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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125515893 | 12551589 | 3 | F | 20140502 | 20160822 | 20160713 | 20160902 | EXP | DE-SUN PHARMACEUTICAL INDUSTRIES LTD-2016RR-119986 | RANBAXY | 77.00 | YR | F | Y | 0.00000 | 20160902 | OT | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125515893 | 12551589 | 1 | PS | TEMOZOLOMIDE. | TEMOZOLOMIDE | 1 | Unknown | KOF; 100% | U | 201742 | 75 | MG/M**2 | |||||||
| 125515893 | 12551589 | 2 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 4 MG, TID | U | U | 0 | 4 | MG | Q8H | |||||
| 125515893 | 12551589 | 3 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 8 MG, TID | U | U | 0 | 8 | MG | Q8H | |||||
| 125515893 | 12551589 | 4 | SS | MANNITOL. | MANNITOL | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125515893 | 12551589 | 5 | SS | MANNITOL. | MANNITOL | 1 | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125515893 | 12551589 | 1 | Glioblastoma multiforme |
| 125515893 | 12551589 | 2 | Headache |
| 125515893 | 12551589 | 3 | Nausea |
| 125515893 | 12551589 | 4 | Nausea |
| 125515893 | 12551589 | 5 | Headache |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125515893 | 12551589 | HO |
| 125515893 | 12551589 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125515893 | 12551589 | Ataxia | |
| 125515893 | 12551589 | Cytomegalovirus infection | |
| 125515893 | 12551589 | Disorientation | |
| 125515893 | 12551589 | Drug ineffective | |
| 125515893 | 12551589 | Fatigue | |
| 125515893 | 12551589 | Speech disorder | |
| 125515893 | 12551589 | 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 |
|---|---|---|---|---|---|---|
| 125515893 | 12551589 | 3 | 2014 | 0 | ||
| 125515893 | 12551589 | 4 | 2014 | 0 |