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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116654202 | 11665420 | 2 | F | 20150924 | 20160921 | 20151027 | 20160930 | EXP | JP-AMGEN-JPNCT2015112771 | AMGEN | 87.00 | YR | E | M | Y | 59.00000 | KG | 20160930 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116654202 | 11665420 | 1 | PS | darbepoetin alfa | DARBEPOETIN ALFA | 1 | Unknown | 60 MUG, UNK | 103951 | 60 | UG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 116654202 | 11665420 | 2 | SS | darbepoetin alfa | DARBEPOETIN ALFA | 1 | Unknown | 90 MUG, UNK | 103951 | 90 | UG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 116654202 | 11665420 | 3 | SS | darbepoetin alfa | DARBEPOETIN ALFA | 1 | Unknown | 120 MUG, Q4WK | 103951 | 120 | UG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 116654202 | 11665420 | 4 | SS | darbepoetin alfa | DARBEPOETIN ALFA | 1 | Unknown | 180 MUG, Q4WK | 103951 | 180 | UG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 116654202 | 11665420 | 5 | SS | MICARDIS | TELMISARTAN | 1 | Oral | 40 MG, QD | 0 | 40 | MG | TABLET | QD | ||||||
| 116654202 | 11665420 | 6 | SS | FLIVAS | NAFTOPIDIL | 1 | Oral | 25 MG, QD | 0 | 25 | MG | TABLET | QD | ||||||
| 116654202 | 11665420 | 7 | SS | FLIVAS | NAFTOPIDIL | 1 | Oral | 50 MG, QD | 0 | 50 | MG | TABLET | QD | ||||||
| 116654202 | 11665420 | 8 | SS | OPALMON | LIMAPROST | 1 | Oral | 5 MUG, TID | 0 | 5 | UG | TABLET | TID | ||||||
| 116654202 | 11665420 | 9 | SS | METHYCOBAL | METHYLCOBALAMIN | 1 | Oral | 500 MUG, TID | 0 | 500 | UG | TABLET | TID | ||||||
| 116654202 | 11665420 | 10 | SS | ALFAROL | ALFACALCIDOL | 1 | Oral | 0.25 MUG, QD | 0 | .25 | UG | CAPSULE | QD | ||||||
| 116654202 | 11665420 | 11 | SS | CELECOX | CELECOXIB | 1 | Oral | 100 MG, BID | 0 | 100 | MG | TABLET | BID | ||||||
| 116654202 | 11665420 | 12 | SS | CELECOX | CELECOXIB | 1 | Oral | 100 MG, BID | 0 | 100 | MG | TABLET | BID | ||||||
| 116654202 | 11665420 | 13 | SS | LYRICA | PREGABALIN | 1 | Oral | 100 MG, QD | 0 | 100 | MG | CAPSULE | QD | ||||||
| 116654202 | 11665420 | 14 | SS | LYRICA | PREGABALIN | 1 | 0 | CAPSULE | |||||||||||
| 116654202 | 11665420 | 15 | SS | LASIX | FUROSEMIDE | 1 | Oral | 10 MG, QD | 0 | 10 | MG | QD | |||||||
| 116654202 | 11665420 | 16 | SS | ZYLORIC | ALLOPURINOL | 1 | Oral | 100 MG, BID | 0 | 100 | MG | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116654202 | 11665420 | 1 | Chronic kidney disease |
| 116654202 | 11665420 | 5 | Hypertension |
| 116654202 | 11665420 | 6 | Neurogenic bladder |
| 116654202 | 11665420 | 7 | Benign prostatic hyperplasia |
| 116654202 | 11665420 | 8 | Lumbar spinal stenosis |
| 116654202 | 11665420 | 9 | Neuropathy peripheral |
| 116654202 | 11665420 | 10 | Hyperparathyroidism secondary |
| 116654202 | 11665420 | 11 | Pain |
| 116654202 | 11665420 | 13 | Neuropathy peripheral |
| 116654202 | 11665420 | 14 | Lumbar spinal stenosis |
| 116654202 | 11665420 | 15 | Oedema due to renal disease |
| 116654202 | 11665420 | 16 | Chronic kidney disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116654202 | 11665420 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116654202 | 11665420 | Dehydration | |
| 116654202 | 11665420 | Disuse syndrome | |
| 116654202 | 11665420 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 116654202 | 11665420 | 1 | 20150729 | 0 | ||
| 116654202 | 11665420 | 2 | 20150826 | 0 | ||
| 116654202 | 11665420 | 3 | 20150924 | 0 | ||
| 116654202 | 11665420 | 4 | 20150924 | 0 | ||
| 116654202 | 11665420 | 5 | 20100414 | 0 | ||
| 116654202 | 11665420 | 6 | 20130313 | 0 | ||
| 116654202 | 11665420 | 7 | 20130508 | 0 | ||
| 116654202 | 11665420 | 8 | 20140702 | 0 | ||
| 116654202 | 11665420 | 9 | 20140702 | 0 | ||
| 116654202 | 11665420 | 10 | 20140702 | 0 | ||
| 116654202 | 11665420 | 11 | 20150615 | 0 | ||
| 116654202 | 11665420 | 12 | 20130702 | 0 | ||
| 116654202 | 11665420 | 13 | 20131204 | 0 | ||
| 116654202 | 11665420 | 15 | 20150826 | 0 | ||
| 116654202 | 11665420 | 16 | 20151118 | 0 |