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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127298161 | 12729816 | 1 | I | 2015 | 20160831 | 20160909 | 20160909 | EXP | DE-LUNDBECK-DKLU2019122 | LUNDBECK | EFFERTH T, SCHOTTLER U, KRISHNA S, SCHMIEDEK P, WENZ F, GIORDANO F. HEPATOTOXICITY BY COMBINATION TREATMENT OF TEMOZOLOMIDE, ARTESUNATE AND CHINESE HERBS IN A GLIOBLASTOMA MULTIFORME PATIENT: CASE REPORT REVIEW OF THE LITERATURE. ARCH TOXICOL. 2016 AUG 12;12:1-14. | 65.00 | YR | F | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127298161 | 12729816 | 1 | PS | Clobazam | CLOBAZAM | 1 | Oral | U | 202067 | 5 | MG | ||||||||
| 127298161 | 12729816 | 2 | SS | ONDANSETRON | ONDANSETRON | 1 | Unknown | U | 0 | 8 | MG | QD | |||||||
| 127298161 | 12729816 | 3 | SS | LORAZEPAM. | LORAZEPAM | 1 | Oral | U | 0 | 1 | MG | ||||||||
| 127298161 | 12729816 | 4 | SS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Oral | U | 0 | 50 | MG/M**2 | QD | |||||||
| 127298161 | 12729816 | 5 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Unknown | U | 0 | ||||||||||
| 127298161 | 12729816 | 6 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | U | 0 | 1000 | MG | QD | |||||||
| 127298161 | 12729816 | 7 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | U | 0 | 2750 | MG | QD | |||||||
| 127298161 | 12729816 | 8 | SS | ARTESUNATE | ARTESUNATE | 1 | Unknown | Y | 0 | 200 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127298161 | 12729816 | 1 | Epilepsy |
| 127298161 | 12729816 | 2 | Prophylaxis |
| 127298161 | 12729816 | 3 | Epilepsy |
| 127298161 | 12729816 | 4 | Glioblastoma multiforme |
| 127298161 | 12729816 | 5 | Epilepsy |
| 127298161 | 12729816 | 6 | Epilepsy |
| 127298161 | 12729816 | 8 | Malaria prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127298161 | 12729816 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127298161 | 12729816 | Drug interaction | |
| 127298161 | 12729816 | Hepatotoxicity |
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 |
|---|---|---|---|---|---|---|
| 127298161 | 12729816 | 4 | 2014 | 0 | ||
| 127298161 | 12729816 | 8 | 20150920 | 20151020 | 0 |