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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100039042 | 10003904 | 2 | F | 20131130 | 20140616 | 20140312 | 20140630 | EXP | IT-MYLANLABS-2014S1004594 | MYLAN | 92.00 | YR | M | Y | 0.00000 | 20140629 | N | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100039042 | 10003904 | 1 | PS | ARKOLAMYL | 1 | ORAL | D | 76866 | 7.5 | MG | TABLET | QD | |||||||
| 100039042 | 10003904 | 2 | C | PHENOBARBITAL | 1 | ORAL | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 100039042 | 10003904 | 1 | Product used for unknown indication |
| 100039042 | 10003904 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 100039042 | 10003904 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 100039042 | 10003904 | Cognitive disorder | |
| 100039042 | 10003904 | Psychotic behaviour |
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 |
|---|---|---|---|---|---|---|
| 100039042 | 10003904 | 1 | 20131108 | 20131216 | 0 |