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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125653902 | 12565390 | 2 | F | 20160603 | 20160817 | 20160718 | 20160823 | EXP | CA-OTSUKA-2016_012457 | OTSUKA | 68.66 | YR | M | Y | 78.30000 | KG | 20160823 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125653902 | 12565390 | 1 | PS | BUSULFAN. | BUSULFAN | 1 | Intravenous (not otherwise specified) | 216 MG, Q 24 HOURS X 3 DAYS | 648 | MG | 20955 | 216 | MG | INJECTION | QD | ||||
| 125653902 | 12565390 | 2 | SS | *Lenalidomide | LENALIDOMIDE | 1 | Oral | 10 MG, QD | 5450 | MG | 0 | 10 | MG | CAPSULE | QD | ||||
| 125653902 | 12565390 | 3 | SS | *Lenalidomide | LENALIDOMIDE | 1 | Oral | 15 MG, QD | 5450 | MG | 0 | 15 | MG | CAPSULE | QD | ||||
| 125653902 | 12565390 | 4 | SS | *Melphalan | MELPHALAN | 1 | Intravenous (not otherwise specified) | 250 MG, SINGLE | 250 | MG | 0 | 250 | MG | INJECTION | QD | ||||
| 125653902 | 12565390 | 5 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | BD | 0 | ||||||||||
| 125653902 | 12565390 | 6 | C | GLICLAZIDE | GLICLAZIDE | 1 | Oral | 40 MG, QD | 0 | 40 | MG | QD | |||||||
| 125653902 | 12565390 | 7 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 112.5 MG | 0 | 112.5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125653902 | 12565390 | 1 | Stem cell transplant |
| 125653902 | 12565390 | 2 | Stem cell transplant |
| 125653902 | 12565390 | 4 | Stem cell transplant |
| 125653902 | 12565390 | 5 | Product used for unknown indication |
| 125653902 | 12565390 | 6 | Product used for unknown indication |
| 125653902 | 12565390 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125653902 | 12565390 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125653902 | 12565390 | Leukaemia |
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 |
|---|---|---|---|---|---|---|
| 125653902 | 12565390 | 1 | 20150109 | 20150111 | 0 | |
| 125653902 | 12565390 | 2 | 20150429 | 20150726 | 0 | |
| 125653902 | 12565390 | 3 | 20150727 | 20160525 | 0 | |
| 125653902 | 12565390 | 4 | 20150112 | 20150112 | 0 |