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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121867113 | 12186711 | 3 | F | 20160829 | 20160317 | 20160907 | EXP | JP-MYLANLABS-2016M1010977 | MYLAN | TAKAHASHI N, HOSINO K, YAMADA Y, OGAWA Y, MORI T, ABE K, SHIMIZU T, ISHIHAMA H, FUJIMURA T, SIMOJIMA N, FUJINO A, SIMATA H, KURODA T.. TWO CASES OF HIGH-RISK HEPATOBLASTOMA (HB) ACHIEVING COMPLETE REMISSION BY LIVER TRANSPLANTATION (LT) WITH SIOPEL-4 PROTOCOL.. JAPANESE JOURNAL OF PEDIATRIC HEMATOLOGY/ONCOLOGY. 2015;52(4):238 | 0.00 | Y | 0.00000 | 20160905 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121867113 | 12186711 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Intravenous drip | SIOPEL4 | Y | U | 91063 | INJECTION | |||||||
| 121867113 | 12186711 | 2 | SS | CISPLATIN. | CISPLATIN | 1 | Intravenous drip | SIOPEL4 | Y | U | 0 | INJECTION | |||||||
| 121867113 | 12186711 | 3 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous drip | SIOPEL4 | Y | U | 0 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121867113 | 12186711 | 1 | Hepatoblastoma recurrent |
| 121867113 | 12186711 | 2 | Hepatoblastoma recurrent |
| 121867113 | 12186711 | 3 | Hepatoblastoma recurrent |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121867113 | 12186711 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121867113 | 12186711 | Febrile neutropenia | |
| 121867113 | 12186711 | Haematotoxicity | |
| 121867113 | 12186711 | Ototoxicity | |
| 121867113 | 12186711 | Pancreatitis acute |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |