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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127560102 | 12756010 | 2 | F | 20160927 | 20160916 | 20160928 | EXP | GR-JNJFOC-20160913515 | JANSSEN | MALAGARI K, THEODOROS K, MARIA P, HIPPOKRATIS M, EMMANOUIL E, THEMIS S, ET AL. PHARMACOKINETICS, SAFETY, AND EFFICACY OF CHEMOEMBOLIZATION WITH DOXORUBICIN-LOADED TIGHTLY CALIBRATED SMALL MICROSPHERES IN PATIENTS WITH HEPATOCELLULAR CARCINOMA. CARDIOVASCULAR + INTERVENTIONAL RADIOLOGY 2016;39 (10):1379-1391, 1537. | 0.00 | Y | 0.00000 | 20160928 | OT | GR | GR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127560102 | 12756010 | 1 | PS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | DOSE: MAXIMUM INTENDED DOSE OF??100 MG AND 150 MG OF DOXORUBICIN PER 3 ML VIAL OF TANDEM | U | U | 50718 | LIPOSOME INJECTION | |||||||
| 127560102 | 12756010 | 2 | SS | TANDEM | FERROUS ASPARTO GLYCINATEFERROUS FUMARATE | 1 | Unknown | DOSE: 33.3 MG/ML AND 50 MG/ML OF BEADS | U | 0 | MICROSPHERES |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127560102 | 12756010 | 1 | Hepatocellular carcinoma |
| 127560102 | 12756010 | 2 | Hepatocellular carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127560102 | 12756010 | OT |
| 127560102 | 12756010 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127560102 | 12756010 | Alopecia | |
| 127560102 | 12756010 | Ascites | |
| 127560102 | 12756010 | Biliary dilatation | |
| 127560102 | 12756010 | Encephalopathy | |
| 127560102 | 12756010 | Hepatic enzyme increased | |
| 127560102 | 12756010 | Hepatic failure | |
| 127560102 | 12756010 | Nausea | |
| 127560102 | 12756010 | Off label use | |
| 127560102 | 12756010 | Pain | |
| 127560102 | 12756010 | Pancreatitis | |
| 127560102 | 12756010 | Post embolisation syndrome | |
| 127560102 | 12756010 | Product use issue | |
| 127560102 | 12756010 | Pyrexia | |
| 127560102 | 12756010 | Tumour rupture | |
| 127560102 | 12756010 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |