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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97575104 | 9757510 | 4 | F | 2013 | 20160720 | 20131215 | 20160722 | EXP | BR-AMGEN-BRASP2013087771 | AMGEN | 48.00 | YR | A | F | Y | 103.00000 | KG | 20160722 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97575104 | 9757510 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, 1X/WEEK | H19368 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 97575104 | 9757510 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||||
| 97575104 | 9757510 | 3 | SS | MELOXICAM. | MELOXICAM | 1 | Unknown | UNK | 0 | ||||||||||
| 97575104 | 9757510 | 4 | C | CALCITRIOL. | CALCITRIOL | 1 | UNK, 2X/DAY | 0 | BID | ||||||||||
| 97575104 | 9757510 | 5 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | 200 G, 3 SPOONS 3 TIMES A DAY | 0 | 200 | G | TID | ||||||||
| 97575104 | 9757510 | 6 | C | LOSARTAN. | LOSARTAN | 1 | 50 MG, 2X/DAY | 0 | 50 | MG | BID | ||||||||
| 97575104 | 9757510 | 7 | C | ATENOLOL. | ATENOLOL | 1 | 25 MG, 2X/DAY | 0 | 25 | MG | BID | ||||||||
| 97575104 | 9757510 | 8 | C | ATENOLOL. | ATENOLOL | 1 | 25 MG, 1X/DAY | 0 | 25 | MG | QD | ||||||||
| 97575104 | 9757510 | 9 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | 25 MG, 1X/DAY | 0 | 25 | MG | QD | ||||||||
| 97575104 | 9757510 | 10 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK, 1X/DAY | 0 | QD | ||||||||||
| 97575104 | 9757510 | 11 | C | CLOPAM | 2 | 1 MG (HALF TABLET OF 2MG), AT DUSK | 0 | 1 | MG | ||||||||||
| 97575104 | 9757510 | 12 | C | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | UNK | 0 | |||||||||||
| 97575104 | 9757510 | 13 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 20 MG, 2X/DAY | 0 | 20 | MG | BID | ||||||||
| 97575104 | 9757510 | 14 | C | AMYTRIL | AMITRIPTYLINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 97575104 | 9757510 | 15 | C | AMYTRIL | AMITRIPTYLINE HYDROCHLORIDE | 1 | 50 MG (2 TABLETS OF 25MG), AT DUSK | 0 | 50 | MG | |||||||||
| 97575104 | 9757510 | 16 | C | AMYTRIL | AMITRIPTYLINE HYDROCHLORIDE | 1 | 25 MG, 1X/DAY | 0 | 25 | MG | QD | ||||||||
| 97575104 | 9757510 | 17 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 5 MG, 1X/DAY | 0 | 5 | MG | QD | ||||||||
| 97575104 | 9757510 | 18 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 5 MG, 1X/DAY | 0 | 5 | MG | QD | ||||||||
| 97575104 | 9757510 | 19 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 5 MG, 1X/DAY | 0 | 5 | MG | QD | ||||||||
| 97575104 | 9757510 | 20 | C | PURAN | LEVOTHYROXINE SODIUM | 1 | 150 MG, 1X/DAY | 0 | 150 | MG | QD | ||||||||
| 97575104 | 9757510 | 21 | C | PURAN | LEVOTHYROXINE SODIUM | 1 | UNK, 1X/DAY | 0 | QD | ||||||||||
| 97575104 | 9757510 | 22 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | 50 MG (2 TABLETS OF 25MG), AT DUSK | 0 | 50 | MG | |||||||||
| 97575104 | 9757510 | 23 | C | ATORVASTATIN | ATORVASTATIN | 1 | 40 MG (2 TABLETS OF 20 MG), AT NIGHT | 0 | 40 | MG | |||||||||
| 97575104 | 9757510 | 24 | C | ATORVASTATIN | ATORVASTATIN | 1 | 40 MG (2 TABLETS OF 20 MG), AT NIGHT | 0 | 40 | MG | |||||||||
| 97575104 | 9757510 | 25 | C | ATORVASTATIN | ATORVASTATIN | 1 | 40 MG (2 TABLETS OF 20 MG), AT NIGHT | 0 | 40 | MG | |||||||||
| 97575104 | 9757510 | 26 | C | GLIFAGE | METFORMIN HYDROCHLORIDE | 1 | 1000 MG (2 TABLETS OF 500 MG), BEFORE SLEEP | 0 | 1000 | MG | |||||||||
| 97575104 | 9757510 | 27 | C | STABIL | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | 0.25 MG, 1X/DAY | 0 | .25 | MG | QD | ||||||||
| 97575104 | 9757510 | 28 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | 25 MG, 2X/DAY | 0 | 25 | MG | BID | ||||||||
| 97575104 | 9757510 | 29 | C | INDOMETHACIN. | INDOMETHACIN | 1 | 50 MG, 1X/DAY | 0 | 50 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 97575104 | 9757510 | 1 | Ankylosing spondylitis |
| 97575104 | 9757510 | 3 | Pain |
| 97575104 | 9757510 | 4 | Hypothyroidism |
| 97575104 | 9757510 | 5 | Hypothyroidism |
| 97575104 | 9757510 | 6 | Hypertension |
| 97575104 | 9757510 | 7 | Hypertension |
| 97575104 | 9757510 | 9 | Hypertension |
| 97575104 | 9757510 | 11 | Restless legs syndrome |
| 97575104 | 9757510 | 12 | Restless legs syndrome |
| 97575104 | 9757510 | 13 | Gastritis |
| 97575104 | 9757510 | 14 | Ankylosing spondylitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 97575104 | 9757510 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 97575104 | 9757510 | Arthralgia | |
| 97575104 | 9757510 | Asthenia | |
| 97575104 | 9757510 | Blood pressure decreased | |
| 97575104 | 9757510 | Burning sensation | |
| 97575104 | 9757510 | Discomfort | |
| 97575104 | 9757510 | Hypoaesthesia | |
| 97575104 | 9757510 | Muscular weakness | |
| 97575104 | 9757510 | Pain in extremity | |
| 97575104 | 9757510 | Renal pain | |
| 97575104 | 9757510 | Syncope | |
| 97575104 | 9757510 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 97575104 | 9757510 | 1 | 201104 | 0 | ||
| 97575104 | 9757510 | 4 | 2010 | 0 | ||
| 97575104 | 9757510 | 5 | 2010 | 0 | ||
| 97575104 | 9757510 | 6 | 2010 | 0 | ||
| 97575104 | 9757510 | 7 | 2010 | 0 | ||
| 97575104 | 9757510 | 9 | 2010 | 0 | ||
| 97575104 | 9757510 | 11 | 2011 | 0 | ||
| 97575104 | 9757510 | 12 | 2011 | 0 | ||
| 97575104 | 9757510 | 13 | 2012 | 0 | ||
| 97575104 | 9757510 | 14 | 2010 | 0 |