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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126695971 | 12669597 | 1 | I | 201605 | 20160812 | 20160819 | 20160819 | EXP | US-AMGEN-USASP2016106111 | AMGEN | 14.00 | YR | T | F | Y | 0.00000 | 20160819 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126695971 | 12669597 | 1 | PS | EPOGEN | ERYTHROPOIETIN | 1 | Unknown | UNK | N | 103234 | SOLUTION FOR INJECTION | ||||||||
| 126695971 | 12669597 | 2 | SS | ARANESP | DARBEPOETIN ALFA | 1 | Unknown | UNK, QWK | 0 | SOLUTION FOR INJECTION | /wk | ||||||||
| 126695971 | 12669597 | 3 | SS | ARANESP | DARBEPOETIN ALFA | 1 | Unknown | 25 MUG, QWK | 0 | 25 | UG | SOLUTION FOR INJECTION | /wk | ||||||
| 126695971 | 12669597 | 4 | SS | ARANESP | DARBEPOETIN ALFA | 1 | Unknown | 40 MUG, UNK | 0 | 40 | UG | SOLUTION FOR INJECTION | |||||||
| 126695971 | 12669597 | 5 | SS | SENSIPAR | CINACALCET HYDROCHLORIDE | 1 | Oral | 15 MG, QD | 0 | 15 | MG | TABLET | QD | ||||||
| 126695971 | 12669597 | 6 | SS | SENSIPAR | CINACALCET HYDROCHLORIDE | 1 | Oral | 30 MG, QD | 0 | 30 | MG | TABLET | QD | ||||||
| 126695971 | 12669597 | 7 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | UNK UNK, QD | 0 | QD | |||||||||
| 126695971 | 12669597 | 8 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | UNK UNK, QD | 0 | QD | |||||||||
| 126695971 | 12669597 | 9 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | UNK UNK, QD | 0 | QD | |||||||||
| 126695971 | 12669597 | 10 | C | CALCITRIOL. | CALCITRIOL | 1 | Unknown | UNK UNK, QD | 0 | QD | |||||||||
| 126695971 | 12669597 | 11 | C | RENVELA | SEVELAMER CARBONATE | 1 | Unknown | UNK | 0 | ||||||||||
| 126695971 | 12669597 | 12 | C | PHOSPHORUS | PHOSPHORUS | 1 | Oral | 0 | |||||||||||
| 126695971 | 12669597 | 13 | C | SODIUM BICARB.PED | 2 | Unknown | 0 | ||||||||||||
| 126695971 | 12669597 | 14 | C | IRON | IRON | 1 | Unknown | 325 MG, BID | 0 | 325 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126695971 | 12669597 | 1 | Nephrogenic anaemia |
| 126695971 | 12669597 | 2 | Nephrogenic anaemia |
| 126695971 | 12669597 | 5 | Hyperparathyroidism secondary |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126695971 | 12669597 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126695971 | 12669597 | Blood count abnormal | |
| 126695971 | 12669597 | Blood pressure abnormal | |
| 126695971 | 12669597 | Drug ineffective | |
| 126695971 | 12669597 | Haemoglobin abnormal | |
| 126695971 | 12669597 | Hyperparathyroidism | |
| 126695971 | 12669597 | Influenza like illness | |
| 126695971 | 12669597 | Lethargy | |
| 126695971 | 12669597 | Off label use | |
| 126695971 | 12669597 | Peritoneal dialysis |
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 |
|---|---|---|---|---|---|---|
| 126695971 | 12669597 | 6 | 201605 | 0 | ||
| 126695971 | 12669597 | 11 | 201606 | 0 |