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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126299752 | 12629975 | 2 | F | 20160630 | 20160829 | 20160808 | 20160830 | EXP | PL-TEVA-681331ISR | TEVA | 6.00 | YR | F | Y | 20.00000 | KG | 20160830 | MD | PL | PL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126299752 | 12629975 | 1 | PS | Tbo-filgrastim | TBO-FILGRASTIM | 1 | Subcutaneous | DATE OF LAST DOSE PRIOR TO SAE: 14-MAY-2016 | NAV | 0 | |||||||||
| 126299752 | 12629975 | 2 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 2.48 GRAM DAILY; DATE OF LAST DOSE PRIOR TO SAE: 25-JUN-2016 | 0 | 2.48 | G | QD | |||||||
| 126299752 | 12629975 | 3 | SS | ADRIAMYCIN | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 16.5 MILLIGRAM DAILY; DATE OF LAST DOSE PRIOR TO SAE: 25-JUN-2016 | 0 | 16.5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126299752 | 12629975 | 1 | Neutropenia |
| 126299752 | 12629975 | 2 | Ewing's sarcoma |
| 126299752 | 12629975 | 3 | Ewing's sarcoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126299752 | 12629975 | OT |
| 126299752 | 12629975 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126299752 | 12629975 | Bone marrow failure | |
| 126299752 | 12629975 | Febrile neutropenia | |
| 126299752 | 12629975 | Haematemesis |
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 |
|---|---|---|---|---|---|---|
| 126299752 | 12629975 | 1 | 20160505 | 0 | ||
| 126299752 | 12629975 | 2 | 20160623 | 0 | ||
| 126299752 | 12629975 | 3 | 20160623 | 0 |