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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120520802 | 12052080 | 2 | F | 20150709 | 20160803 | 20160209 | 20160810 | EXP | JP-ASTELLAS-2016JP001663 | ASTELLAS | 79.61 | YR | F | Y | 0.00000 | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120520802 | 12052080 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 487 | MG | 50708 | 1 | MG | CAPSULE | BID | |||||
| 120520802 | 12052080 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 487 | MG | 50708 | 1.5 | MG | CAPSULE | BID | |||||
| 120520802 | 12052080 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 487 | MG | Y | 50708 | 2 | MG | CAPSULE | BID | ||||
| 120520802 | 12052080 | 4 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 40 | MG | U | 0 | 5 | MG | PER ORAL NOS | QD | ||||
| 120520802 | 12052080 | 5 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 40 | MG | U | 0 | 10 | MG | PER ORAL NOS | QD | ||||
| 120520802 | 12052080 | 6 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 40 | MG | U | 0 | 10 | MG | PER ORAL NOS | QD | ||||
| 120520802 | 12052080 | 7 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 6000 | MG | U | 0 | 1000 | MG | INJECTION | QD | ||||
| 120520802 | 12052080 | 8 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 6000 | MG | U | 0 | 1000 | MG | INJECTION | QD | ||||
| 120520802 | 12052080 | 9 | C | PARIET | RABEPRAZOLE SODIUM | 1 | Oral | U | 0 | 10 | MG | PER ORAL NOS | QD | ||||||
| 120520802 | 12052080 | 10 | C | BACTRAMIN | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 80/400MG, ONCE DAILY | U | 0 | PER ORAL NOS | QD | |||||||
| 120520802 | 12052080 | 11 | C | GLAKAY | MENATETRENONE | 1 | Oral | U | 0 | 45 | MG | PER ORAL NOS | QD | ||||||
| 120520802 | 12052080 | 12 | C | DORNER | BERAPROST SODIUM | 1 | Oral | U | 0 | 60 | UG | PER ORAL NOS | QD | ||||||
| 120520802 | 12052080 | 13 | C | DORNER | BERAPROST SODIUM | 1 | Oral | U | 0 | 60 | UG | PER ORAL NOS | QD | ||||||
| 120520802 | 12052080 | 14 | C | RESPLEN | EPRAZINONE | 1 | Oral | U | 0 | 60 | MG | PER ORAL NOS | QD | ||||||
| 120520802 | 12052080 | 15 | C | KARY UNI /00528801/ | PIRENOXINE | 1 | Ophthalmic | UNK UNK, UNKNOWN FREQ. | U | 0 | EYE DROPS | ||||||||
| 120520802 | 12052080 | 16 | C | EDIROL | ELDECALCITOL | 1 | Oral | 0.75 ?G, ONCE DAILY | U | 0 | .75 | UG | PER ORAL NOS | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120520802 | 12052080 | 1 | Interstitial lung disease |
| 120520802 | 12052080 | 2 | Polymyositis |
| 120520802 | 12052080 | 4 | Product used for unknown indication |
| 120520802 | 12052080 | 7 | Interstitial lung disease |
| 120520802 | 12052080 | 8 | Polymyositis |
| 120520802 | 12052080 | 9 | Prophylaxis |
| 120520802 | 12052080 | 10 | Prophylaxis |
| 120520802 | 12052080 | 11 | Product used for unknown indication |
| 120520802 | 12052080 | 12 | Product used for unknown indication |
| 120520802 | 12052080 | 14 | Interstitial lung disease |
| 120520802 | 12052080 | 15 | Product used for unknown indication |
| 120520802 | 12052080 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120520802 | 12052080 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120520802 | 12052080 | Blood creatinine increased | |
| 120520802 | 12052080 | Large intestine polyp |
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 |
|---|---|---|---|---|---|---|
| 120520802 | 12052080 | 1 | 20150311 | 20150317 | 0 | |
| 120520802 | 12052080 | 2 | 20150318 | 20150511 | 0 | |
| 120520802 | 12052080 | 3 | 20150512 | 20150727 | 0 | |
| 120520802 | 12052080 | 4 | 20150310 | 0 | ||
| 120520802 | 12052080 | 5 | 20150314 | 20150317 | 0 | |
| 120520802 | 12052080 | 6 | 20150321 | 0 | ||
| 120520802 | 12052080 | 7 | 20150311 | 20150313 | 0 | |
| 120520802 | 12052080 | 8 | 20150318 | 20150320 | 0 | |
| 120520802 | 12052080 | 12 | 20150701 | 0 | ||
| 120520802 | 12052080 | 13 | 20150711 | 0 | ||
| 120520802 | 12052080 | 16 | 20150318 | 0 |