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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126016261 | 12601626 | 1 | I | 20150404 | 20160715 | 20160728 | 20160728 | EXP | IT-DOC-162480 | IT-AUROBINDO-AUR-APL-2016-09564 | AUROBINDO | 25.76 | YR | F | Y | 0.00000 | 20160728 | MD | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126016261 | 12601626 | 1 | PS | MIRTAZAPINE. | MIRTAZAPINE | 1 | Oral | 20 DF, TOTAL | U | 76921 | 20 | DF | |||||||
| 126016261 | 12601626 | 2 | SS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 25 DF,TOTAL | U | 0 | 25 | DF | |||||||
| 126016261 | 12601626 | 3 | SS | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | Oral | 10 GTT,DROPS TOTAL | U | 0 | 10 | GTT | |||||||
| 126016261 | 12601626 | 4 | SS | SAMYR /00882301/ | ADEMETIONINE | 1 | Oral | 1 DF, TOTAL | U | 0 | 1 | DF | |||||||
| 126016261 | 12601626 | 5 | SS | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | Oral | 20 DF, TOTAL | U | 0 | 20 | DF |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126016261 | 12601626 | 1 | Depression |
| 126016261 | 12601626 | 2 | Depression |
| 126016261 | 12601626 | 3 | Depression |
| 126016261 | 12601626 | 4 | Depression |
| 126016261 | 12601626 | 5 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126016261 | 12601626 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126016261 | 12601626 | Drug abuse | |
| 126016261 | 12601626 | 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 |
|---|---|---|---|---|---|---|
| 126016261 | 12601626 | 1 | 20150404 | 20150404 | 0 | |
| 126016261 | 12601626 | 2 | 20150404 | 20150404 | 0 | |
| 126016261 | 12601626 | 3 | 20150404 | 20150404 | 0 | |
| 126016261 | 12601626 | 4 | 20150404 | 20150404 | 0 | |
| 126016261 | 12601626 | 5 | 20150404 | 20150404 | 0 |