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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126152481 | 12615248 | 1 | I | 2011 | 20160727 | 20160802 | 20160802 | EXP | RS-MYLANLABS-2016M1031474 | MYLAN | COLOVIC N, SEFEROVIC P, PLECIC M, VIDOVIC A, SUVAJDZIC N, TOMIN D. PERIPARTUM CARDIOMYOPATHY IN A PATIENT TREATED FOR ACUTE MYELOID LEUKEMIA. SRP-ARH-CELOK-LEK 2016;144:77-80. | 0.00 | Y | 0.00000 | 20160802 | OT | RS | RS |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126152481 | 12615248 | 1 | PS | BROMOCRIPTINE | BROMOCRIPTINE | 1 | Unknown | Y | U | 76962 | |||||||||
| 126152481 | 12615248 | 2 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | 60 MG ON DAY 1 OF THE CYCLE | 360 | MG | U | 0 | |||||||
| 126152481 | 12615248 | 3 | SS | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | U | 0 | ||||||||||
| 126152481 | 12615248 | 4 | SS | ITRACONAZOLE. | ITRACONAZOLE | 1 | Unknown | U | 0 | ||||||||||
| 126152481 | 12615248 | 5 | SS | MITOXANTRONE | MITOXANTRONE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 15 MG FROM DAY 1-4 OF THE CYCLE | 60 | MG | U | U | 0 | ||||||
| 126152481 | 12615248 | 6 | SS | VORICONAZOLE MYLAN | VORICONAZOLE | 1 | Unknown | U | 0 | ||||||||||
| 126152481 | 12615248 | 7 | SS | AMPHOTERICIN B. | AMPHOTERICIN B | 1 | Unknown | U | 0 | ||||||||||
| 126152481 | 12615248 | 8 | C | CYTARABINE. | CYTARABINE | 1 | Intravenous bolus | 2X140 MG FROM DAY 1 TO DAY 8 OF THE CYCLE | U | 0 | |||||||||
| 126152481 | 12615248 | 9 | C | CYTARABINE. | CYTARABINE | 1 | Intravenous drip | 2X150 MG FROM DAY 1 TO DAY 5 OF THE CYCLE | U | 0 | |||||||||
| 126152481 | 12615248 | 10 | C | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | 3G FROM DAY 1 TO DAY 3 OF THE CYCLE | U | 0 | |||||||||
| 126152481 | 12615248 | 11 | C | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 140 MG IN ONE HOUR INFUSION FROM DAY 1 TO DAY 5 OF THE CYCLE | U | 0 | |||||||||
| 126152481 | 12615248 | 12 | C | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 150 MG FROM DAY 1 TO DAY 5 OF THE CYCLE | U | 0 | |||||||||
| 126152481 | 12615248 | 13 | C | AMSACRINE | AMSACRINE | 1 | Intravenous (not otherwise specified) | 15 MG FROM DAY 1 TO DAY 5 OF THE CYCLE | U | 0 | |||||||||
| 126152481 | 12615248 | 14 | C | DOBUTAMINE | DOBUTAMINEDOBUTAMINE HYDROCHLORIDE | 1 | Unknown | U | U | 0 | |||||||||
| 126152481 | 12615248 | 15 | C | HEPARIN | HEPARIN SODIUM | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126152481 | 12615248 | 2 | Acute myeloid leukaemia |
| 126152481 | 12615248 | 3 | Hepatosplenic candidiasis |
| 126152481 | 12615248 | 4 | Hepatosplenic candidiasis |
| 126152481 | 12615248 | 5 | Acute myeloid leukaemia |
| 126152481 | 12615248 | 6 | Hepatosplenic candidiasis |
| 126152481 | 12615248 | 7 | Hepatosplenic candidiasis |
| 126152481 | 12615248 | 8 | Acute myeloid leukaemia |
| 126152481 | 12615248 | 11 | Acute myeloid leukaemia |
| 126152481 | 12615248 | 13 | Acute myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126152481 | 12615248 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126152481 | 12615248 | Caesarean section | |
| 126152481 | 12615248 | Cardiac failure | |
| 126152481 | 12615248 | Cardiomegaly | |
| 126152481 | 12615248 | Exposure during pregnancy | |
| 126152481 | 12615248 | Hepatosplenic candidiasis | |
| 126152481 | 12615248 | Nausea | |
| 126152481 | 12615248 | Peripartum cardiomyopathy | |
| 126152481 | 12615248 | Pleural effusion | |
| 126152481 | 12615248 | Somnolence | |
| 126152481 | 12615248 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126152481 | 12615248 | 5 | 200411 | 0 | ||
| 126152481 | 12615248 | 9 | 200409 | 0 | ||
| 126152481 | 12615248 | 10 | 200411 | 0 | ||
| 126152481 | 12615248 | 12 | 200409 | 0 | ||
| 126152481 | 12615248 | 13 | 200409 | 0 |