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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126675291 | 12667529 | 1 | I | 20160812 | 20160819 | 20160819 | EXP | JP-MYLANLABS-2016M1034700 | MYLAN | SAKURADA M, KONDO T, UMEDA M, KAWABATA H, YAMASHITA K, TAKAORI-KONDO A. SUCCESSFUL TREATMENT WITH INTRAVESICAL CIDOFOVIR FOR VIRUS-ASSOCIATED HEMORRHAGIC CYSTITIS AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION: A CASE REPORT AND A REVIEW OF THE LITERATURE. J-INFECT-CHEMOTHER 2016;22(7):495-500. | 0.00 | Y | 0.00000 | 20160819 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126675291 | 12667529 | 1 | PS | CIDOFOVIR. | CIDOFOVIR | 1 | Intravenous (not otherwise specified) | 1 MG/KG THRICE A WEEK FOR TOTAL OF 7 DOSES | Y | U | 201276 | INJECTION | |||||||
| 126675291 | 12667529 | 2 | SS | CIDOFOVIR. | CIDOFOVIR | 1 | Intravesical | 2 MG/KG DILUTED IN 100ML OF SALINE GIVEN OVER 15 MINS | Y | U | 201276 | INJECTION | |||||||
| 126675291 | 12667529 | 3 | SS | BUSULFAN. | BUSULFAN | 1 | Intravenous (not otherwise specified) | 8.5 MG/KG FOR 2 DAYS | U | U | 0 | INJECTION | |||||||
| 126675291 | 12667529 | 4 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | Intravesical | CIDOFOVIR WAS DILUTED IN 100ML OF SALINE | 0 | ||||||||||
| 126675291 | 12667529 | 5 | C | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 25 MG/M2, 5 DAYS | 0 | ||||||||||
| 126675291 | 12667529 | 6 | C | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | |||||||||||
| 126675291 | 12667529 | 7 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | |||||||||||
| 126675291 | 12667529 | 8 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 0 | |||||||||||
| 126675291 | 12667529 | 9 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 15 MG/DAY | 0 | ||||||||||
| 126675291 | 12667529 | 10 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 15 MG/DAY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126675291 | 12667529 | 1 | Adenoviral haemorrhagic cystitis |
| 126675291 | 12667529 | 3 | Acute myeloid leukaemia |
| 126675291 | 12667529 | 4 | Adenoviral haemorrhagic cystitis |
| 126675291 | 12667529 | 5 | Acute myeloid leukaemia |
| 126675291 | 12667529 | 6 | Prophylaxis against graft versus host disease |
| 126675291 | 12667529 | 7 | Prophylaxis against graft versus host disease |
| 126675291 | 12667529 | 8 | Prophylaxis against graft versus host disease |
| 126675291 | 12667529 | 9 | Graft versus host disease |
| 126675291 | 12667529 | 10 | Hepatic function abnormal |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126675291 | 12667529 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126675291 | 12667529 | Adenoviral haemorrhagic cystitis | |
| 126675291 | 12667529 | Bladder irritation |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |