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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124953153 | 12495315 | 3 | F | 20160729 | 20160624 | 20160808 | EXP | IT-TEVA-670168ACC | TEVA | MANDEL V. CONGENITAL GLIOBLASTOMA MULTIFORME AND ERUPTIVE DISSEMINATED SPITZ NEVI.. ITALIAN JOURNAL OF PEDIATRICS. 2016 JAN 01;. | 1.00 | YR | M | Y | 0.00000 | 20160808 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124953153 | 12495315 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | 50 MG/KG DAILY; | U | 77269 | 50 | MG/KG | QD | |||||||
| 124953153 | 12495315 | 2 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | 25 MG/KG, UNK | U | 77269 | 25 | MG/KG | |||||||
| 124953153 | 12495315 | 3 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 80 MG/KG, UNK | U | 74284 | 80 | MG/KG | |||||||
| 124953153 | 12495315 | 4 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 50 UNK, UNK | U | 74284 | |||||||||
| 124953153 | 12495315 | 5 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 135 MG/KG, UNK | U | 0 | 135 | MG/KG | |||||||
| 124953153 | 12495315 | 6 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | 0.04 MG/KG, UNK | U | 75493 | .04 | MG/KG | |||||||
| 124953153 | 12495315 | 7 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 250 MG/KG, UNK | U | 81099 | 250 | MG/KG | |||||||
| 124953153 | 12495315 | 8 | SS | MELPHALAN | MELPHALAN | 1 | 4 MG/KG DAILY; | U | 0 | 4 | MG/KG | QD | |||||||
| 124953153 | 12495315 | 9 | SS | THIOTEPA. | THIOTEPA | 1 | 10 MG/KG DAILY; | U | 0 | 10 | MG/KG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124953153 | 12495315 | 1 | Glioblastoma multiforme |
| 124953153 | 12495315 | 3 | Product used for unknown indication |
| 124953153 | 12495315 | 5 | Product used for unknown indication |
| 124953153 | 12495315 | 6 | Product used for unknown indication |
| 124953153 | 12495315 | 7 | Product used for unknown indication |
| 124953153 | 12495315 | 8 | Glioblastoma multiforme |
| 124953153 | 12495315 | 9 | Glioblastoma multiforme |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124953153 | 12495315 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124953153 | 12495315 | Juvenile melanoma benign | |
| 124953153 | 12495315 | Product use issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |