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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121888562 | 12188856 | 2 | F | 20151223 | 20160728 | 20160317 | 20160803 | EXP | PHHO2016US002138 | SANDOZ | 17.48 | YR | F | Y | 98.60000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121888562 | 12188856 | 1 | SS | CTL019 | TISAGENLECLEUCEL-T | 1 | Intravenous (not otherwise specified) | TOTAL CELL DOSE:0.2418X10^9, TOTAL TRANSDUCED CELLS1X10^6/KG | 0 | ||||||||||
| 121888562 | 12188856 | 2 | PS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 30 MG/M2, UNK | U | 22137 | 30 | MG/M**2 | |||||||
| 121888562 | 12188856 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 500 MG/M2X 3 DAYS | U | 0 | 500 | MG/M**2 | |||||||
| 121888562 | 12188856 | 4 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 121888562 | 12188856 | 5 | C | MTX | METHOTREXATE SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 121888562 | 12188856 | 6 | C | VINCRISTINE | VINCRISTINE | 1 | Unknown | UNK | U | 0 | |||||||||
| 121888562 | 12188856 | 7 | C | 6-MP | MERCAPTOPURINE | 1 | Oral | 50 MG, Q12H (X5 DAYS) 75 MGX 2 DAYS | 0 | 50 | MG | Q12H | |||||||
| 121888562 | 12188856 | 8 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Unknown | UNK | 0 | ||||||||||
| 121888562 | 12188856 | 9 | C | VORICONAZOLE. | VORICONAZOLE | 1 | Oral | 200 MG, Q12H | 19200 | MG | Y | 0 | 200 | MG | Q12H | ||||
| 121888562 | 12188856 | 10 | C | DESMOPRESSIN | DESMOPRESSIN | 1 | Nasal | 1 DF (1 SPRAY NASAL) | Y | 0 | 1 | DF | SPRAY | ||||||
| 121888562 | 12188856 | 11 | C | PENTAMIDINE ISETHIONATE | PENTAMIDINE ISETHIONATE | 1 | Respiratory (inhalation) | INH PO Q28D | 0 | ||||||||||
| 121888562 | 12188856 | 12 | C | OXYCODONE | OXYCODONE | 1 | Oral | 7.6 MG, Q4H (PRN) | 0 | 7.5 | MG | Q4H | |||||||
| 121888562 | 12188856 | 13 | C | OXYCODONE | OXYCODONE | 1 | 0 | ||||||||||||
| 121888562 | 12188856 | 14 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | 500 MG, QD | Y | 0 | 500 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121888562 | 12188856 | 1 | Acute lymphocytic leukaemia |
| 121888562 | 12188856 | 2 | Acute lymphocytic leukaemia |
| 121888562 | 12188856 | 3 | Acute lymphocytic leukaemia |
| 121888562 | 12188856 | 4 | Acute lymphocytic leukaemia |
| 121888562 | 12188856 | 5 | Product used for unknown indication |
| 121888562 | 12188856 | 6 | Product used for unknown indication |
| 121888562 | 12188856 | 7 | Chemotherapy |
| 121888562 | 12188856 | 8 | Prophylaxis |
| 121888562 | 12188856 | 9 | Prophylaxis |
| 121888562 | 12188856 | 10 | Von Willebrand's disease |
| 121888562 | 12188856 | 11 | Prophylaxis |
| 121888562 | 12188856 | 12 | Pain |
| 121888562 | 12188856 | 13 | Pain prophylaxis |
| 121888562 | 12188856 | 14 | Antibiotic prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121888562 | 12188856 | HO |
| 121888562 | 12188856 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121888562 | 12188856 | Colitis | |
| 121888562 | 12188856 | Cytokine release syndrome | |
| 121888562 | 12188856 | Febrile neutropenia | |
| 121888562 | 12188856 | Hypotension | |
| 121888562 | 12188856 | Hypoxia | |
| 121888562 | 12188856 | Infusion related reaction | |
| 121888562 | 12188856 | Staphylococcal bacteraemia | |
| 121888562 | 12188856 | Staphylococcal 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 |
|---|---|---|---|---|---|---|
| 121888562 | 12188856 | 1 | 20160223 | 20160223 | 0 | |
| 121888562 | 12188856 | 2 | 20160215 | 20160218 | 0 | |
| 121888562 | 12188856 | 3 | 20160215 | 20160216 | 0 | |
| 121888562 | 12188856 | 7 | 20160125 | 0 | ||
| 121888562 | 12188856 | 8 | 20160112 | 0 | ||
| 121888562 | 12188856 | 9 | 20160108 | 20160301 | 0 | |
| 121888562 | 12188856 | 10 | 20151113 | 20160224 | 0 | |
| 121888562 | 12188856 | 11 | 20160112 | 0 | ||
| 121888562 | 12188856 | 12 | 20160211 | 0 | ||
| 121888562 | 12188856 | 14 | 20160211 | 20160224 | 0 |