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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117847654 | 11784765 | 4 | F | 2013 | 20160707 | 20151130 | 20160711 | EXP | CA-ROCHE-1216062 | ROCHE | 58.45 | YR | M | Y | 68.00000 | KG | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117847654 | 11784765 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | LAST DOSE OF RITUXIMAB ON 07/DEC/2015 | B6223,B012,B62472 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | ||||||
| 117847654 | 11784765 | 2 | SS | RITUXAN | RITUXIMAB | 1 | B6223,B012,B62472 | 103705 | |||||||||||
| 117847654 | 11784765 | 3 | SS | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 117847654 | 11784765 | 4 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 117847654 | 11784765 | 5 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 117847654 | 11784765 | 6 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | |||||||||
| 117847654 | 11784765 | 7 | C | METHOTREXATE. | METHOTREXATE | 1 | 0 | ||||||||||||
| 117847654 | 11784765 | 8 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | 0 | ||||||||||||
| 117847654 | 11784765 | 9 | C | BACLOFEN. | BACLOFEN | 1 | 0 | ||||||||||||
| 117847654 | 11784765 | 10 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | ||||||||||||
| 117847654 | 11784765 | 11 | C | FENTANYL. | FENTANYL | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117847654 | 11784765 | 1 | Ankylosing spondylitis |
| 117847654 | 11784765 | 2 | Off label use |
| 117847654 | 11784765 | 3 | Product used for unknown indication |
| 117847654 | 11784765 | 4 | Premedication |
| 117847654 | 11784765 | 5 | Premedication |
| 117847654 | 11784765 | 6 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117847654 | 11784765 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117847654 | 11784765 | Back pain | |
| 117847654 | 11784765 | Blood pressure systolic increased | |
| 117847654 | 11784765 | Constipation | |
| 117847654 | 11784765 | Infusion related reaction | |
| 117847654 | 11784765 | Intestinal obstruction | |
| 117847654 | 11784765 | Nephrolithiasis | |
| 117847654 | 11784765 | Off label use | |
| 117847654 | 11784765 | Pain | |
| 117847654 | 11784765 | Weight fluctuation |
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 |
|---|---|---|---|---|---|---|
| 117847654 | 11784765 | 1 | 20121018 | 0 | ||
| 117847654 | 11784765 | 4 | 20121018 | 0 | ||
| 117847654 | 11784765 | 5 | 20121018 | 0 | ||
| 117847654 | 11784765 | 6 | 20121018 | 0 |