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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127087511 | 12708751 | 1 | I | 20160809 | 20160901 | 20160901 | EXP | US-SA-2016SA147854 | AVENTIS | RAMAY FH, AMOROSO A, VON ROSENVINGE EC, SAHARIA K. FECAL MICROBIOTA TRANSPLANTATION FOR TREATMENT OF SEVERE, RECURRENT, AND REFRACTORY CLOSTRIDIUM DIFFICILE INFECTION IN A SEVERELY IMMUNOCOMPROMISED PATIENT. INFECTIOUS DISEASES IN CLINICAL PRACTICE. 2016 NOV 04;24(4):237-40. | 65.00 | YR | E | M | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127087511 | 12708751 | 1 | PS | ANTI-THYMOCYTE GLOBULIN (RABBIT) | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | UNKNOWN | 103869 | ||||||||||
| 127087511 | 12708751 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | Y | UNK | 0 | |||||||||
| 127087511 | 12708751 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | Y | 0 | 2.5 | MG | QD | |||||||
| 127087511 | 12708751 | 4 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | Y | UNK | 0 | 150 | MG | BID | ||||||
| 127087511 | 12708751 | 5 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | Y | UNK | 0 | 250 | MG | BID | ||||||
| 127087511 | 12708751 | 6 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | Y | UNK | 0 | 500 | MG | BID | ||||||
| 127087511 | 12708751 | 7 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | Y | UNK | 0 | |||||||||
| 127087511 | 12708751 | 8 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | DOSE DECREASED TO 4 TO 6 NG/ML | Y | 0 | |||||||||
| 127087511 | 12708751 | 9 | C | DAPSONE. | DAPSONE | 1 | 0 | ||||||||||||
| 127087511 | 12708751 | 10 | C | VALGANCICLOVIR. | VALGANCICLOVIR | 1 | 0 | ||||||||||||
| 127087511 | 12708751 | 11 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | 0 | ||||||||||||
| 127087511 | 12708751 | 12 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127087511 | 12708751 | 1 | Immunosuppression |
| 127087511 | 12708751 | 2 | Immunosuppression |
| 127087511 | 12708751 | 3 | Immunosuppression |
| 127087511 | 12708751 | 4 | Immunosuppression |
| 127087511 | 12708751 | 5 | Immunosuppression |
| 127087511 | 12708751 | 6 | Immunosuppression |
| 127087511 | 12708751 | 7 | Immunosuppression |
| 127087511 | 12708751 | 8 | Immunosuppression |
| 127087511 | 12708751 | 9 | Infection prophylaxis |
| 127087511 | 12708751 | 10 | Infection prophylaxis |
| 127087511 | 12708751 | 11 | Infection prophylaxis |
| 127087511 | 12708751 | 12 | Infection prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127087511 | 12708751 | HO |
| 127087511 | 12708751 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127087511 | 12708751 | Abdominal pain | |
| 127087511 | 12708751 | Acute kidney injury | |
| 127087511 | 12708751 | Clostridium difficile colitis | |
| 127087511 | 12708751 | Dehydration | |
| 127087511 | 12708751 | Diarrhoea | |
| 127087511 | 12708751 | Malaise | |
| 127087511 | 12708751 | Pseudomembranous colitis | |
| 127087511 | 12708751 | Pyrexia | |
| 127087511 | 12708751 | Urinary tract infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |