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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125112842 | 12511284 | 2 | F | 20160314 | 20160621 | 20160629 | 20160706 | EXP | FR-ASTRAZENECA-2016SE68874 | ASTRAZENECA | 24744.00 | DY | F | Y | 0.00000 | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125112842 | 12511284 | 1 | PS | INEXIUM | ESOMEPRAZOLE | 1 | Oral | U | 21153 | ||||||||||
| 125112842 | 12511284 | 2 | SS | CLAMOXYL | AMOXICILLINCLAVULANIC ACID | 1 | Oral | 0 | 500 | MG | BID | ||||||||
| 125112842 | 12511284 | 3 | SS | ZELITREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Oral | 28000 | MG | Y | 0 | 500 | MG | BID | |||||
| 125112842 | 12511284 | 4 | SS | TRIFLUCAN | FLUCONAZOLE | 1 | Oral | 8400 | MG | 0 | 400 | MG | QD | ||||||
| 125112842 | 12511284 | 5 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 3.0MG/KG UNKNOWN | 0 | 3 | MG/KG | ||||||||
| 125112842 | 12511284 | 6 | SS | ENDOXAN | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 2900 MG | 0 | ||||||||||
| 125112842 | 12511284 | 7 | SS | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 2 TABLETS | 0 | TABLET | |||||||||
| 125112842 | 12511284 | 8 | SS | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 0 | TABLET | ||||||||||
| 125112842 | 12511284 | 9 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Oral | 765 | MG/KG | U | 0 | 15 | MG/KG | TID | |||||
| 125112842 | 12511284 | 10 | SS | THIOTEPA. | THIOTEPA | 1 | Intravenous (not otherwise specified) | 500 | MG/KG | U | 0 | 100 | MG/KG | QD | |||||
| 125112842 | 12511284 | 11 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Oral | U | 0 | ||||||||||
| 125112842 | 12511284 | 12 | C | ARACYTINE | CYTARABINE | 1 | Unknown | 0 | |||||||||||
| 125112842 | 12511284 | 13 | C | ARACYTINE | CYTARABINE | 1 | Unknown | WITH RESCUE CHEMOTHERAPY AS ARACYTINE HIGH DOSE | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125112842 | 12511284 | 12 | Acute myeloid leukaemia |
| 125112842 | 12511284 | 13 | Acute myeloid leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125112842 | 12511284 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125112842 | 12511284 | Cerebral haemorrhage | |
| 125112842 | 12511284 | Graft complication | |
| 125112842 | 12511284 | Pyrexia | |
| 125112842 | 12511284 | Rash | |
| 125112842 | 12511284 | Retinal haemorrhage | |
| 125112842 | 12511284 | Sepsis | |
| 125112842 | 12511284 | Visual field defect |
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 |
|---|---|---|---|---|---|---|
| 125112842 | 12511284 | 2 | 201605 | 0 | ||
| 125112842 | 12511284 | 3 | 20160413 | 0 | ||
| 125112842 | 12511284 | 4 | 20160420 | 0 | ||
| 125112842 | 12511284 | 5 | 20160424 | 0 | ||
| 125112842 | 12511284 | 6 | 20160422 | 20160423 | 0 | |
| 125112842 | 12511284 | 7 | 201604 | 20160417 | 0 | |
| 125112842 | 12511284 | 9 | 20160424 | 0 | ||
| 125112842 | 12511284 | 10 | 20160413 | 20160417 | 0 | |
| 125112842 | 12511284 | 11 | 20160413 | 0 | ||
| 125112842 | 12511284 | 13 | 201512 | 0 |