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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116541994 | 11654199 | 4 | F | 201305 | 20160707 | 20151023 | 20160711 | EXP | CA-ROCHE-1137881 | ROCHE | 64.78 | YR | F | Y | 57.00000 | KG | 20160711 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116541994 | 11654199 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE OF RITUXIMAB: 24/JUL/2013.?LAST DOSE OF RITUXIMAB: 21/MAY/2014. | N34931,H06453 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | ||||||
| 116541994 | 11654199 | 2 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | N34931,H06453 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | |||||||
| 116541994 | 11654199 | 3 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 116541994 | 11654199 | 4 | C | METHOTREXATE. | METHOTREXATE | 1 | 0 | ||||||||||||
| 116541994 | 11654199 | 5 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 40 | MG | QD | ||||||||
| 116541994 | 11654199 | 6 | C | LOSEC | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 116541994 | 11654199 | 7 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | 0 | ||||||||||||
| 116541994 | 11654199 | 8 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | ||||||||||||
| 116541994 | 11654199 | 9 | C | EVENING PRIMROSE OIL | EVENING PRIMROSE OIL | 1 | 0 | ||||||||||||
| 116541994 | 11654199 | 10 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | |||||||||
| 116541994 | 11654199 | 11 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 116541994 | 11654199 | 12 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 116541994 | 11654199 | 13 | C | MILK THISTLE | MILK THISTLE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116541994 | 11654199 | 1 | Rheumatoid arthritis |
| 116541994 | 11654199 | 3 | Product used for unknown indication |
| 116541994 | 11654199 | 10 | Premedication |
| 116541994 | 11654199 | 11 | Premedication |
| 116541994 | 11654199 | 12 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116541994 | 11654199 | HO |
| 116541994 | 11654199 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116541994 | 11654199 | Abscess | |
| 116541994 | 11654199 | Anxiety | |
| 116541994 | 11654199 | Blood pressure fluctuation | |
| 116541994 | 11654199 | Burning sensation | |
| 116541994 | 11654199 | Deep vein thrombosis | |
| 116541994 | 11654199 | Diabetes mellitus | |
| 116541994 | 11654199 | Drug effect decreased | |
| 116541994 | 11654199 | Drug hypersensitivity | |
| 116541994 | 11654199 | Infusion related reaction | |
| 116541994 | 11654199 | Oxygen saturation decreased | |
| 116541994 | 11654199 | Vein disorder | |
| 116541994 | 11654199 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 116541994 | 11654199 | 1 | 20120718 | 0 | ||
| 116541994 | 11654199 | 2 | 20150305 | 0 | ||
| 116541994 | 11654199 | 10 | 20120718 | 0 | ||
| 116541994 | 11654199 | 11 | 20120718 | 0 | ||
| 116541994 | 11654199 | 12 | 20120718 | 0 |