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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126020153 | 12602015 | 3 | F | 20160923 | 20160728 | 20160926 | EXP | US-PFIZER INC-2016000551 | PFIZER | 57.00 | YR | M | Y | 73.00000 | KG | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126020153 | 12602015 | 1 | PS | RAPAMUNE | SIROLIMUS | 1 | Oral | 2 MG, DAILY | L03350 | 21110 | 2 | MG | TABLET | ||||||
| 126020153 | 12602015 | 2 | SS | RAPAMUNE | SIROLIMUS | 1 | Oral | 2 MG, DAILY | J99300 | 21110 | 2 | MG | TABLET | ||||||
| 126020153 | 12602015 | 3 | SS | RAPAMUNE | SIROLIMUS | 1 | UNK | M85173 | 21110 | TABLET | |||||||||
| 126020153 | 12602015 | 4 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 250 MG, 2X/DAY | 0 | 250 | MG | TABLET | BID | ||||||
| 126020153 | 12602015 | 5 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 5 MG, 1X/DAY | 0 | 5 | MG | TABLET | QD | ||||||
| 126020153 | 12602015 | 6 | C | PREDNISONE. | PREDNISONE | 1 | 0 | TABLET | |||||||||||
| 126020153 | 12602015 | 7 | C | NIFEDIPINE. | NIFEDIPINE | 1 | Oral | 30 MG, 1X/DAY | 0 | 30 | MG | MODIFIED-RELEASE TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126020153 | 12602015 | 1 | Renal transplant |
| 126020153 | 12602015 | 4 | Renal transplant |
| 126020153 | 12602015 | 5 | Renal transplant |
| 126020153 | 12602015 | 6 | Renal disorder |
| 126020153 | 12602015 | 7 | Blood pressure inadequately controlled |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126020153 | 12602015 | OT |
| 126020153 | 12602015 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126020153 | 12602015 | Atrial fibrillation | |
| 126020153 | 12602015 | Influenza | |
| 126020153 | 12602015 | Loss of consciousness | |
| 126020153 | 12602015 | Nasopharyngitis | |
| 126020153 | 12602015 | Poor quality drug administered | |
| 126020153 | 12602015 | Product packaging issue | |
| 126020153 | 12602015 | Product physical issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |