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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113300962 | 11330096 | 2 | F | 201412 | 20160805 | 20150803 | 20160817 | EXP | GB-AUROBINDO-AUR-APL-2015-06807 | AUROBINDO | 75.00 | YR | F | Y | 0.00000 | 20160817 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113300962 | 11330096 | 1 | PS | Amlodipine 10 mg | AMLODIPINE BESYLATE | 1 | Unknown | 10 MG, 1X/DAY | U | U | 78021 | 10 | MG | QD | |||||
| 113300962 | 11330096 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, WEEKLY | Y | U | 0 | 50 | MG | /wk | |||||
| 113300962 | 11330096 | 3 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 3 MG, UNK | U | U | 0 | 3 | MG | ||||||
| 113300962 | 11330096 | 4 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 3 MG, 1X/DAY | U | U | 0 | 3 | MG | QD | |||||
| 113300962 | 11330096 | 5 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | 500 MG, 4X/DAY | Y | U | 0 | 500 | MG | QID | |||||
| 113300962 | 11330096 | 6 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 113300962 | 11330096 | 7 | C | CALCICHEW D3 FORTE | CALCIUMCHOLECALCIFEROL | 1 | Unknown | UNK, 2X/DAY | U | 0 | |||||||||
| 113300962 | 11330096 | 8 | C | LISINOPRIL. | LISINOPRIL | 1 | Unknown | 20 MG, ONCE A DAY | U | 0 | 20 | MG | QD | ||||||
| 113300962 | 11330096 | 9 | C | LISINOPRIL. | LISINOPRIL | 1 | Unknown | 5 MG, ONCE A DAY | U | 0 | 5 | MG | QD | ||||||
| 113300962 | 11330096 | 10 | C | LISINOPRIL. | LISINOPRIL | 1 | Unknown | 10 MG, ONCE A DAY | U | 0 | 10 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113300962 | 11330096 | 1 | Blood pressure measurement |
| 113300962 | 11330096 | 2 | Rheumatoid arthritis |
| 113300962 | 11330096 | 3 | Product used for unknown indication |
| 113300962 | 11330096 | 5 | Product used for unknown indication |
| 113300962 | 11330096 | 7 | Osteoporosis |
| 113300962 | 11330096 | 8 | Blood pressure measurement |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113300962 | 11330096 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113300962 | 11330096 | Blepharitis | |
| 113300962 | 11330096 | Influenza | |
| 113300962 | 11330096 | Lower respiratory tract infection | |
| 113300962 | 11330096 | Neutrophil count decreased | |
| 113300962 | 11330096 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 113300962 | 11330096 | 1 | 2014 | 0 | ||
| 113300962 | 11330096 | 2 | 201305 | 0 | ||
| 113300962 | 11330096 | 3 | 1995 | 0 | ||
| 113300962 | 11330096 | 5 | 1995 | 0 | ||
| 113300962 | 11330096 | 6 | 201505 | 0 | ||
| 113300962 | 11330096 | 7 | 2014 | 0 |