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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127278291 | 12727829 | 1 | I | 20131116 | 20131119 | 20160909 | 20160909 | EXP | FR-ASTELLAS-2013EU010459 | ASTELLAS | 40.47 | YR | M | Y | 0.00000 | 20160909 | CN | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127278291 | 12727829 | 1 | PS | TACROLIMUS. | TACROLIMUS | 1 | Oral | UNK UNK, UNKNOWN FREQ. | Y | 204096 | MODIFIED-RELEASE CAPSULE, HARD | ||||||||
| 127278291 | 12727829 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Intravenous (not otherwise specified) | UNK, UNKNOWN FREQ. | U | 204096 | MODIFIED-RELEASE CAPSULE, HARD | ||||||||
| 127278291 | 12727829 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 3 MG, PER DAY | U | 204096 | 3 | MG | MODIFIED-RELEASE CAPSULE, HARD | QD | |||||
| 127278291 | 12727829 | 4 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Oral | UNK UNK, UNKNOWN FREQ. | Y | 0 | FORMULATION UNKNOWN | ||||||||
| 127278291 | 12727829 | 5 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Intravenous (not otherwise specified) | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127278291 | 12727829 | 6 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127278291 | 12727829 | 7 | SS | CORTANCYL | PREDNISONE | 1 | Unknown | 0 | 10 | MG | FORMULATION UNKNOWN | QD | |||||||
| 127278291 | 12727829 | 8 | C | NEVIBOLOL DCI | NEBIVOLOL | 1 | Unknown | U | 0 | 2.5 | MG | FORMULATION UNKNOWN | |||||||
| 127278291 | 12727829 | 9 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | U | 0 | 40 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127278291 | 12727829 | 10 | C | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | Unknown | U | 0 | 20 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127278291 | 12727829 | 11 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | U | 0 | 500 | MG | FORMULATION UNKNOWN | BID | ||||||
| 127278291 | 12727829 | 12 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Unknown | 0.2 MG, TWICE DAILY | U | 0 | .2 | MG | FORMULATION UNKNOWN | BID | |||||
| 127278291 | 12727829 | 13 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | U | 0 | 20 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127278291 | 12727829 | 14 | C | ZOPICLONE | ZOPICLONE | 1 | Unknown | U | 0 | 7.5 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127278291 | 12727829 | 15 | C | LINEZOLID. | LINEZOLID | 1 | Unknown | U | 0 | 600 | MG | FORMULATION UNKNOWN | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127278291 | 12727829 | 1 | Prophylaxis against transplant rejection |
| 127278291 | 12727829 | 4 | Renal transplant |
| 127278291 | 12727829 | 7 | Renal transplant |
| 127278291 | 12727829 | 8 | Infection |
| 127278291 | 12727829 | 9 | Product used for unknown indication |
| 127278291 | 12727829 | 10 | Product used for unknown indication |
| 127278291 | 12727829 | 11 | Product used for unknown indication |
| 127278291 | 12727829 | 12 | Product used for unknown indication |
| 127278291 | 12727829 | 13 | Product used for unknown indication |
| 127278291 | 12727829 | 14 | Product used for unknown indication |
| 127278291 | 12727829 | 15 | Infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127278291 | 12727829 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127278291 | 12727829 | Pyrexia | |
| 127278291 | 12727829 | Status epilepticus |
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 |
|---|---|---|---|---|---|---|
| 127278291 | 12727829 | 1 | 20131022 | 20131116 | 0 | |
| 127278291 | 12727829 | 2 | 20131119 | 0 | ||
| 127278291 | 12727829 | 3 | 20131121 | 0 | ||
| 127278291 | 12727829 | 4 | 20131022 | 0 | ||
| 127278291 | 12727829 | 5 | 20131119 | 0 | ||
| 127278291 | 12727829 | 6 | 20131121 | 0 | ||
| 127278291 | 12727829 | 7 | 20131022 | 0 | ||
| 127278291 | 12727829 | 8 | 20031106 | 0 | ||
| 127278291 | 12727829 | 15 | 20131106 | 0 |