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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
111577237 | 11157723 | 7 | F | 20150513 | 20160824 | 20150603 | 20160830 | EXP | PHHO2015US008648 | SANDOZ | 6.77 | YR | M | Y | 0.00000 | 20160830 | MD | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
111577237 | 11157723 | 1 | SS | CTL019 | TISAGENLECLEUCEL-T | 1 | Intravenous (not otherwise specified) | 4 X 10^6 CELLS/KG | 0 | ||||||||||
111577237 | 11157723 | 2 | PS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 30 MG/M2, UNK | 22137 | 30 | MG/M**2 | ||||||||
111577237 | 11157723 | 3 | SS | CYTOXAN | CYCLOPHOSPHAMIDE | 1 | Unknown | 500 MG/M2, UNK | 0 | 500 | MG/M**2 | ||||||||
111577237 | 11157723 | 4 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Oral | 50 MG, QD | 700 | MG | U | 0 | 50 | MG | QD | ||||
111577237 | 11157723 | 5 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Oral | 50 MG, QD | 700 | MG | U | 0 | 50 | MG | QD | ||||
111577237 | 11157723 | 6 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 40 MG, BID (THREE TIMES/WEEK) | 1120 | MG | U | 0 | 40 | MG | BID | ||||
111577237 | 11157723 | 7 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 40 MG, BID (THREE TIMES/WEEK) | 1120 | MG | U | 0 | 40 | MG | BID |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
111577237 | 11157723 | 1 | Acute lymphocytic leukaemia |
111577237 | 11157723 | 2 | Acute lymphocytic leukaemia |
111577237 | 11157723 | 3 | Acute lymphocytic leukaemia |
111577237 | 11157723 | 4 | Prophylaxis |
111577237 | 11157723 | 6 | Prophylaxis |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
111577237 | 11157723 | OT |
111577237 | 11157723 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
111577237 | 11157723 | Cytokine release syndrome | |
111577237 | 11157723 | Febrile neutropenia | |
111577237 | 11157723 | Left ventricular dysfunction | |
111577237 | 11157723 | Neutropenic colitis | |
111577237 | 11157723 | Respiratory distress |
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 |
---|---|---|---|---|---|---|
111577237 | 11157723 | 1 | 20150512 | 0 | ||
111577237 | 11157723 | 2 | 20150504 | 20150507 | 0 | |
111577237 | 11157723 | 3 | 20150504 | 20150505 | 0 | |
111577237 | 11157723 | 4 | 20150430 | 20150513 | 0 | |
111577237 | 11157723 | 5 | 20150610 | 0 | ||
111577237 | 11157723 | 6 | 20150430 | 20150520 | 0 | |
111577237 | 11157723 | 7 | 20150609 | 0 |