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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127538291 | 12753829 | 1 | I | 20070321 | 20071018 | 20160916 | 20160916 | EXP | DE-ROCHE-GNE250459 | ROCHE | 78.14 | YR | F | Y | 76.08000 | KG | 20160916 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127538291 | 12753829 | 1 | PS | Rituximab | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 880 MG, UNK | NOT REPORTED | 103705 | 880 | MG | SOLUTION FOR INFUSION | ||||||
| 127538291 | 12753829 | 2 | SS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 35 MG, UNK | 0 | 35 | MG | ||||||||
| 127538291 | 12753829 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 350 MG, UNK | 0 | 350 | MG | ||||||||
| 127538291 | 12753829 | 4 | SS | MESNA. | MESNA | 1 | Intravenous (not otherwise specified) | 100 MG, UNK | 0 | 100 | MG | ||||||||
| 127538291 | 12753829 | 5 | SS | Pegfilgrastim | PEGFILGRASTIM | 1 | Subcutaneous | 6 MG, UNK | 0 | 6 | MG | ||||||||
| 127538291 | 12753829 | 6 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 8 MG, UNK | 0 | 8 | MG | ||||||||
| 127538291 | 12753829 | 7 | C | Kevatril | GRANISETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 3 MG, UNK | 0 | 3 | MG | ||||||||
| 127538291 | 12753829 | 8 | C | TAVEGIL | CLEMASTINE FUMARATE | 1 | Intravenous (not otherwise specified) | 1 AMP, UNK, DOSE=1 AMP | 0 | ||||||||||
| 127538291 | 12753829 | 9 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 1000 MG, UNK | 0 | 1000 | MG | ||||||||
| 127538291 | 12753829 | 10 | C | PREDNISOLUT | PREDNISOLONE | 1 | Intravenous (not otherwise specified) | 100 MG, UNK | 0 | 100 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127538291 | 12753829 | 1 | Chronic lymphocytic leukaemia |
| 127538291 | 12753829 | 2 | Chronic lymphocytic leukaemia |
| 127538291 | 12753829 | 3 | Chronic lymphocytic leukaemia |
| 127538291 | 12753829 | 4 | Product used for unknown indication |
| 127538291 | 12753829 | 5 | Product used for unknown indication |
| 127538291 | 12753829 | 6 | Product used for unknown indication |
| 127538291 | 12753829 | 7 | Product used for unknown indication |
| 127538291 | 12753829 | 8 | Product used for unknown indication |
| 127538291 | 12753829 | 9 | Product used for unknown indication |
| 127538291 | 12753829 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127538291 | 12753829 | HO |
| 127538291 | 12753829 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127538291 | 12753829 | Diverticulum intestinal | |
| 127538291 | 12753829 | Gastritis |
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 |
|---|---|---|---|---|---|---|
| 127538291 | 12753829 | 1 | 20060828 | 20070213 | 0 | |
| 127538291 | 12753829 | 2 | 20060828 | 20070213 | 0 | |
| 127538291 | 12753829 | 3 | 20060828 | 20070213 | 0 | |
| 127538291 | 12753829 | 4 | 20060828 | 20070213 | 0 | |
| 127538291 | 12753829 | 5 | 20061013 | 20070213 | 0 | |
| 127538291 | 12753829 | 6 | 20060828 | 20070213 | 0 | |
| 127538291 | 12753829 | 7 | 20060828 | 20070213 | 0 | |
| 127538291 | 12753829 | 8 | 20060828 | 20070213 | 0 | |
| 127538291 | 12753829 | 9 | 20060828 | 20070213 | 0 | |
| 127538291 | 12753829 | 10 | 20060828 | 20070213 | 0 |