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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117891242 | 11789124 | 2 | F | 20150907 | 20160712 | 20151201 | 20160720 | EXP | IT-AUROBINDO-AUR-APL-2015-10565 | AUROBINDO | 61.31 | YR | M | Y | 0.00000 | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117891242 | 11789124 | 1 | PS | Bisoprolol 2.5 mg | BISOPROLOL | 1 | Oral | 2.5 MG DOSAGE FORM X42 | U | 77910 | 42 | DF | |||||||
| 117891242 | 11789124 | 2 | SS | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | U | 0 | ||||||||||
| 117891242 | 11789124 | 3 | SS | DELTACORTENE | PREDNISONE | 1 | Oral | 10 DF TOTAL | U | 0 | 10 | DF | TABLET | ||||||
| 117891242 | 11789124 | 4 | SS | VALIUM | DIAZEPAM | 1 | Oral | 20 ML TOTAL | U | 0 | 20 | ML | ORAL DROPS, SOLUTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117891242 | 11789124 | 1 | Product used for unknown indication |
| 117891242 | 11789124 | 2 | Product used for unknown indication |
| 117891242 | 11789124 | 3 | Product used for unknown indication |
| 117891242 | 11789124 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117891242 | 11789124 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117891242 | 11789124 | Drug abuse | |
| 117891242 | 11789124 | Electrocardiogram ST segment abnormal | |
| 117891242 | 11789124 | Intentional self-injury | |
| 117891242 | 11789124 | Sopor |
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 |
|---|---|---|---|---|---|---|
| 117891242 | 11789124 | 1 | 20150907 | 20150907 | 0 | |
| 117891242 | 11789124 | 2 | 20150907 | 20150907 | 0 | |
| 117891242 | 11789124 | 3 | 20150907 | 20150907 | 0 | |
| 117891242 | 11789124 | 4 | 20150907 | 20150907 | 0 |