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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1046054811 | 10460548 | 11 | F | 201309 | 20160901 | 20140918 | 20160906 | EXP | CA-ROCHE-1305859 | ROCHE | 33.37 | YR | F | Y | 80.00000 | KG | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1046054811 | 10460548 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | DATE OF MOST RECENT DOSE PRIOR TO SAE: 03/APR/2013, 09/OCT/2013, 07/JUL/2015 AND 21/JUL/2015 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | |||||||
| 1046054811 | 10460548 | 2 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 103705 | SOLUTION FOR INFUSION | ||||||||||
| 1046054811 | 10460548 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | N | 0 | ||||||||||
| 1046054811 | 10460548 | 4 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 1046054811 | 10460548 | 5 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 100 | MG | |||||||||
| 1046054811 | 10460548 | 6 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 1046054811 | 10460548 | 7 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 1046054811 | 10460548 | 8 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | |||||||||
| 1046054811 | 10460548 | 9 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 250 | MG | |||||||||
| 1046054811 | 10460548 | 10 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | |||||||||
| 1046054811 | 10460548 | 11 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | 0 | ||||||||||||
| 1046054811 | 10460548 | 12 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 1046054811 | 10460548 | 13 | C | MICARDIS | TELMISARTAN | 1 | 0 | ||||||||||||
| 1046054811 | 10460548 | 14 | C | HYDROMORPH CONTIN | HYDROMORPHONE | 1 | 0 | ||||||||||||
| 1046054811 | 10460548 | 15 | C | ATORVASTATIN | ATORVASTATIN | 1 | 0 | ||||||||||||
| 1046054811 | 10460548 | 16 | C | ADVIL | IBUPROFEN | 1 | Unknown | AS REQUIRED | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1046054811 | 10460548 | 1 | Rheumatoid arthritis |
| 1046054811 | 10460548 | 3 | Product used for unknown indication |
| 1046054811 | 10460548 | 4 | Premedication |
| 1046054811 | 10460548 | 7 | Premedication |
| 1046054811 | 10460548 | 8 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1046054811 | 10460548 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1046054811 | 10460548 | Arthralgia | |
| 1046054811 | 10460548 | Back pain | |
| 1046054811 | 10460548 | Blood cholesterol increased | |
| 1046054811 | 10460548 | Blood pressure increased | |
| 1046054811 | 10460548 | Device dislocation | |
| 1046054811 | 10460548 | Drug ineffective | |
| 1046054811 | 10460548 | Heart rate increased | |
| 1046054811 | 10460548 | Hypersensitivity | |
| 1046054811 | 10460548 | Infusion related reaction | |
| 1046054811 | 10460548 | Iron deficiency | |
| 1046054811 | 10460548 | Musculoskeletal pain | |
| 1046054811 | 10460548 | Oligomenorrhoea | |
| 1046054811 | 10460548 | Precancerous cells present | |
| 1046054811 | 10460548 | Rheumatoid arthritis | |
| 1046054811 | 10460548 | Type 2 diabetes mellitus | |
| 1046054811 | 10460548 | Uterine leiomyoma | |
| 1046054811 | 10460548 | Weight decreased | |
| 1046054811 | 10460548 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 1046054811 | 10460548 | 1 | 20120718 | 0 | ||
| 1046054811 | 10460548 | 2 | 20131211 | 0 | ||
| 1046054811 | 10460548 | 3 | 201406 | 0 | ||
| 1046054811 | 10460548 | 4 | 20120718 | 20130320 | 0 | |
| 1046054811 | 10460548 | 5 | 20130403 | 20130403 | 0 | |
| 1046054811 | 10460548 | 6 | 20131128 | 20150721 | 0 | |
| 1046054811 | 10460548 | 7 | 20120718 | 20150721 | 0 | |
| 1046054811 | 10460548 | 8 | 20120718 | 20120718 | 0 | |
| 1046054811 | 10460548 | 9 | 20120904 | 20120919 | 0 | |
| 1046054811 | 10460548 | 10 | 20130320 | 20150721 | 0 |