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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85804333 | 8580433 | 3 | F | 20120205 | 20160706 | 20120525 | 20160716 | EXP | FR-BAXTER-2012BAX006414 | BAXTER | 66.00 | YR | F | Y | 0.00000 | 20160716 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85804333 | 8580433 | 1 | PS | ENDOXAN 1000 MG, POUDRE POUR SOLUTION INJECTABLE | CYCLOPHOSPHAMIDE | 1 | Unknown | 1 DOSAGE FORMS | Y | 12142 | 25 | MG | POWDER FOR SOLUTION FOR INJECTION | /cycle | |||||
| 85804333 | 8580433 | 2 | SS | doxorubicin HCl | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | Y | 0 | 1 | DF | /cycle | |||||||
| 85804333 | 8580433 | 3 | SS | TORISEL | TEMSIROLIMUS | 1 | Unknown | Y | 0 | 25 | MG | /cycle | |||||||
| 85804333 | 8580433 | 4 | SS | TORISEL | TEMSIROLIMUS | 1 | Unknown | CYCLE 1, ARM A (R-CHOP-T), MOST RECENT DOSE BEFORE THE EVENTS ONSET | Y | 0 | 25 | MG | /cycle | ||||||
| 85804333 | 8580433 | 5 | SS | rituximab | RITUXIMAB | 1 | Unknown | Y | 0 | 1 | DF | /cycle | |||||||
| 85804333 | 8580433 | 6 | SS | VINCRISTINE SULFATE. | VINCRISTINE SULFATE | 1 | Unknown | Y | 0 | 1 | DF | /cycle | |||||||
| 85804333 | 8580433 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | Y | 0 | 1 | DF | /cycle |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 85804333 | 8580433 | 1 | Mantle cell lymphoma recurrent |
| 85804333 | 8580433 | 2 | Mantle cell lymphoma recurrent |
| 85804333 | 8580433 | 3 | Mantle cell lymphoma recurrent |
| 85804333 | 8580433 | 5 | Mantle cell lymphoma recurrent |
| 85804333 | 8580433 | 6 | Mantle cell lymphoma recurrent |
| 85804333 | 8580433 | 7 | Mantle cell lymphoma recurrent |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 85804333 | 8580433 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 85804333 | 8580433 | Febrile bone marrow aplasia | |
| 85804333 | 8580433 | Febrile neutropenia | |
| 85804333 | 8580433 | Gastric ulcer perforation | |
| 85804333 | 8580433 | Gastrointestinal haemorrhage | |
| 85804333 | 8580433 | Portal hypertension |
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 |
|---|---|---|---|---|---|---|
| 85804333 | 8580433 | 1 | 20120126 | 20120130 | 0 | |
| 85804333 | 8580433 | 2 | 20120126 | 20120130 | 0 | |
| 85804333 | 8580433 | 3 | 20120127 | 0 | ||
| 85804333 | 8580433 | 4 | 20120202 | 0 | ||
| 85804333 | 8580433 | 5 | 20120126 | 20120130 | 0 | |
| 85804333 | 8580433 | 6 | 20120126 | 20120130 | 0 | |
| 85804333 | 8580433 | 7 | 20120126 | 20120130 | 0 |