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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127070141 | 12707014 | 1 | I | 20160519 | 20160520 | 20160901 | 20160901 | EXP | PHJP2016JP013179 | NOVARTIS | 0.00 | A | M | Y | 0.00000 | 20160901 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127070141 | 12707014 | 1 | PS | TASIGNA | NILOTINIB | 1 | Oral | 600 MG, QD | 22068 | 600 | MG | CAPSULE | QD | ||||||
| 127070141 | 12707014 | 2 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127070141 | 12707014 | 1 | Acute lymphocytic leukaemia |
| 127070141 | 12707014 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127070141 | 12707014 | DE |
| 127070141 | 12707014 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127070141 | 12707014 | Acute lymphocytic leukaemia | |
| 127070141 | 12707014 | Anaemia | |
| 127070141 | 12707014 | Leukopenia | |
| 127070141 | 12707014 | Neutropenia | |
| 127070141 | 12707014 | Pancytopenia | |
| 127070141 | 12707014 | Product use issue | |
| 127070141 | 12707014 | Pyrexia | |
| 127070141 | 12707014 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 127070141 | 12707014 | 1 | 20160519 | 201606 | 0 | |
| 127070141 | 12707014 | 2 | 20160519 | 0 |