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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124711892 | 12471189 | 2 | F | 20160714 | 20160616 | 20160728 | EXP | GB-MHRA-MIDB-19630C62-C8A4-4627-B204-DE4C1FCF0079 | GB-LUPIN PHARMACEUTICALS INC.-E2B_00005579 | LUPIN | 14.00 | YR | F | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124711892 | 12471189 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | U | UNKNOWN | 77670 | |||||||||
| 124711892 | 12471189 | 2 | SS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | U | UNKNOWN | 77670 | 150 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124711892 | 12471189 | 1 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124711892 | 12471189 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124711892 | 12471189 | Abnormal weight gain | |
| 124711892 | 12471189 | Amenorrhoea | |
| 124711892 | 12471189 | Asthenia | |
| 124711892 | 12471189 | Blindness | |
| 124711892 | 12471189 | Dizziness | |
| 124711892 | 12471189 | Neurological symptom | |
| 124711892 | 12471189 | Sensory loss | |
| 124711892 | 12471189 | Strabismus |
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 |
|---|---|---|---|---|---|---|
| 124711892 | 12471189 | 2 | 201512 | 0 |