Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union

Health and Quality of Life Outcomes

Volumn 12, Issue 1, 2014, Pages

  Clark, Marci J ^a   Harris, Nimanee ^a   Griebsch, Ingolf ^b   Kaschinski, Dagmar ^b   Copley Merriman, Catherine ^a  

^a RTI HEALTH SOLUTIONS   (United States)

^b BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

European medicines agency; Food and drug administration; Labeling; Metastatic castration resistant prostate cancer; Patient reported outcomes; Questionnaires; Treatment

Indexed keywords

ABIRATERONE; CABAZITAXEL; ENZALUTAMIDE; RADIUM CHLORIDE RA 223; SIPULEUCEL T; ANTINEOPLASTIC AGENT;

ADMINISTRATIVE CLAIMS (HEALTH CARE); ARTICLE; BRIEF PAIN INVENTORY; CASTRATION RESISTANT PROSTATE CANCER; CONSTRUCT VALIDITY; CONTENT VALIDITY; DRUG APPROVAL; DRUG LABELING; DRUG MANUFACTURE; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; HUMAN; MC GILL PAIN QUESTIONNAIRE INTENSITY; METASTASIS POTENTIAL; OUTCOME ASSESSMENT; PAIN INTENSITY; PSYCHOLOGICAL ASPECT; PSYCHOMETRY; QUALITY OF LIFE; QUESTIONNAIRE; RELIABILITY; SOCIAL ASPECT; UNITED STATES; VISUAL ANALOG SCALE; COMPARATIVE STUDY; COMPLICATION; DRUG SURVEILLANCE PROGRAM; EVALUATION STUDY; HEALTH STATUS INDICATOR; MALE; METASTASIS; MIDDLE AGED; PAIN; PAIN MEASUREMENT; PATHOLOGY; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; PSYCHOLOGY; REPRODUCIBILITY; SELF REPORT;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTINEOPLASTIC AGENTS; DRUG LABELING; EUROPEAN UNION; HEALTH STATUS INDICATORS; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PAIN; PAIN MEASUREMENT; PATIENT OUTCOME ASSESSMENT; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT; PSYCHOMETRICS; QUALITY OF LIFE; REPRODUCIBILITY OF RESULTS; SELF REPORT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84904274142     PISSN: None     EISSN: 14777525     Source Type: Journal    
DOI: 10.1186/s12955-014-0104-5     Document Type: Article

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