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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125433732 | 12543373 | 2 | F | 20140502 | 20160707 | 20160711 | 20160721 | EXP | DE-ALVOGEN-2016-ALVOGEN-025804 | ALVOGEN | GOERIG N, SEMRAU S, FREY B, KORN K, FLECKENSTEIN B, UBERLA 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 | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125433732 | 12543373 | 1 | PS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | 2191718 | ||||||||||||
| 125433732 | 12543373 | 2 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | 2 TIMES IN THE MORNING AND ONCE IN THE AFTERNOON | 0 | 4 | MG | TID | ||||||||
| 125433732 | 12543373 | 3 | SS | MANNITOL 20% | MANNITOL | 1 | U | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125433732 | 12543373 | 1 | Glioblastoma multiforme |
| 125433732 | 12543373 | 2 | Nausea |
| 125433732 | 12543373 | 3 | Headache |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125433732 | 12543373 | HO |
| 125433732 | 12543373 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125433732 | 12543373 | Ataxia | |
| 125433732 | 12543373 | Cytomegalovirus infection | |
| 125433732 | 12543373 | Disorientation | |
| 125433732 | 12543373 | Fatigue | |
| 125433732 | 12543373 | Speech disorder | |
| 125433732 | 12543373 | 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 |
|---|---|---|---|---|---|---|
| 125433732 | 12543373 | 2 | 2014 | 0 | ||
| 125433732 | 12543373 | 3 | 2014 | 0 |