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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125366212 | 12536621 | 2 | F | 201603 | 20160726 | 20160707 | 20160816 | PER | US-PFIZER INC-2016291687 | PFIZER | 65.00 | YR | M | Y | 86.00000 | KG | 20160816 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125366212 | 12536621 | 1 | PS | RAPAMUNE | SIROLIMUS | 1 | 3.5MG, TABLETS, PER DAY, IN THE MORNING | L91585 | 21110 | 2.5 | MG | TABLET | |||||||
| 125366212 | 12536621 | 2 | SS | RAPAMUNE | SIROLIMUS | 1 | 3.5MG, TABLETS, PER DAY, IN THE MORNING | M40040 | 21110 | 2.5 | MG | TABLET | |||||||
| 125366212 | 12536621 | 3 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 100 MG, 1X/DAY | 0 | 100 | MG | QD | ||||||||
| 125366212 | 12536621 | 4 | C | TACROLIMUS. | TACROLIMUS | 1 | 2MG AM, 2MG PM DAILY | 0 | 4 | MG | |||||||||
| 125366212 | 12536621 | 5 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | 250 MG, ONE IN AM AND ONE IN PM DAILY | 0 | 500 | MG | |||||||||
| 125366212 | 12536621 | 6 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 10MG PM DAILY ONCE | 0 | 10 | MG | QD | ||||||||
| 125366212 | 12536621 | 7 | C | MAGNESIUM CALCIUM | 2 | 143 MG, DAILY | 0 | 143 | MG | ||||||||||
| 125366212 | 12536621 | 8 | C | FLUDROCORTISONE | FLUDROCORTISONE | 1 | 0.1 MG, 1X/DAY | 0 | .1 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125366212 | 12536621 | 1 | Transplant rejection |
| 125366212 | 12536621 | 3 | Thyroid disorder |
| 125366212 | 12536621 | 4 | Transplant rejection |
| 125366212 | 12536621 | 5 | Transplant rejection |
| 125366212 | 12536621 | 6 | Antibiotic prophylaxis |
| 125366212 | 12536621 | 8 | Transplant rejection |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125366212 | 12536621 | Mouth ulceration | |
| 125366212 | 12536621 | Product use issue | |
| 125366212 | 12536621 | Rash |
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 |
|---|---|---|---|---|---|---|
| 125366212 | 12536621 | 1 | 2016 | 0 | ||
| 125366212 | 12536621 | 2 | 2016 | 0 | ||
| 125366212 | 12536621 | 3 | 2013 | 0 | ||
| 125366212 | 12536621 | 4 | 2013 | 0 | ||
| 125366212 | 12536621 | 5 | 2013 | 0 | ||
| 125366212 | 12536621 | 6 | 2013 | 0 | ||
| 125366212 | 12536621 | 8 | 2014 | 0 |