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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126931811 | 12693181 | 1 | I | 201604 | 20160707 | 20160829 | 20160829 | EXP | FR-ASTELLAS-2016US026465 | ASTELLAS | 66.25 | YR | M | Y | 0.00000 | 20160829 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126931811 | 12693181 | 1 | PS | Advagraf | TACROLIMUS | 1 | Oral | UNK, UNKNOWN FREQ. | 204096 | MODIFIED-RELEASE CAPSULE, HARD | |||||||||
| 126931811 | 12693181 | 2 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126931811 | 12693181 | 3 | C | RYTHMOL /00546302/ | 2 | Oral | 0.5 ON MORNING AND 0.5 ON EVENING | U | 0 | .5 | MG | FORMULATION UNKNOWN | BID | ||||||
| 126931811 | 12693181 | 4 | C | ATACAND | CANDESARTAN CILEXETIL | 1 | Oral | 1 DF, ON MORNING ONCE DAILY | U | 0 | 1 | DF | FORMULATION UNKNOWN | QD | |||||
| 126931811 | 12693181 | 5 | C | ZYLORIC | ALLOPURINOL | 1 | Oral | 1 DF, ON MORNING | U | 0 | 1 | DF | FORMULATION UNKNOWN | QD | |||||
| 126931811 | 12693181 | 6 | C | MIRCERA | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA | 1 | Unknown | UNK UNK, MONTHLY | U | 0 | INJECTION | /month | |||||||
| 126931811 | 12693181 | 7 | C | SODIUM BICARBONATE. | SODIUM BICARBONATE | 1 | Oral | 1 DF, ONE ON MORNING AND ONE ON EVENING | U | 0 | 1 | DF | FORMULATION UNKNOWN | BID | |||||
| 126931811 | 12693181 | 8 | C | BURINEX | BUMETANIDE | 1 | Oral | 1 DF, ONCE DAILY ON MORNING | U | 0 | 1 | DF | FORMULATION UNKNOWN | QD | |||||
| 126931811 | 12693181 | 9 | C | ALPRESS LP | PRAZOSIN HYDROCHLORIDE | 1 | Oral | U | 0 | 1 | DF | FORMULATION UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126931811 | 12693181 | 1 | Prophylaxis against transplant rejection |
| 126931811 | 12693181 | 2 | Prophylaxis against transplant rejection |
| 126931811 | 12693181 | 3 | Blood pressure abnormal |
| 126931811 | 12693181 | 4 | Blood pressure abnormal |
| 126931811 | 12693181 | 5 | Blood uric acid abnormal |
| 126931811 | 12693181 | 6 | Red blood cell abnormality |
| 126931811 | 12693181 | 7 | Product used for unknown indication |
| 126931811 | 12693181 | 8 | Diuretic therapy |
| 126931811 | 12693181 | 9 | Blood pressure abnormal |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126931811 | 12693181 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126931811 | 12693181 | Diarrhoea | |
| 126931811 | 12693181 | Graft loss | |
| 126931811 | 12693181 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 126931811 | 12693181 | 1 | 2012 | 0 | ||
| 126931811 | 12693181 | 2 | 2008 | 0 | ||
| 126931811 | 12693181 | 3 | 2008 | 0 | ||
| 126931811 | 12693181 | 4 | 2008 | 0 | ||
| 126931811 | 12693181 | 5 | 2008 | 0 | ||
| 126931811 | 12693181 | 7 | 2008 | 0 | ||
| 126931811 | 12693181 | 8 | 2008 | 0 |