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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126539311 | 12653931 | 1 | I | 20100928 | 20160812 | 20160816 | 20160816 | EXP | US-ROCHE-1813466 | ROCHE | 51.00 | YR | M | Y | 0.00000 | 20160816 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126539311 | 12653931 | 1 | PS | Rituximab | RITUXIMAB | 1 | Intravenous (not otherwise specified) | MOST RECENT PROTOCOL TREATMENT DATE PRIOR TO SAE : 23/SEP/2010 | 103705 | SOLUTION FOR INFUSION | |||||||||
| 126539311 | 12653931 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | MOST RECENT PROTOCOL TRETRMENT DATE PRIOR TO SAE : 23/SEP/2010 | 0 | ||||||||||
| 126539311 | 12653931 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | MOST RECENT PROTOCOL TRETRMENT DATE PRIOR TO SAE : 23/SEP/2010 | 0 | ||||||||||
| 126539311 | 12653931 | 4 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | MOST RECENT PROTOCOL TRETRMENT DATE PRIOR TO SAE : 23/SEP/2010 | 0 | ||||||||||
| 126539311 | 12653931 | 5 | C | ETANERCEPT | ETANERCEPT | 1 | Unknown | 0 | |||||||||||
| 126539311 | 12653931 | 6 | C | METHYLPREDNISONE (UNK INGREDIENTS) | 2 | Unknown | 0 | ||||||||||||
| 126539311 | 12653931 | 7 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 0 | |||||||||||
| 126539311 | 12653931 | 8 | C | OCTREOTIDE ACETATE. | OCTREOTIDE ACETATE | 1 | Unknown | 0 | |||||||||||
| 126539311 | 12653931 | 9 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126539311 | 12653931 | 1 | B-cell lymphoma |
| 126539311 | 12653931 | 2 | B-cell lymphoma |
| 126539311 | 12653931 | 3 | B-cell lymphoma |
| 126539311 | 12653931 | 4 | B-cell lymphoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126539311 | 12653931 | HO |
| 126539311 | 12653931 | DE |
| 126539311 | 12653931 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126539311 | 12653931 | Diarrhoea | |
| 126539311 | 12653931 | Febrile neutropenia | |
| 126539311 | 12653931 | Pyrexia | |
| 126539311 | 12653931 | Restrictive cardiomyopathy |
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 |
|---|---|---|---|---|---|---|
| 126539311 | 12653931 | 1 | 20100819 | 0 | ||
| 126539311 | 12653931 | 2 | 20100819 | 0 | ||
| 126539311 | 12653931 | 3 | 20100819 | 0 | ||
| 126539311 | 12653931 | 4 | 20100819 | 0 | ||
| 126539311 | 12653931 | 5 | 20101120 | 0 | ||
| 126539311 | 12653931 | 6 | 20101112 | 0 | ||
| 126539311 | 12653931 | 7 | 20101115 | 20101126 | 0 | |
| 126539311 | 12653931 | 8 | 20101116 | 20101128 | 0 | |
| 126539311 | 12653931 | 9 | 20101109 | 20101112 | 0 |