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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127433141 | 12743314 | 1 | I | 20160822 | 20160905 | 20160914 | 20160914 | EXP | GB-MHRA-EYC 00144579 | GB-TEVA-691335ACC | TEVA | 38.00 | YR | M | Y | 105.00000 | KG | 20160914 | PH | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127433141 | 12743314 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 50 MILLIGRAM DAILY; | 50 | MG | U | 76465 | 50 | MG | QD | ||||
| 127433141 | 12743314 | 2 | SS | ZOPICLONE | ZOPICLONE | 1 | Oral | 3.75 MILLIGRAM DAILY; AT NIGHT. | 3.75 | MG | U | 0 | 3.75 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127433141 | 12743314 | 1 | Anxiety |
| 127433141 | 12743314 | 2 | Sleep disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127433141 | 12743314 | OT |
| 127433141 | 12743314 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127433141 | 12743314 | Hemianopia |
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 |
|---|---|---|---|---|---|---|
| 127433141 | 12743314 | 1 | 20160822 | 20160823 | 0 | |
| 127433141 | 12743314 | 2 | 20160822 | 20160823 | 0 |