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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125843621 | 12584362 | 1 | I | 20151202 | 20160722 | 20160722 | EXP | IT-MYLANLABS-2015M1044610 | MYLAN | LOMBARDI G, PAMBUKU A, BELLU L, DELLA PUPPA A, RUMANO L, GARDIMAN MP, ET AL. CISPLATIN AND TEMOZOLOMIDE COMBINATION IN THE TREATMENT OF SUPRATENTORIAL ANAPLASTIC EPENDYMOMA. CHEMOTHERAPY 2014; 59(3):176-180. | 0.00 | Y | 0.00000 | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125843621 | 12584362 | 1 | PS | CISPLATIN. | CISPLATIN | 1 | Intravenous drip | 60 MIN INFUSION ON DAY 1 AT DOSE OF 75 MG/M2 WITH HYDRATION; TREATMENT REPEATED EVERY 21 DAYS | U | 91062 | INJECTION | ||||||||
| 125843621 | 12584362 | 2 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 5 CONSECUTIVE DAYS AT 150MG/M2 SINGLE DOSE; TREATMENT REPEATED EVERY 21 DAYS | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125843621 | 12584362 | 1 | Ependymoma malignant |
| 125843621 | 12584362 | 2 | Ependymoma malignant |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125843621 | 12584362 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125843621 | 12584362 | Alopecia | |
| 125843621 | 12584362 | Anaemia | |
| 125843621 | 12584362 | Fatigue | |
| 125843621 | 12584362 | Nausea | |
| 125843621 | 12584362 | Nephropathy toxic | |
| 125843621 | 12584362 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |