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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119165424 | 11916542 | 4 | F | 20150907 | 20160711 | 20160113 | 20160718 | EXP | IT2015K7214SPO | KRKA DD NOVO MESTO | 61.00 | YR | M | N | 0.00000 | 20160714 | N | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119165424 | 11916542 | 1 | PS | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 0 | |||||||||||
| 119165424 | 11916542 | 2 | SS | BISOPROLOL | BISOPROLOL | 1 | Oral | 0 | 105 | MG | 1X | ||||||||
| 119165424 | 11916542 | 3 | SS | DELTACORTENE | PREDNISONE | 1 | Oral | 0 | 10 | DF | 1X | ||||||||
| 119165424 | 11916542 | 4 | SS | VALIUM | DIAZEPAM | 1 | Oral | 0 | 20 | ML | 1X |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119165424 | 11916542 | 1 | Drug abuse |
| 119165424 | 11916542 | 2 | Drug abuse |
| 119165424 | 11916542 | 3 | Drug abuse |
| 119165424 | 11916542 | 4 | Drug abuse |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119165424 | 11916542 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119165424 | 11916542 | Drug abuse | |
| 119165424 | 11916542 | Electrocardiogram ST segment abnormal | |
| 119165424 | 11916542 | Intentional self-injury | |
| 119165424 | 11916542 | Sopor |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 119165424 | 11916542 | FGN |
| 119165424 | 11916542 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 119165424 | 11916542 | 1 | 20150907 | 20150907 | 1 | DAY |
| 119165424 | 11916542 | 2 | 20150907 | 20150907 | 1 | DAY |
| 119165424 | 11916542 | 3 | 20150907 | 20150907 | 1 | DAY |
| 119165424 | 11916542 | 4 | 20150907 | 20150907 | 1 | DAY |