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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125402762 | 12540276 | 2 | F | 20150901 | 20160712 | 20160708 | 20160719 | EXP | FR-ARIAD PHARMACEUTICALS, INC-2016FR006539 | ARIAD | 16.00 | YR | M | Y | 44.90000 | KG | 20160719 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125402762 | 12540276 | 1 | PS | ICLUSIG | PONATINIB | 1 | Oral | 30 MG, QD | 6900 | MG | Y | N | NOT REPORTED | 203469 | 30 | MG | TABLET | ||
| 125402762 | 12540276 | 2 | SS | ICLUSIG | PONATINIB | 1 | Oral | 45 MG, QD | 6900 | MG | Y | N | NOT PROVIDED | 203469 | 45 | MG | TABLET | ||
| 125402762 | 12540276 | 3 | SS | ICLUSIG | PONATINIB | 1 | 30 MG, QD | 6900 | MG | Y | N | NOT PROVIDED | 203469 | 30 | MG | TABLET | |||
| 125402762 | 12540276 | 4 | SS | ICLUSIG | PONATINIB | 1 | Oral | 45 MG, QD | 6900 | MG | Y | N | NOT PROVIDED | 203469 | 45 | MG | TABLET | ||
| 125402762 | 12540276 | 5 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 55 MG, UNK | Y | 0 | 55 | MG | |||||||
| 125402762 | 12540276 | 6 | SS | Vincristine | VINCRISTINE | 1 | Intravenous (not otherwise specified) | UNK | Y | 0 | |||||||||
| 125402762 | 12540276 | 7 | SS | Zyvoxid | LINEZOLID | 1 | Oral | 400 MG, BID | 12000 | MG | Y | 0 | 400 | MG | |||||
| 125402762 | 12540276 | 8 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 4 MG, BID | 0 | 4 | MG | ||||||||
| 125402762 | 12540276 | 9 | C | Zelitrex | VALACYCLOVIR HYDROCHLORIDE | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125402762 | 12540276 | 1 | Acute lymphocytic leukaemia |
| 125402762 | 12540276 | 5 | Product used for unknown indication |
| 125402762 | 12540276 | 6 | Acute lymphocytic leukaemia |
| 125402762 | 12540276 | 7 | Infection |
| 125402762 | 12540276 | 8 | Product used for unknown indication |
| 125402762 | 12540276 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125402762 | 12540276 | OT |
| 125402762 | 12540276 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125402762 | 12540276 | Acute lymphocytic leukaemia recurrent | |
| 125402762 | 12540276 | Drug ineffective | |
| 125402762 | 12540276 | Dyspepsia | |
| 125402762 | 12540276 | Hepatocellular injury | |
| 125402762 | 12540276 | Infection | |
| 125402762 | 12540276 | Off label use | |
| 125402762 | 12540276 | Rash erythematous | |
| 125402762 | 12540276 | Scleroderma |
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 |
|---|---|---|---|---|---|---|
| 125402762 | 12540276 | 1 | 20151001 | 20160502 | 0 | |
| 125402762 | 12540276 | 2 | 20160508 | 20160524 | 0 | |
| 125402762 | 12540276 | 3 | 20160525 | 20160606 | 0 | |
| 125402762 | 12540276 | 4 | 20160607 | 0 | ||
| 125402762 | 12540276 | 5 | 20160503 | 20160511 | 0 | |
| 125402762 | 12540276 | 6 | 20160507 | 20160507 | 0 | |
| 125402762 | 12540276 | 7 | 20160503 | 20160517 | 0 |