Person who experienced the adverse event (patient)
Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126283691 | 12628369 | 1 | I | 20160801 | 20160808 | 20160808 | EXP | NL-HORIZON-PRE-0241-2016 | HORIZON | MANENSCHIJN L, HAMBERG P. PROLONGED BIOCHEMICAL RESPONSE AFTER DISCONTINUATION OF ORTERONEL (TAK-700) IN A PATIENT WITH METASTASIZED CASTRATION-RESISTANT PROSTATE CANCER. ACTA ONCOL. 2016;55(5):656-8. | 73.00 | YR | E | M | Y | 0.00000 | 20160805 | MD | NL | NL |
Drug(s) used by person
Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126283691 | 12628369 | 1 | PS | PREDNISONE. | PREDNISONE | 1 | 5 MG BID | Y | 202020 | 5 | MG | BID | |||||||
126283691 | 12628369 | 2 | SS | Orteronel | ORTERONEL | 1 | 400 MG BID | Y | Y | 0 | 400 | MG | BID |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126283691 | 12628369 | 1 | Hormone-refractory prostate cancer |
126283691 | 12628369 | 2 | Hormone-refractory prostate cancer |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126283691 | 12628369 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126283691 | 12628369 | Fatigue |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |