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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125422042 | 12542204 | 2 | F | 2014 | 20160707 | 20160708 | 20160715 | EXP | DE-BAUSCH-BL-2016-016118 | BAUSCH AND LOMB | GOERIG N, SEMRAU S, FREY B, KORN K, FLECKENSTEIN K, UBERLA K. 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 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125422042 | 12542204 | 1 | PS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | U | 40700 | 4 | MG | TID | |||||||
| 125422042 | 12542204 | 2 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | U | 40700 | |||||||||||
| 125422042 | 12542204 | 3 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | U | 40700 | |||||||||||
| 125422042 | 12542204 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | U | 40700 | |||||||||||
| 125422042 | 12542204 | 5 | SS | MANNITOL. | MANNITOL | 1 | Unknown | U | 0 | QD | |||||||||
| 125422042 | 12542204 | 6 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | KOF; 100 PERCENT; Q29; Q57 | U | 0 | 90 | MG/M**2 | |||||||
| 125422042 | 12542204 | 7 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | KOF; 100 PERCENT; Q29; Q57 | U | 0 | 270 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125422042 | 12542204 | 1 | Agitation |
| 125422042 | 12542204 | 2 | Ataxia |
| 125422042 | 12542204 | 3 | Disorientation |
| 125422042 | 12542204 | 4 | Incontinence |
| 125422042 | 12542204 | 5 | Product used for unknown indication |
| 125422042 | 12542204 | 6 | Nasal sinus cancer |
| 125422042 | 12542204 | 7 | Nasal sinus cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125422042 | 12542204 | OT |
| 125422042 | 12542204 | HO |
| 125422042 | 12542204 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125422042 | 12542204 | Agitation | |
| 125422042 | 12542204 | Ataxia | |
| 125422042 | 12542204 | Cytomegalovirus infection | |
| 125422042 | 12542204 | Disorientation | |
| 125422042 | 12542204 | Drug ineffective | |
| 125422042 | 12542204 | Incontinence | |
| 125422042 | 12542204 | 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 |
|---|---|---|---|---|---|---|
| 125422042 | 12542204 | 1 | 2014 | 0 | ||
| 125422042 | 12542204 | 5 | 2014 | 0 |