- Private Clinic
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Pampanga, Filippinerne
- Mabalacat Child Care Clinic
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Pangasinan, Filippinerne
- Private Clinic
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Paranaque, Filippinerne
- Maglana Villamor Clinic
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Paranaque, Filippinerne
- Paranaque Doctors Hospital
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Pasig, Filippinerne
- Private Clinic
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Pasig City, Filippinerne
- Private Clinic
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Quezon, Filippinerne
- Private Clinic
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Quezon, Filippinerne
- Emil-Joanna General Hospital
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Quezon CIty, Filippinerne
- Madrid Polyclinic
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Quezon City, Filippinerne, 1100
- Philippine Heart Center
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Quezon City, Filippinerne
- Private Clinic
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Quezon City, Filippinerne
- Friendly Care Clinic
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Quezon City, Filippinerne
- Maternity and Children's Clinic
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Quezon City, Filippinerne
- Medical Specialist Clinic
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Quezon City, Filippinerne
- Natividad Children's Clinic
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Quezon City, Filippinerne
- Philippine Heart Center
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Quezon City, Filippinerne
- Room 11
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Quezon City, Filippinerne
- World Citi Medical Center
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Rizal, Filippinerne
- Children's Clinic
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Rizal, Filippinerne
- Private Clinic
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San Pablo City, Filippinerne
- Community General Hospital
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San Pablo City, Filippinerne
- Private Clinic
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South Luzon, Filippinerne
- Private Clinic
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Sta. Cruz, Manila, Filippinerne
- Chinese General Hospital and Medical Center
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Tagbilaran City, Filippinerne
- Private Clinic
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Tarlac City, Filippinerne
- Private Clinic
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Urdaneta City, Filippinerne
- Private Clinic
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Valenzuela City, Filippinerne
- Private Clinic
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Zamboanga City, Filippinerne
- Private Clinic
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Zamboanga City, Filippinerne
- Room 331
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Batangas
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Lipa City, Batangas, Filippinerne
- Private Clinic
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Bohol
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Tagbilaran City, Bohol, Filippinerne
- Private Clinic
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Bulacan
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Malolos, Bulacan, Filippinerne
- Private Clinic
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Negros Occidental
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Bacolod City, Negros Occidental, Filippinerne
- Room 220 The Doctor's Hospital, Inc.
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San Carlos City, Negros Occidental, Filippinerne
- Private Clinic
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San Carlos City, Negros Occidental, Filippinerne
- San Carlos Doctor's Hospital
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Victorias City, Negros Occidental, Filippinerne
- Victorias Commercial Center
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Pangasinan
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Dagupan City, Pangasinan, Filippinerne
- Private Clinic
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Mangaldan, Pangasinan, Filippinerne
- Private Clinic
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Pozorrubio, Pangasinan, Filippinerne
- Private Clinic
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 måned og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Filipino patients prescribed with the vaccine
Beskrivelse
Inclusion Criteria:
Patients prescribed with the vaccine
Exclusion Criteria:
Patients with hypersensitivity to the vaccine
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Prevenar 13 patients
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Prevenar 13 vaccine as prescribed by the physician based on approved product indication
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period
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All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported.
An AE was any untoward medical occurrence in a participant who received 13vPnC.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
AEs included both SAEs and non-SAEs.
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Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2011
Primær færdiggørelse (Faktiske)
1. maj 2014
Studieafslutning (Faktiske)
1. maj 2014
Datoer for studieregistrering
Først indsendt
22. juni 2011
Først indsendt, der opfyldte QC-kriterier
15. juli 2011
Først opslået (Skøn)
18. juli 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. januar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. december 2016
Sidst verificeret
1. januar 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B1851076
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .