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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121305894 | 12130589 | 4 | F | 20160217 | 20160714 | 20160301 | 20160718 | EXP | JP-JNJFOC-20160225319 | JANSSEN | 80.66 | YR | E | M | Y | 54.00000 | KG | 20160718 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121305894 | 12130589 | 1 | PS | ZYTIGA | ABIRATERONE ACETATE | 1 | Oral | Y | N | 202379 | 1000 | MG | TABLET | QD | |||||
| 121305894 | 12130589 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous (not otherwise specified) | U | 0 | 220 | MG | INJECTION | QD | ||||||
| 121305894 | 12130589 | 3 | SS | TS-1 | GIMERACILOTERACILTEGAFUR | 1 | Oral | U | 0 | 40 | MG | TABLET | BID | ||||||
| 121305894 | 12130589 | 4 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 0 | 10 | MG | TABLET | QD | |||||||
| 121305894 | 12130589 | 5 | C | ABSTRAL | FENTANYL CITRATE | 1 | Sublingual | 0 | 100 | MG | TABLET | QD | |||||||
| 121305894 | 12130589 | 6 | C | FAMOTIDINE. | FAMOTIDINE | 1 | Oral | 0 | 10 | MG | TABLET | BID | |||||||
| 121305894 | 12130589 | 7 | C | MAGLAX | MAGNESIUM OXIDE | 1 | Oral | 0 | 330 | MG | TABLET | BID | |||||||
| 121305894 | 12130589 | 8 | C | ONBREZ | INDACATEROL | 1 | Respiratory (inhalation) | 0 | 1 | G | CAPSULE | QD | |||||||
| 121305894 | 12130589 | 9 | C | FENTOS | FENTANYL | 1 | Transdermal | 0 | 1 | MG | TAPE | QD | |||||||
| 121305894 | 12130589 | 10 | C | NAPROXEN. | NAPROXEN | 1 | Oral | 0 | 100 | MG | TABLET | TID | |||||||
| 121305894 | 12130589 | 11 | C | ARGAMATE | CALCIUM POLYSTYRENE SULFONATE | 1 | Oral | 0 | 25 | G | GEL | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121305894 | 12130589 | 1 | Hormone-refractory prostate cancer |
| 121305894 | 12130589 | 2 | Squamous cell carcinoma of lung |
| 121305894 | 12130589 | 3 | Squamous cell carcinoma of lung |
| 121305894 | 12130589 | 4 | Hormone-refractory prostate cancer |
| 121305894 | 12130589 | 5 | Cancer pain |
| 121305894 | 12130589 | 6 | Chronic gastritis |
| 121305894 | 12130589 | 7 | Constipation |
| 121305894 | 12130589 | 8 | Chronic obstructive pulmonary disease |
| 121305894 | 12130589 | 9 | Cancer pain |
| 121305894 | 12130589 | 10 | Tumour associated fever |
| 121305894 | 12130589 | 11 | Hyperkalaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121305894 | 12130589 | HO |
| 121305894 | 12130589 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121305894 | 12130589 | Haematuria | |
| 121305894 | 12130589 | Platelet count decreased | |
| 121305894 | 12130589 | Prostate cancer | |
| 121305894 | 12130589 | Squamous cell carcinoma of lung |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 121305894 | 12130589 | 1 | 20160204 | 20160216 | 0 | |
| 121305894 | 12130589 | 2 | 20160122 | 20160122 | 0 | |
| 121305894 | 12130589 | 3 | 20160122 | 20160204 | 0 | |
| 121305894 | 12130589 | 4 | 20160204 | 20160216 | 0 | |
| 121305894 | 12130589 | 5 | 20151207 | 0 | ||
| 121305894 | 12130589 | 6 | 20160222 | 0 | ||
| 121305894 | 12130589 | 7 | 20160222 | 0 | ||
| 121305894 | 12130589 | 8 | 20160222 | 0 | ||
| 121305894 | 12130589 | 9 | 20151207 | 20160221 | 0 | |
| 121305894 | 12130589 | 10 | 20151218 | 20160222 | 0 | |
| 121305894 | 12130589 | 11 | 20151225 | 20160222 | 0 |