Safety of gadobutrol: Results from 42 clinical phase II to IV studies and postmarketing surveillance after 29 million applications

Investigative Radiology

Volumn 51, Issue 9, 2016, Pages 537-543

  Endrikat, Jan ^a,b   Vogtlaender, Kai ^a   Dohanish, Susan ^c   Balzer, Thomas ^d   Breuer, Josy ^a  

^a BAYER PHARMA AG   (Germany)

^b University Medical School of Saarland Homburg   (Germany)

^c Global Pharmacovigilance and Risk Management   (Germany)

^d Pharmacovigilance and Risk Management   (United States)

Author keywords

Contrast agent; Gadobutrol; GBCA; MRI; Safety

Indexed keywords

CONTRAST MEDIUM; GADOBUTROL; GADODIAMIDE; GADOLINIUM PENTETATE MEGLUMINE; GADOTERATE MEGLUMINE; GADOTERIDOL; GADOVERSETAMIDE; ORGANOMETALLIC COMPOUND;

ALLERGIC REACTION; ARTICLE; DIZZINESS; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DYSGEUSIA; DYSPNEA; ERYTHEMA; GROUPS BY AGE; HEADACHE; HUMAN; HYPERSENSITIVITY; INJECTION SITE REACTION; INTERVENTION STUDY; MEDICAL HISTORY; NAUSEA; NEPHROGENIC SYSTEMIC FIBROSIS; PARESTHESIA; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PRURITUS; RASH; RETROSPECTIVE STUDY; SYSTEMATIC REVIEW; VOMITING; ADOLESCENT; ADULT; AGE DISTRIBUTION; AGED; CHEMICALLY INDUCED; CHILD; CLINICAL TRIAL; FACTUAL DATABASE; FEMALE; INCIDENCE; INFANT; MALE; MIDDLE AGED; NEWBORN; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PHASE 4 CLINICAL TRIAL; PRESCHOOL CHILD; STATISTICS AND NUMERICAL DATA; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGE DISTRIBUTION; AGED; AGED, 80 AND OVER; CHILD; CHILD, PRESCHOOL; CONTRAST MEDIA; DATABASES, FACTUAL; FEMALE; HUMANS; INCIDENCE; INFANT; INFANT, NEWBORN; MALE; MIDDLE AGED; NEPHROGENIC FIBROSING DERMOPATHY; ORGANOMETALLIC COMPOUNDS; PRODUCT SURVEILLANCE, POSTMARKETING; YOUNG ADULT;

EID: 84960459282     PISSN: 00209996     EISSN: 15360210     Source Type: Journal    
DOI: 10.1097/RLI.0000000000000270     Document Type: Article

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