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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93252188 | 9325218 | 8 | F | 2012 | 20160713 | 20130604 | 20160718 | EXP | CA-ROCHE-1231729 | ROCHE | 71.21 | YR | F | Y | 70.37000 | KG | 20160718 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93252188 | 9325218 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | DAE OF THE LAST DOSE OF RITUXIMAB PRIOR TO THE ADVERSE EVENT: 06/JUN/2012,16/MAY/2014 | H0793 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | ||||||
| 93252188 | 9325218 | 2 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | H0793 | 103705 | SOLUTION FOR INFUSION | |||||||||
| 93252188 | 9325218 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 0 | |||||||||||
| 93252188 | 9325218 | 4 | SS | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 0 | |||||||||||
| 93252188 | 9325218 | 5 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 93252188 | 9325218 | 6 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 93252188 | 9325218 | 7 | C | PANTOLOC | PANTOPRAZOLE SODIUM | 1 | Unknown | 0 | |||||||||||
| 93252188 | 9325218 | 8 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | 0 | ||||||||||||
| 93252188 | 9325218 | 9 | C | OXYCODONE | OXYCODONE | 1 | Unknown | AS REQUIRED | 0 | ||||||||||
| 93252188 | 9325218 | 10 | C | CELEBREX | CELECOXIB | 1 | 0 | ||||||||||||
| 93252188 | 9325218 | 11 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | |||||||||
| 93252188 | 9325218 | 12 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 93252188 | 9325218 | 1 | Rheumatoid arthritis |
| 93252188 | 9325218 | 3 | Product used for unknown indication |
| 93252188 | 9325218 | 4 | Product used for unknown indication |
| 93252188 | 9325218 | 5 | Premedication |
| 93252188 | 9325218 | 6 | Premedication |
| 93252188 | 9325218 | 11 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 93252188 | 9325218 | OT |
| 93252188 | 9325218 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 93252188 | 9325218 | Blood pressure diastolic decreased | |
| 93252188 | 9325218 | Bone disorder | |
| 93252188 | 9325218 | Dyspnoea | |
| 93252188 | 9325218 | Fall | |
| 93252188 | 9325218 | Gastric disorder | |
| 93252188 | 9325218 | Heart rate decreased | |
| 93252188 | 9325218 | Infusion related reaction | |
| 93252188 | 9325218 | Lower limb fracture | |
| 93252188 | 9325218 | Osteoarthritis | |
| 93252188 | 9325218 | Oxygen saturation decreased | |
| 93252188 | 9325218 | Pain | |
| 93252188 | 9325218 | Rheumatoid arthritis | |
| 93252188 | 9325218 | Stomatitis | |
| 93252188 | 9325218 | 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 |
|---|---|---|---|---|---|---|
| 93252188 | 9325218 | 1 | 20100212 | 0 | ||
| 93252188 | 9325218 | 2 | 20130625 | 0 | ||
| 93252188 | 9325218 | 3 | 201307 | 0 | ||
| 93252188 | 9325218 | 4 | 201307 | 0 | ||
| 93252188 | 9325218 | 5 | 20110615 | 0 | ||
| 93252188 | 9325218 | 6 | 20110615 | 0 | ||
| 93252188 | 9325218 | 7 | 201308 | 0 | ||
| 93252188 | 9325218 | 11 | 20110615 | 0 | ||
| 93252188 | 9325218 | 12 | 20130516 | 0 |