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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 95237334 | 9523733 | 4 | F | 20080926 | 20160627 | 20130914 | 20160704 | EXP | FR-ROCHE-1275724 | ROCHE | 70.36 | YR | F | Y | 69.00000 | KG | 20160704 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 95237334 | 9523733 | 1 | PS | RoActemra | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 40 INFUSION | 125276 | 8 | MG/KG | INFUSION | /month | ||||||
| 95237334 | 9523733 | 2 | SS | RoActemra | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 125276 | 550 | MG | |||||||||
| 95237334 | 9523733 | 3 | SS | RoActemra | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 125276 | 550 | MG | |||||||||
| 95237334 | 9523733 | 4 | SS | RoActemra | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 125276 | 550 | MG | |||||||||
| 95237334 | 9523733 | 5 | SS | RoActemra | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 125276 | 550 | MG | |||||||||
| 95237334 | 9523733 | 6 | SS | RoActemra | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 125276 | |||||||||||
| 95237334 | 9523733 | 7 | SS | CORTANCYL | PREDNISONE | 1 | Oral | 0 | 5 | MG | QD | ||||||||
| 95237334 | 9523733 | 8 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | D1 | 103705 | 1 | G | SOLUTION FOR INFUSION | |||||||
| 95237334 | 9523733 | 9 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | D15 | 103705 | 1 | G | SOLUTION FOR INFUSION | |||||||
| 95237334 | 9523733 | 10 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | D1 | 103705 | 1 | G | SOLUTION FOR INFUSION | |||||||
| 95237334 | 9523733 | 11 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | D15 | 103705 | 1 | G | SOLUTION FOR INFUSION | |||||||
| 95237334 | 9523733 | 12 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | D1 | 103705 | 1 | G | SOLUTION FOR INFUSION | |||||||
| 95237334 | 9523733 | 13 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | D15 | 103705 | 1 | G | SOLUTION FOR INFUSION | |||||||
| 95237334 | 9523733 | 14 | C | IMETH | METHOTREXATE SODIUM | 1 | Oral | 0 | 20 | MG | /wk | ||||||||
| 95237334 | 9523733 | 15 | C | APROVEL | IRBESARTAN | 1 | Unknown | 300 1 DOSE IN THE EVENING | 0 | ||||||||||
| 95237334 | 9523733 | 16 | C | DIFFU K | POTASSIUM CHLORIDE | 1 | Unknown | 1 DOSE IN THE MORNING | 0 | ||||||||||
| 95237334 | 9523733 | 17 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 10 1 DOSE IN THE EVENING | 0 | ||||||||||
| 95237334 | 9523733 | 18 | C | DAFALGAN | ACETAMINOPHEN | 1 | Unknown | 0 | 1 | G | BID | ||||||||
| 95237334 | 9523733 | 19 | C | FOSAVANCE | ALENDRONATE SODIUMCHOLECALCIFEROL | 1 | Unknown | 1/WEEK | 0 | ||||||||||
| 95237334 | 9523733 | 20 | C | XANAX | ALPRAZOLAM | 1 | Unknown | 0.50 1 DOSE IN THE EVENING | 0 | ||||||||||
| 95237334 | 9523733 | 21 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 20 MG/W STOPPED FROM 06/OCT/2010 TO 05/NOV/2010 | 0 | ||||||||||
| 95237334 | 9523733 | 22 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 0 | 100 | MG | |||||||||
| 95237334 | 9523733 | 23 | C | PARACETAMOL | ACETAMINOPHEN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 95237334 | 9523733 | 1 | Rheumatoid arthritis |
| 95237334 | 9523733 | 7 | Rheumatoid arthritis |
| 95237334 | 9523733 | 8 | Rheumatoid arthritis |
| 95237334 | 9523733 | 14 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 95237334 | 9523733 | HO |
| 95237334 | 9523733 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 95237334 | 9523733 | Aphthous ulcer | |
| 95237334 | 9523733 | Back pain | |
| 95237334 | 9523733 | Infusion related reaction | |
| 95237334 | 9523733 | Mouth ulceration | |
| 95237334 | 9523733 | Multiple organ dysfunction syndrome | |
| 95237334 | 9523733 | Neoplasm | |
| 95237334 | 9523733 | Noninfective gingivitis | |
| 95237334 | 9523733 | Perforation | |
| 95237334 | 9523733 | Peritonitis | |
| 95237334 | 9523733 | Septic shock |
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 |
|---|---|---|---|---|---|---|
| 95237334 | 9523733 | 1 | 20100410 | 0 | ||
| 95237334 | 9523733 | 2 | 20130401 | 0 | ||
| 95237334 | 9523733 | 3 | 20130513 | 0 | ||
| 95237334 | 9523733 | 4 | 20130610 | 0 | ||
| 95237334 | 9523733 | 5 | 20130708 | 20130708 | 0 | |
| 95237334 | 9523733 | 6 | 20100421 | 0 | ||
| 95237334 | 9523733 | 7 | 2007 | 20130731 | 0 | |
| 95237334 | 9523733 | 8 | 20080926 | 0 | ||
| 95237334 | 9523733 | 9 | 20081010 | 0 | ||
| 95237334 | 9523733 | 10 | 20090325 | 0 | ||
| 95237334 | 9523733 | 11 | 20090408 | 0 | ||
| 95237334 | 9523733 | 12 | 20091006 | 0 | ||
| 95237334 | 9523733 | 13 | 20091021 | 20100223 | 0 | |
| 95237334 | 9523733 | 14 | 2007 | 2013 | 0 |