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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126341911 | 12634191 | 1 | I | 20160729 | 20160808 | 20160808 | EXP | PHHY2016US106578 | SANDOZ | PURI K, KOCOSHIS S, RISMA K, PEREZ L, HART C, CHIN C ET AL.. BASILIXIMAB TREATMENT FOR AUTOIMMUNE BOWEL DISEASE IN A PEDIATRIC HEART TRANSPLANT PATIENT. PEDIATRIC TRANSPLANTATION. 2015;19(7):E165-9 | 28.00 | MON | F | Y | 0.00000 | 20160808 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126341911 | 12634191 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 800 MG/M2, QD | U | 65379 | 800 | MG/M**2 | QD | ||||||
| 126341911 | 12634191 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 10-12 NG/ML | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126341911 | 12634191 | 1 | Immunosuppressant drug therapy |
| 126341911 | 12634191 | 2 | Immunosuppressant drug therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126341911 | 12634191 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126341911 | 12634191 | Bacterial infection | |
| 126341911 | 12634191 | Enterocolitis | |
| 126341911 | 12634191 | Leukopenia | |
| 126341911 | 12634191 | Tracheo-oesophageal fistula | |
| 126341911 | 12634191 | Viral infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |