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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125558741 | 12555874 | 1 | I | 20160701 | 20160714 | 20160714 | EXP | DE-ACTAVIS-2016-14639 | WATSON | ZOELLNER AK, WEIGLEIN T, HUTTER G, ZIMMERMANN Y, CIEPLIK HC, HESS G + AL.. TEMSIROLIMUS ACTS AS ADDITIVE WITH BENDAMUSTINE IN AGGRESSIVE LYMPHOMA. ANN HEMATOL. 2016;95(3):403-7. | 65.00 | YR | M | Y | 0.00000 | 20160714 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125558741 | 12555874 | 1 | PS | Dexamethasone (Watson Laboratories) | DEXAMETHASONE | 1 | Unknown | UNK | UNCONFIRMED | 85456 | UNK | ||||||||
| 125558741 | 12555874 | 2 | SS | Carmustine (Unknown) | CARMUSTINE | 1 | Unknown | UNK | UNCONFIRMED | 0 | UNK | ||||||||
| 125558741 | 12555874 | 3 | SS | Cytarabine (Unknown) | CYTARABINE | 1 | Unknown | UNK | UNCONFIRMED | 0 | UNK | ||||||||
| 125558741 | 12555874 | 4 | SS | Etoposide (Unknown) | ETOPOSIDE | 1 | Unknown | UNK | UNCONFIRMED | 0 | UNK | ||||||||
| 125558741 | 12555874 | 5 | SS | MELPHALAN | MELPHALAN | 1 | Unknown | UNK | 0 | ||||||||||
| 125558741 | 12555874 | 6 | SS | Bendamustine (Unknown) | BENDAMUSTINE | 1 | Unknown | UNK | UNCONFIRMED | 0 | UNK | ||||||||
| 125558741 | 12555874 | 7 | SS | RITUXIMAB | RITUXIMAB | 1 | Unknown | 375 MG/M2, UNK | 0 | 375 | MG/M**2 | ||||||||
| 125558741 | 12555874 | 8 | SS | TEMSIROLIMUS | TEMSIROLIMUS | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125558741 | 12555874 | 1 | Mantle cell lymphoma |
| 125558741 | 12555874 | 2 | Mantle cell lymphoma |
| 125558741 | 12555874 | 3 | Mantle cell lymphoma |
| 125558741 | 12555874 | 4 | Mantle cell lymphoma |
| 125558741 | 12555874 | 5 | Mantle cell lymphoma |
| 125558741 | 12555874 | 6 | Mantle cell lymphoma |
| 125558741 | 12555874 | 7 | Mantle cell lymphoma |
| 125558741 | 12555874 | 8 | Mantle cell lymphoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125558741 | 12555874 | HO |
| 125558741 | 12555874 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125558741 | 12555874 | Leukopenia | |
| 125558741 | 12555874 | Necrotising fasciitis | |
| 125558741 | 12555874 | Pneumonia | |
| 125558741 | 12555874 | Sepsis | |
| 125558741 | 12555874 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |