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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126173471 | 12617347 | 1 | I | 20151222 | 20160720 | 20160803 | 20160803 | EXP | GB-AUROBINDO-AUR-APL-2016-09688 | AUROBINDO | 0.00 | Y | 0.00000 | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126173471 | 12617347 | 1 | PS | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 1 DF, ONCE A DAY, AT NIGHT. | 563.042 | DF | U | 77691 | 1 | DF | QD | ||||
| 126173471 | 12617347 | 2 | SS | Tamoxifen | TAMOXIFEN | 1 | Oral | 1 DF, ONCE A DAY | 1 | DF | Y | U | 0 | 1 | DF | QD | |||
| 126173471 | 12617347 | 3 | SS | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 1 DF, ONCE ADAY, IN THE MORNING. | 740 | DF | U | 0 | 1 | DF | QD | ||||
| 126173471 | 12617347 | 4 | SS | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 125 ?G, ONCE A DAY | 92500 | UG | U | 0 | 125 | UG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126173471 | 12617347 | 1 | Hypercholesterolaemia |
| 126173471 | 12617347 | 2 | Neoplasm prophylaxis |
| 126173471 | 12617347 | 3 | Hiatus hernia |
| 126173471 | 12617347 | 4 | Hypothyroidism |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126173471 | 12617347 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126173471 | 12617347 | Anal incontinence | |
| 126173471 | 12617347 | Balance disorder | |
| 126173471 | 12617347 | Cold sweat | |
| 126173471 | 12617347 | Deafness | |
| 126173471 | 12617347 | Feeling cold | |
| 126173471 | 12617347 | Headache | |
| 126173471 | 12617347 | Hyperhidrosis | |
| 126173471 | 12617347 | Photosensitivity reaction | |
| 126173471 | 12617347 | 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 |
|---|---|---|---|---|---|---|
| 126173471 | 12617347 | 1 | 20140607 | 0 | ||
| 126173471 | 12617347 | 2 | 20151221 | 20160331 | 0 | |
| 126173471 | 12617347 | 3 | 20131212 | 0 | ||
| 126173471 | 12617347 | 4 | 20131212 | 0 |