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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126317032 | 12631703 | 2 | F | 201512 | 20160729 | 20160808 | 20160809 | EXP | PHEH2016US019134 | SANDOZ | 33.00 | YR | M | Y | 0.00000 | 20160809 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126317032 | 12631703 | 1 | SS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 126317032 | 12631703 | 2 | SS | ELTROMBOPAG | ELTROMBOPAG | 1 | Unknown | U | 0 | ||||||||||
| 126317032 | 12631703 | 3 | SS | ELTROMBOPAG | ELTROMBOPAG | 1 | U | 0 | |||||||||||
| 126317032 | 12631703 | 4 | PS | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK | U | 80336 | |||||||||
| 126317032 | 12631703 | 5 | SS | RITUXIMAB | RITUXIMAB | 1 | Unknown | U | 0 | ||||||||||
| 126317032 | 12631703 | 6 | SS | BLINATUMOMAB | BLINATUMOMAB | 1 | Unknown | U | 0 | ||||||||||
| 126317032 | 12631703 | 7 | SS | VINCRISTINE | VINCRISTINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126317032 | 12631703 | 8 | SS | MERCAPTOPURINE. | MERCAPTOPURINE | 1 | Unknown | U | 0 | ||||||||||
| 126317032 | 12631703 | 9 | SS | PEG/L-ASPARAGINASE | PEGASPARGASE | 1 | Unknown | U | 0 | ||||||||||
| 126317032 | 12631703 | 10 | SS | MARQIBO | VINCRISTINE SULFATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126317032 | 12631703 | 11 | SS | MARQIBO | VINCRISTINE SULFATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126317032 | 12631703 | 12 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | PULSE DOSE Q2 WEEKS | U | 0 | |||||||||
| 126317032 | 12631703 | 13 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 40 MG, THE DAY OF AND THE DAY AFTER CYCLOPHOSPHAMIDE | U | 0 | 40 | MG | |||||||
| 126317032 | 12631703 | 14 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | 8 MG, QOD | U | 0 | 8 | MG | ||||||||
| 126317032 | 12631703 | 15 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 10 MG, QD | U | 0 | 10 | MG | QD | ||||||
| 126317032 | 12631703 | 16 | SS | METHOTREXATE. | METHOTREXATE | 1 | UNK | U | 0 | ||||||||||
| 126317032 | 12631703 | 17 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | UNK | U | 0 | |||||||||
| 126317032 | 12631703 | 18 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | UNK | U | 0 | |||||||||
| 126317032 | 12631703 | 19 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126317032 | 12631703 | 20 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126317032 | 12631703 | 21 | SS | CYTARABINE. | CYTARABINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126317032 | 12631703 | 22 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | U | 0 | ||||||||||
| 126317032 | 12631703 | 23 | SS | HYDROCORTISONE. | HYDROCORTISONE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126317032 | 12631703 | 24 | SS | HYDROCORTISONE. | HYDROCORTISONE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126317032 | 12631703 | 1 | Product used for unknown indication |
| 126317032 | 12631703 | 2 | Thrombocytopenia |
| 126317032 | 12631703 | 3 | Anaemia |
| 126317032 | 12631703 | 4 | Acute lymphocytic leukaemia refractory |
| 126317032 | 12631703 | 5 | Acute lymphocytic leukaemia refractory |
| 126317032 | 12631703 | 6 | Acute lymphocytic leukaemia refractory |
| 126317032 | 12631703 | 7 | Acute lymphocytic leukaemia refractory |
| 126317032 | 12631703 | 8 | Acute lymphocytic leukaemia refractory |
| 126317032 | 12631703 | 9 | Acute lymphocytic leukaemia refractory |
| 126317032 | 12631703 | 10 | Acute lymphocytic leukaemia refractory |
| 126317032 | 12631703 | 11 | Neuropathy peripheral |
| 126317032 | 12631703 | 12 | Acute lymphocytic leukaemia recurrent |
| 126317032 | 12631703 | 16 | Acute lymphocytic leukaemia refractory |
| 126317032 | 12631703 | 19 | Acute lymphocytic leukaemia refractory |
| 126317032 | 12631703 | 22 | Acute lymphocytic leukaemia recurrent |
| 126317032 | 12631703 | 23 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126317032 | 12631703 | OT |
| 126317032 | 12631703 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126317032 | 12631703 | Acute lymphocytic leukaemia recurrent | |
| 126317032 | 12631703 | Anaemia | |
| 126317032 | 12631703 | Back pain | |
| 126317032 | 12631703 | Bone marrow oedema | |
| 126317032 | 12631703 | Bone pain | |
| 126317032 | 12631703 | Deep vein thrombosis | |
| 126317032 | 12631703 | Leukocytosis | |
| 126317032 | 12631703 | Metapneumovirus infection | |
| 126317032 | 12631703 | Nausea | |
| 126317032 | 12631703 | Neck pain | |
| 126317032 | 12631703 | Neuropathy peripheral | |
| 126317032 | 12631703 | Pancytopenia | |
| 126317032 | 12631703 | Pyrexia | |
| 126317032 | 12631703 | Tachycardia | |
| 126317032 | 12631703 | Thrombocytopenia | |
| 126317032 | 12631703 | Upper respiratory tract infection |
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 |
|---|---|---|---|---|---|---|
| 126317032 | 12631703 | 4 | 201303 | 0 | ||
| 126317032 | 12631703 | 7 | 201303 | 0 | ||
| 126317032 | 12631703 | 11 | 20140214 | 0 | ||
| 126317032 | 12631703 | 16 | 201603 | 0 | ||
| 126317032 | 12631703 | 17 | 20160602 | 0 | ||
| 126317032 | 12631703 | 18 | 20160606 | 0 | ||
| 126317032 | 12631703 | 20 | 20160602 | 0 | ||
| 126317032 | 12631703 | 21 | 20160606 | 0 | ||
| 126317032 | 12631703 | 23 | 20160602 | 0 | ||
| 126317032 | 12631703 | 24 | 20160606 | 0 |