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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125456792 | 12545679 | 2 | F | 2014 | 20160707 | 20160711 | 20160719 | EXP | DE-TEVA-674887GER | TEVA | GOERIG N, SEMRAU S, FREY B, KORN K, FLECKENSTEIN B, ?BERLA K ET AL. CLINICALLY SIGNIFICANT CMV (RE)ACTIVATION DURING OR AFTER RADIOTHERAPY/CHEMOTHERAPY OF THE BRAIN: CORRELATION WITH NEUROLOGICAL DETERIORATION AND IMPROVEMENT UPON ANTIVIRAL TREATMENT.STRAHLENTHERAPIE UND ONKOLOGIE. 2016; 1-9 | 77.00 | YR | F | Y | 0.00000 | 20160719 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125456792 | 12545679 | 1 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | 12 MILLIGRAM DAILY; TWO TIMES IN THE MORNING AND ONCE IN THE AFTERNOON | U | 0 | 4 | MG | TID | |||||||
| 125456792 | 12545679 | 2 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | 24 MILLIGRAM DAILY; | U | 0 | 8 | MG | TID | |||||||
| 125456792 | 12545679 | 3 | PS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | KOF; 100% | 78879 | 75 | MG/M**2 | |||||||||
| 125456792 | 12545679 | 4 | C | MANNITOL. | MANNITOL | 1 | 20 % ONCE DAILY FOR 3 DAYS FROM ONSET | U | 0 | ||||||||||
| 125456792 | 12545679 | 5 | C | MANNITOL. | MANNITOL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125456792 | 12545679 | 1 | Nausea |
| 125456792 | 12545679 | 2 | Headache |
| 125456792 | 12545679 | 3 | Glioblastoma multiforme |
| 125456792 | 12545679 | 4 | Nausea |
| 125456792 | 12545679 | 5 | Headache |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125456792 | 12545679 | HO |
| 125456792 | 12545679 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125456792 | 12545679 | Ataxia | |
| 125456792 | 12545679 | Cytomegalovirus infection | |
| 125456792 | 12545679 | Disorientation | |
| 125456792 | 12545679 | Drug ineffective | |
| 125456792 | 12545679 | Fatigue | |
| 125456792 | 12545679 | Speech disorder | |
| 125456792 | 12545679 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125456792 | 12545679 | 1 | 2014 | 0 | ||
| 125456792 | 12545679 | 2 | 2014 | 0 | ||
| 125456792 | 12545679 | 4 | 2014 | 0 |