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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125689432 | 12568943 | 2 | F | 2014 | 20160714 | 20160719 | 20160727 | EXP | DE-MLMSERVICE-20160630-0322609-2 | DE-ACCORD-042414 | ACCORD | 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. | 59.00 | YR | M | Y | 0.00000 | 20160727 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125689432 | 12568943 | 1 | PS | ETOPOSIDE. | ETOPOSIDE | 1 | KOF; 100%; Q29; Q57 | U | 74513 | 270 | MG/M**2 | ||||||||
| 125689432 | 12568943 | 2 | SS | CISPLATIN. | CISPLATIN | 1 | KOF; 100%; Q29; Q57 | U | 206774 | 90 | MG/M**2 | ||||||||
| 125689432 | 12568943 | 3 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | U | 0 | 4 | MG | TID | ||||||||
| 125689432 | 12568943 | 4 | SS | MANNITOL. | MANNITOL | 1 | STRENGTH: 20 % | U | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125689432 | 12568943 | 1 | Nasal sinus cancer |
| 125689432 | 12568943 | 2 | Nasal sinus cancer |
| 125689432 | 12568943 | 3 | Disorientation |
| 125689432 | 12568943 | 4 | Disorientation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125689432 | 12568943 | OT |
| 125689432 | 12568943 | HO |
| 125689432 | 12568943 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125689432 | 12568943 | Agitation | |
| 125689432 | 12568943 | Ataxia | |
| 125689432 | 12568943 | Cytomegalovirus infection | |
| 125689432 | 12568943 | Disorientation | |
| 125689432 | 12568943 | Drug ineffective | |
| 125689432 | 12568943 | Incontinence | |
| 125689432 | 12568943 | Off label use | |
| 125689432 | 12568943 | 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 |
|---|---|---|---|---|---|---|
| 125689432 | 12568943 | 3 | 2014 | 0 | ||
| 125689432 | 12568943 | 4 | 2014 | 0 |