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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127965403 | 12796540 | 3 | F | 20160920 | 20160929 | 20160930 | EXP | PHEH2016US024042 | SANDOZ | 0.00 | F | Y | 58.97000 | KG | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127965403 | 12796540 | 1 | SS | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | UNK | Y | 0 | |||||||||
| 127965403 | 12796540 | 2 | PS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 80339 | |||||||||||
| 127965403 | 12796540 | 3 | SS | RAPAMUNE | SIROLIMUS | 1 | Unknown | 1 MG, BID | 0 | 1 | MG | TABLET | BID | ||||||
| 127965403 | 12796540 | 4 | C | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127965403 | 12796540 | 1 | Renal transplant |
| 127965403 | 12796540 | 2 | Product used for unknown indication |
| 127965403 | 12796540 | 3 | Renal transplant |
| 127965403 | 12796540 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127965403 | 12796540 | HO |
| 127965403 | 12796540 | LT |
| 127965403 | 12796540 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127965403 | 12796540 | Burning sensation | |
| 127965403 | 12796540 | Colitis | |
| 127965403 | 12796540 | Diabetes mellitus | |
| 127965403 | 12796540 | Diarrhoea | |
| 127965403 | 12796540 | Feeling abnormal | |
| 127965403 | 12796540 | Glycosylated haemoglobin increased | |
| 127965403 | 12796540 | Malaise | |
| 127965403 | 12796540 | Pyrexia | |
| 127965403 | 12796540 | Somnolence | |
| 127965403 | 12796540 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 127965403 | 12796540 | 1 | 20111201 | 0 | ||
| 127965403 | 12796540 | 3 | 201607 | 0 |