Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5797498 | 6695425 | I | 5797498-3 | 20080608 | 20080617 | 20080630 | EXP | 2008-02187 | MILLENNIUM PHARMACEUTICALS INC. | 59 | YR | M | N | 67.2 | KG | 20080625 | MD | UNITED STATES |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 5797498 | 1010120677 | PS | VELCADE | 1 | INTRAVENOUS BOLUS | 1.3 MG/M2, IV BOLUS | U | U | 21602 | ||
| 5797498 | 1010152790 | SS | RITUXIMAB(RITUXIMAB) INJECTION, 375MG/M2 | 2 | INTRAVENOUS | 375 MG/M2 , INTRAVENOUS | U | U | |||
| 5797498 | 1010152791 | SS | CYCLOPHOSPHAMIDE | 1 | INTRAVENOUS | 300 MG/M2, INTRAVENOUS | U | U | |||
| 5797498 | 1010152792 | SS | DOXORUBICIN HCL | 1 | INTRAVENOUS | 25 MG/M2, INTRAVENOUS | U | U | |||
| 5797498 | 1010152793 | SS | VINCRISTINE | 1 | INTRAVENOUS BOLUS | 1 MG, IV BOLUS | U | U | |||
| 5797498 | 1010152794 | SS | DEXAMETHASONE TAB | 1 | 40 MG | U | U | ||||
| 5797498 | 1010152796 | SS | NEULASTA | 1 | U | U | |||||
| 5797498 | 1010152797 | SS | G-CSF(G-CSF) INJECTION | 2 | U | U |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 5797498 | 1010120677 | MANTLE CELL LYMPHOMA |
| 5797498 | 1010152790 | MANTLE CELL LYMPHOMA |
| 5797498 | 1010152791 | MANTLE CELL LYMPHOMA |
| 5797498 | 1010152792 | MANTLE CELL LYMPHOMA |
| 5797498 | 1010152793 | MANTLE CELL LYMPHOMA |
| 5797498 | 1010152794 | MANTLE CELL LYMPHOMA |
| 5797498 | 1010152796 | MANTLE CELL LYMPHOMA |
| 5797498 | 1010152797 | MANTLE CELL LYMPHOMA |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 5797498 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 5797498 | BODY TEMPERATURE INCREASED |
| 5797498 | HAEMOGLOBIN DECREASED |
| 5797498 | HYPOALBUMINAEMIA |
| 5797498 | HYPOCALCAEMIA |
| 5797498 | LYMPHOPENIA |
| 5797498 | NEUTROPHIL COUNT DECREASED |
| 5797498 | PLATELET COUNT DECREASED |
| 5797498 | WHITE BLOOD CELL COUNT DECREASED |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | RPSR COD |
|---|---|
| 5797498 | HP |
| 5797498 | SDY |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 5797498 | 1010120677 | 20080529 | 20080601 | ||
| 5797498 | 1010152790 | 20080529 | |||
| 5797498 | 1010152791 | 20080529 | |||
| 5797498 | 1010152792 | 20080529 | |||
| 5797498 | 1010152793 | 20080529 | |||
| 5797498 | 1010152794 | 20080529 | |||
| 5797498 | 1010152796 | 20080529 | |||
| 5797498 | 1010152797 | 20080529 |