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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125205341 | 12520534 | 1 | I | 201606 | 20160620 | 20160701 | 20160701 | EXP | GB-MHRA-EYC 00141114 | GB-DRREDDYS-GER/UKI/16/0080855 | DR REDDYS | 83.00 | YR | M | Y | 0.00000 | 20160701 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125205341 | 12520534 | 1 | PS | Zoledronic acid | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | U | UNKNOWN | 91186 | |||||||||
| 125205341 | 12520534 | 2 | C | CHLORHEXIDINE GLUCONATE. | CHLORHEXIDINE GLUCONATE | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 3 | C | COLECALCIFEROL | CHOLECALCIFEROL | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 4 | C | CYCLIZINE | CYCLIZINE | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 5 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 6 | C | FENTANYL. | FENTANYL | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 7 | C | FLAVOXATE HYDROCHLORIDE. | FLAVOXATE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 8 | C | FLUDROCORTISONE | FLUDROCORTISONE | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 9 | C | FRAGMIN | DALTEPARIN SODIUM | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 10 | C | HALOPERIDOL. | HALOPERIDOL | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 11 | C | LANSOPRAZOL | LANSOPRAZOLE | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 12 | C | LAXIDO | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 13 | C | LEVOMEPROMAZINE | LEVOMEPROMAZINE | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 14 | C | MATRIFEN | FENTANYL | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 15 | C | NYSTATIN. | NYSTATIN | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 16 | C | ORAMORPH | MORPHINE SULFATE | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 17 | C | PARACETAMOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 18 | C | PROCHLORPERAZINE. | PROCHLORPERAZINE | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 19 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125205341 | 12520534 | 20 | C | ENZALUTAMIDE | ENZALUTAMIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125205341 | 12520534 | 1 | Prostate cancer metastatic |
| 125205341 | 12520534 | 2 | Product used for unknown indication |
| 125205341 | 12520534 | 3 | Product used for unknown indication |
| 125205341 | 12520534 | 4 | Product used for unknown indication |
| 125205341 | 12520534 | 5 | Product used for unknown indication |
| 125205341 | 12520534 | 6 | Product used for unknown indication |
| 125205341 | 12520534 | 7 | Product used for unknown indication |
| 125205341 | 12520534 | 8 | Product used for unknown indication |
| 125205341 | 12520534 | 9 | Product used for unknown indication |
| 125205341 | 12520534 | 10 | Product used for unknown indication |
| 125205341 | 12520534 | 11 | Product used for unknown indication |
| 125205341 | 12520534 | 12 | Product used for unknown indication |
| 125205341 | 12520534 | 13 | Product used for unknown indication |
| 125205341 | 12520534 | 14 | Product used for unknown indication |
| 125205341 | 12520534 | 15 | Product used for unknown indication |
| 125205341 | 12520534 | 16 | Product used for unknown indication |
| 125205341 | 12520534 | 17 | Product used for unknown indication |
| 125205341 | 12520534 | 18 | Product used for unknown indication |
| 125205341 | 12520534 | 19 | Product used for unknown indication |
| 125205341 | 12520534 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125205341 | 12520534 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125205341 | 12520534 | Exposed bone in jaw | |
| 125205341 | 12520534 | Mucosal inflammation | |
| 125205341 | 12520534 | Oral disorder | |
| 125205341 | 12520534 | Oroantral fistula | |
| 125205341 | 12520534 | Osteonecrosis of jaw |
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 |
|---|---|---|---|---|---|---|
| 125205341 | 12520534 | 1 | 201503 | 0 |