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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122826912 | 12282691 | 2 | F | 20160402 | 20160815 | 20160419 | 20160829 | EXP | DE-TEVA-653070ISR | TEVA | 63.25 | YR | F | Y | 74.20000 | KG | 20160829 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122826912 | 12282691 | 1 | PS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | 53 MILLIGRAM DAILY; | 76349 | 53 | MG | QD | |||||||
| 122826912 | 12282691 | 2 | SS | THIOTEPA. | THIOTEPA | 1 | Unknown | 335 MILLIGRAM DAILY; | 0 | 335 | MG | QD | |||||||
| 122826912 | 12282691 | 3 | SS | Treosulfan | TREOSULFAN | 1 | Unknown | 21.1 MILLIGRAM DAILY; | 0 | 21.1 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122826912 | 12282691 | 1 | Bone marrow conditioning regimen |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122826912 | 12282691 | LT |
| 122826912 | 12282691 | HO |
| 122826912 | 12282691 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122826912 | 12282691 | Acute kidney injury | |
| 122826912 | 12282691 | Hepatic failure | |
| 122826912 | 12282691 | Hepatotoxicity | |
| 122826912 | 12282691 | Ileus paralytic | |
| 122826912 | 12282691 | Mucosal inflammation | |
| 122826912 | 12282691 | Neutropenic colitis | |
| 122826912 | 12282691 | Organic brain syndrome | |
| 122826912 | 12282691 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 122826912 | 12282691 | 1 | 20160324 | 20160326 | 0 | |
| 122826912 | 12282691 | 2 | 20160324 | 20160326 | 0 | |
| 122826912 | 12282691 | 3 | 20160327 | 20160329 | 0 |