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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125368193 | 12536819 | 3 | F | 2014 | 20160830 | 20160707 | 20160905 | EXP | DE-009507513-1607DEU002503 | MERCK | 77.00 | YR | F | Y | 0.00000 | 20160905 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125368193 | 12536819 | 1 | PS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | KOF; 100% | 21029 | 75 | MG/M**2 | CAPSULE | QD | |||||||
| 125368193 | 12536819 | 2 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | 2 TIMES IN THE MORNING AND ONCE IN THE AFTERNOON | 0 | 4 | MG | TID | ||||||||
| 125368193 | 12536819 | 3 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | 8 MG, TID | 0 | 8 | MG | TID | ||||||||
| 125368193 | 12536819 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | 2 TIMES IN THE MORNING AND ONCE IN THE AFTERNOON | 0 | 4 | MG | TID | ||||||||
| 125368193 | 12536819 | 5 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | 8 MG, TID | 0 | 8 | MG | TID | ||||||||
| 125368193 | 12536819 | 6 | SS | MANNITOL. | MANNITOL | 1 | QD | U | 0 | QD | |||||||||
| 125368193 | 12536819 | 7 | SS | MANNITOL. | MANNITOL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125368193 | 12536819 | 1 | Glioblastoma multiforme |
| 125368193 | 12536819 | 2 | Nausea |
| 125368193 | 12536819 | 3 | Headache |
| 125368193 | 12536819 | 6 | Nausea |
| 125368193 | 12536819 | 7 | Headache |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125368193 | 12536819 | HO |
| 125368193 | 12536819 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125368193 | 12536819 | Ataxia | |
| 125368193 | 12536819 | Cytomegalovirus infection | |
| 125368193 | 12536819 | Disorientation | |
| 125368193 | 12536819 | Drug ineffective | |
| 125368193 | 12536819 | Fatigue | |
| 125368193 | 12536819 | Speech disorder | |
| 125368193 | 12536819 | 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 |
|---|---|---|---|---|---|---|
| 125368193 | 12536819 | 2 | 2014 | 0 | ||
| 125368193 | 12536819 | 3 | 2014 | 0 | ||
| 125368193 | 12536819 | 4 | 2014 | 0 | ||
| 125368193 | 12536819 | 5 | 2014 | 0 | ||
| 125368193 | 12536819 | 6 | 2014 | 0 |