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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125608283 | 12560828 | 3 | F | 20160706 | 20160823 | 20160715 | 20160830 | EXP | US-ASTELLAS-2016US026158 | ASTELLAS | 58.98 | YR | M | Y | 0.00000 | 20160830 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125608283 | 12560828 | 1 | PS | CRESEMBA | ISAVUCONAZONIUM SULFATE | 1 | Intravenous (not otherwise specified) | 372 MG, 372 MG IV Q8H X 6 DOSES, FOLLOWED BY 372 MG IV Q24H | U | 207501 | 372 | MG | INJECTION | ||||||
| 125608283 | 12560828 | 2 | SS | AMBISOME | AMPHOTERICIN B | 1 | Intravenous (not otherwise specified) | 550 MG, 5 MG/KG IV Q24H (550 MG IV Q24H) | U | 0 | 550 | MG | INJECTION | QD | |||||
| 125608283 | 12560828 | 3 | SS | AMBISOME | AMPHOTERICIN B | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | INJECTION | ||||||||
| 125608283 | 12560828 | 4 | C | ASPIRIN. | ASPIRIN | 1 | Oral | U | 0 | 81 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125608283 | 12560828 | 5 | C | FAMOTIDINE. | FAMOTIDINE | 1 | Oral | U | 0 | 20 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125608283 | 12560828 | 6 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | U | 0 | 1 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125608283 | 12560828 | 7 | C | INSULIN | INSULIN NOS | 1 | Subcutaneous | UNK REGULAR INSULIN WITH MEALS, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 125608283 | 12560828 | 8 | C | INSULIN GLARGINE | INSULIN GLARGINE | 1 | Subcutaneous | U | 0 | 18 | IU | FORMULATION UNKNOWN | QD | ||||||
| 125608283 | 12560828 | 9 | C | LIDODERM | LIDOCAINE | 1 | Topical | UNK UNK, EVERY 24 HOURS | U | 0 | FORMULATION UNKNOWN | QD | |||||||
| 125608283 | 12560828 | 10 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | U | 0 | 20 | MG | FORMULATION UNKNOWN | BID | ||||||
| 125608283 | 12560828 | 11 | C | LORATADINE. | LORATADINE | 1 | Oral | U | 0 | 10 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125608283 | 12560828 | 12 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | Oral | U | 0 | 800 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125608283 | 12560828 | 13 | C | PAROXETINE. | PAROXETINE | 1 | Oral | U | 0 | 5 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125608283 | 12560828 | 14 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Oral | U | 0 | 20 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125608283 | 12560828 | 15 | C | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 10 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125608283 | 12560828 | 16 | C | TACROLIMUS. | TACROLIMUS | 1 | Oral | 0.5 MG, EVERY 48 HOURS | U | 0 | .5 | MG | CAPSULE | QOD | |||||
| 125608283 | 12560828 | 17 | C | Tamsulosin | TAMSULOSIN | 1 | Oral | 0.4 MG, ONCE DAILY | U | 0 | .4 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125608283 | 12560828 | 1 | Product used for unknown indication |
| 125608283 | 12560828 | 2 | Product used for unknown indication |
| 125608283 | 12560828 | 4 | Product used for unknown indication |
| 125608283 | 12560828 | 5 | Product used for unknown indication |
| 125608283 | 12560828 | 6 | Product used for unknown indication |
| 125608283 | 12560828 | 7 | Product used for unknown indication |
| 125608283 | 12560828 | 8 | Product used for unknown indication |
| 125608283 | 12560828 | 9 | Product used for unknown indication |
| 125608283 | 12560828 | 10 | Product used for unknown indication |
| 125608283 | 12560828 | 11 | Product used for unknown indication |
| 125608283 | 12560828 | 12 | Product used for unknown indication |
| 125608283 | 12560828 | 13 | Product used for unknown indication |
| 125608283 | 12560828 | 14 | Product used for unknown indication |
| 125608283 | 12560828 | 15 | Product used for unknown indication |
| 125608283 | 12560828 | 16 | Product used for unknown indication |
| 125608283 | 12560828 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125608283 | 12560828 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125608283 | 12560828 | Cardio-respiratory arrest | |
| 125608283 | 12560828 | Endotracheal intubation | |
| 125608283 | 12560828 | Hypersensitivity | |
| 125608283 | 12560828 | Pulse absent |
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 |
|---|---|---|---|---|---|---|
| 125608283 | 12560828 | 1 | 20160706 | 20160707 | 0 | |
| 125608283 | 12560828 | 2 | 20160706 | 20160713 | 0 | |
| 125608283 | 12560828 | 3 | 20160715 | 0 | ||
| 125608283 | 12560828 | 4 | 201510 | 0 | ||
| 125608283 | 12560828 | 5 | 20160411 | 0 | ||
| 125608283 | 12560828 | 6 | 20160411 | 0 | ||
| 125608283 | 12560828 | 9 | 20151228 | 0 | ||
| 125608283 | 12560828 | 10 | 20160411 | 0 | ||
| 125608283 | 12560828 | 11 | 20151015 | 0 | ||
| 125608283 | 12560828 | 12 | 20150519 | 0 | ||
| 125608283 | 12560828 | 13 | 20151229 | 0 | ||
| 125608283 | 12560828 | 14 | 20160411 | 0 | ||
| 125608283 | 12560828 | 15 | 20160209 | 0 | ||
| 125608283 | 12560828 | 16 | 20160402 | 0 | ||
| 125608283 | 12560828 | 17 | 20151015 | 0 |