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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124288394 | 12428839 | 4 | F | 20160413 | 20160915 | 20160602 | 20160922 | EXP | JP-JNJFOC-20160527198 | JANSSEN | 82.99 | YR | E | M | Y | 52.00000 | KG | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124288394 | 12428839 | 1 | PS | ZYTIGA | ABIRATERONE ACETATE | 1 | Oral | Y | N | UNKNOWN | 202379 | 750 | MG | TABLET | QD | ||||
| 124288394 | 12428839 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | Y | 0 | 10 | MG | TABLET | QD | ||||||
| 124288394 | 12428839 | 3 | C | GONAX | DEGARELIX | 1 | Subcutaneous | D | 0 | 80 | MG | INJECTION | QD | ||||||
| 124288394 | 12428839 | 4 | C | RANMARK | DENOSUMAB | 1 | Subcutaneous | D | 0 | 120 | MG | INJECTION | QD | ||||||
| 124288394 | 12428839 | 5 | C | TAKEPRON | LANSOPRAZOLE | 1 | Oral | D | 0 | 30 | MG | TABLET | QD | ||||||
| 124288394 | 12428839 | 6 | C | TAKEPRON | LANSOPRAZOLE | 1 | Oral | D | 0 | 15 | MG | TABLET | QD | ||||||
| 124288394 | 12428839 | 7 | C | KETAS | IBUDILAST | 1 | Oral | D | 0 | 10 | MG | CAPSULE | BID | ||||||
| 124288394 | 12428839 | 8 | C | PURSENNID | SENNOSIDES A AND B | 1 | Oral | D | 0 | UNSPECIFIED | |||||||||
| 124288394 | 12428839 | 9 | C | MAGMITT | MAGNESIUM OXIDE | 1 | Oral | D | 0 | 250 | MG | TABLET | TID | ||||||
| 124288394 | 12428839 | 10 | C | EQUA | VILDAGLIPTIN | 1 | Oral | D | 0 | 50 | MG | TABLET | QD | ||||||
| 124288394 | 12428839 | 11 | C | BAYASPIRIN | ASPIRIN | 1 | Oral | D | 0 | 100 | MG | TABLET | QD | ||||||
| 124288394 | 12428839 | 12 | C | AMLODIN | AMLODIPINE BESYLATE | 1 | Oral | D | 0 | 5 | MG | TABLET | BID | ||||||
| 124288394 | 12428839 | 13 | C | DENOTAS | CALCIUM CARBONATECHOLECALCIFEROLMAGNESIUM CARBONATE | 1 | Oral | D | 0 | TABLET | |||||||||
| 124288394 | 12428839 | 14 | C | FENTOS | FENTANYL | 1 | Transdermal | D | 0 | 1 | MG | TAPE | QD | ||||||
| 124288394 | 12428839 | 15 | C | TERPERAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Oral | D | 0 | 5 | MG | TABLET | TID | ||||||
| 124288394 | 12428839 | 16 | C | TERPERAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Oral | D | 0 | 5 | MG | TABLET | TID | ||||||
| 124288394 | 12428839 | 17 | C | AMITIZA | LUBIPROSTONE | 1 | Oral | D | 0 | 24 | MG | CAPSULE | BID | ||||||
| 124288394 | 12428839 | 18 | C | DIART | AZOSEMIDE | 1 | Oral | D | 0 | 30 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124288394 | 12428839 | 1 | Hormone-refractory prostate cancer |
| 124288394 | 12428839 | 2 | Hormone-refractory prostate cancer |
| 124288394 | 12428839 | 3 | Hormone-refractory prostate cancer |
| 124288394 | 12428839 | 4 | Metastases to bone |
| 124288394 | 12428839 | 5 | Gastrointestinal ulcer |
| 124288394 | 12428839 | 6 | Gastrointestinal ulcer |
| 124288394 | 12428839 | 7 | Cerebral haemorrhage |
| 124288394 | 12428839 | 8 | Product used for unknown indication |
| 124288394 | 12428839 | 9 | Constipation |
| 124288394 | 12428839 | 10 | Diabetes mellitus |
| 124288394 | 12428839 | 11 | Cardiac valve disease |
| 124288394 | 12428839 | 12 | Hypertension |
| 124288394 | 12428839 | 13 | Product used for unknown indication |
| 124288394 | 12428839 | 14 | Cancer pain |
| 124288394 | 12428839 | 15 | Vomiting |
| 124288394 | 12428839 | 16 | Nausea |
| 124288394 | 12428839 | 17 | Constipation |
| 124288394 | 12428839 | 18 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124288394 | 12428839 | DE |
| 124288394 | 12428839 | HO |
| 124288394 | 12428839 | LT |
| 124288394 | 12428839 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124288394 | 12428839 | Cholecystitis acute | |
| 124288394 | 12428839 | Haemoglobin decreased | |
| 124288394 | 12428839 | Haemorrhoids | |
| 124288394 | 12428839 | Hyponatraemia | |
| 124288394 | 12428839 | Off label use | |
| 124288394 | 12428839 | Platelet count decreased | |
| 124288394 | 12428839 | Prescribed underdose | |
| 124288394 | 12428839 | Prostate cancer | |
| 124288394 | 12428839 | Rectal ulcer | |
| 124288394 | 12428839 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 124288394 | 12428839 | 1 | 20160413 | 20160509 | 0 | |
| 124288394 | 12428839 | 2 | 20160413 | 0 | ||
| 124288394 | 12428839 | 3 | 20150609 | 0 | ||
| 124288394 | 12428839 | 4 | 20150609 | 0 | ||
| 124288394 | 12428839 | 5 | 20150609 | 0 | ||
| 124288394 | 12428839 | 6 | 20160413 | 0 | ||
| 124288394 | 12428839 | 13 | 20150609 | 0 | ||
| 124288394 | 12428839 | 14 | 20160420 | 0 | ||
| 124288394 | 12428839 | 15 | 20160420 | 0 | ||
| 124288394 | 12428839 | 16 | 20160420 | 0 | ||
| 124288394 | 12428839 | 17 | 20160430 | 0 |