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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117929985 | 11792998 | 5 | F | 20151120 | 20160822 | 20151202 | 20160823 | EXP | PHHO2015US019726 | SANDOZ | 6.18 | YR | M | Y | 17.90000 | KG | 20160824 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117929985 | 11792998 | 1 | SS | CTL019 | TISAGENLECLEUCEL-T | 1 | Intravenous (not otherwise specified) | TOTAL CELL DOSE: 0.3X10^9; TRANSDUCED T CELL DOSE: 3X10^6/KG | 0 | ||||||||||
| 117929985 | 11792998 | 2 | PS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 30 MG/M2 X 4 DAYS | 22137 | 30 | MG/M**2 | ||||||||
| 117929985 | 11792998 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 500 MG/M2 X 2 DAYS | 0 | 500 | MG/M**2 | ||||||||
| 117929985 | 11792998 | 4 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 41.6 MG, BID (Q SAT) | 3577.6001 | MG | Y | 0 | 41.6 | MG | BID | ||||
| 117929985 | 11792998 | 5 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Oral | 100 MG, QD | Y | 0 | 100 | MG | QD | ||||||
| 117929985 | 11792998 | 6 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | 165 MG, QD | 2970 | MG | Y | 0 | 165 | MG | QD | ||||
| 117929985 | 11792998 | 7 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 37.5 UG, QD | 0 | 37.5 | UG | QD | |||||||
| 117929985 | 11792998 | 8 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Oral | 100 MG, BID | 9400 | MG | Y | 0 | 100 | MG | BID | ||||
| 117929985 | 11792998 | 9 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Oral | 60 ML, TID | 456 | MG | Y | 0 | 60 | ML | TID | ||||
| 117929985 | 11792998 | 10 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Oral | 38 MG, TID | 456 | MG | Y | 0 | 38 | MG | TID | ||||
| 117929985 | 11792998 | 11 | C | IMMUNOGLOBULIN I.V | HUMAN IMMUNOGLOBULIN G | 1 | Unknown | UNK (MONTHLY/Q28 DAYS) | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117929985 | 11792998 | 1 | Acute lymphocytic leukaemia |
| 117929985 | 11792998 | 4 | Antifungal prophylaxis |
| 117929985 | 11792998 | 5 | Antifungal prophylaxis |
| 117929985 | 11792998 | 6 | Antibiotic prophylaxis |
| 117929985 | 11792998 | 7 | Hypothyroidism |
| 117929985 | 11792998 | 8 | Antiviral prophylaxis |
| 117929985 | 11792998 | 9 | Prophylaxis |
| 117929985 | 11792998 | 11 | Hypogammaglobulinaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117929985 | 11792998 | OT |
| 117929985 | 11792998 | LT |
| 117929985 | 11792998 | HO |
| 117929985 | 11792998 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117929985 | 11792998 | Abdominal compartment syndrome | |
| 117929985 | 11792998 | Acute kidney injury | |
| 117929985 | 11792998 | Cytokine release syndrome | |
| 117929985 | 11792998 | Disseminated intravascular coagulation | |
| 117929985 | 11792998 | Febrile neutropenia | |
| 117929985 | 11792998 | Haemorrhage intracranial | |
| 117929985 | 11792998 | Hypotension | |
| 117929985 | 11792998 | Hypoxia |
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 |
|---|---|---|---|---|---|---|
| 117929985 | 11792998 | 1 | 20151117 | 20151117 | 0 | |
| 117929985 | 11792998 | 2 | 20151109 | 20151112 | 0 | |
| 117929985 | 11792998 | 3 | 20151109 | 20151110 | 0 | |
| 117929985 | 11792998 | 4 | 20151010 | 20151121 | 0 | |
| 117929985 | 11792998 | 5 | 20151118 | 20151121 | 0 | |
| 117929985 | 11792998 | 6 | 20151103 | 20151120 | 0 | |
| 117929985 | 11792998 | 7 | 20151007 | 0 | ||
| 117929985 | 11792998 | 8 | 20151006 | 20151121 | 0 | |
| 117929985 | 11792998 | 9 | 20151110 | 0 | ||
| 117929985 | 11792998 | 10 | 20151126 | 20151201 | 0 | |
| 117929985 | 11792998 | 11 | 20151009 | 0 |