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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125622732 | 12562273 | 2 | F | 20160712 | 20160715 | 20160727 | EXP | IT-009507513-1607ITA006154 | MERCK | 0.00 | Y | 0.00000 | 20160727 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125622732 | 12562273 | 1 | PS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 75 MG/M2, UNK | U | 21029 | 75 | MG/M**2 | CAPSULE | ||||||
| 125622732 | 12562273 | 2 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | 200-250 MG/M2 FOR 5/28 DAYS FOR ABOUT 6-8 CYCLES | U | 21029 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125622732 | 12562273 | 1 | Malignant glioma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125622732 | 12562273 | OT |
| 125622732 | 12562273 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125622732 | 12562273 | Anaemia | |
| 125622732 | 12562273 | Deep vein thrombosis | |
| 125622732 | 12562273 | Fatigue | |
| 125622732 | 12562273 | Haematotoxicity | |
| 125622732 | 12562273 | Neutropenia | |
| 125622732 | 12562273 | Pneumonia | |
| 125622732 | 12562273 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |