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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126175623 | 12617562 | 3 | F | 20151222 | 20160916 | 20160803 | 20160930 | EXP | GB-MHRA-EYC 00142519 | GB-LUPIN PHARMACEUTICALS INC.-E2B_00005903 | LUPIN | 70.00 | YR | F | Y | 0.00000 | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126175623 | 12617562 | 1 | SS | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | IN THE MORNING | 740 | DF | D | U | UNKNOWN | 0 | 1 | DF | QD | ||
| 126175623 | 12617562 | 2 | SS | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 92500 | UG | D | U | UNKNOWN | 0 | 125 | UG | QD | |||
| 126175623 | 12617562 | 3 | PS | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | AT NIGHT | 563.041666 | DF | D | U | UNKNOWN | 78103 | 1 | DF | QD | ||
| 126175623 | 12617562 | 4 | SS | Tamoxifen | TAMOXIFEN | 1 | Oral | 1 | DF | Y | U | UNKNOWN | 0 | 1 | DF | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126175623 | 12617562 | 1 | Hiatus hernia |
| 126175623 | 12617562 | 2 | Hypothyroidism |
| 126175623 | 12617562 | 3 | Hypercholesterolaemia |
| 126175623 | 12617562 | 4 | Neoplasm prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126175623 | 12617562 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126175623 | 12617562 | Anal incontinence | |
| 126175623 | 12617562 | Balance disorder | |
| 126175623 | 12617562 | Cold sweat | |
| 126175623 | 12617562 | Deafness | |
| 126175623 | 12617562 | Feeling cold | |
| 126175623 | 12617562 | Headache | |
| 126175623 | 12617562 | Hyperhidrosis | |
| 126175623 | 12617562 | Photosensitivity reaction | |
| 126175623 | 12617562 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126175623 | 12617562 | 1 | 20131212 | 0 | ||
| 126175623 | 12617562 | 2 | 20131212 | 0 | ||
| 126175623 | 12617562 | 3 | 20140607 | 0 | ||
| 126175623 | 12617562 | 4 | 20151221 | 20160331 | 0 |