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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107538412 | 10753841 | 2 | F | 20131206 | 20160829 | 20150202 | 20160901 | EXP | FR-ROCHE-1350320 | ROCHE | GIRAUD C, TATAR Z AND SOUBRIER M AGRANULOCYTOSIS UNDER BIOTHERAPY IN RHEUMATOID ARTHRITIS: THREE CASES HYPOTHESIS OF PARVOVIRUS B19 INVOLVEMENT IN AGRANULOCYTOSIS OBSERVED UNDER TOCILIZUMAB AND RITUXIMAB FOR THE TREATMENT OF RHEUMATOID ARTHRITIS. CLINICAL RHEUMATOLOGY 2016 AUG 19;:1-4. | 53.00 | YR | F | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107538412 | 10753841 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | Y | 103705 | 1 | G | SOLUTION FOR INFUSION | QD | ||||||
| 107538412 | 10753841 | 2 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | Y | 103705 | 1 | G | SOLUTION FOR INFUSION | QD | ||||||
| 107538412 | 10753841 | 3 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | Y | 103705 | 1 | G | SOLUTION FOR INFUSION | QD | ||||||
| 107538412 | 10753841 | 4 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 4TH CYCLE | Y | 103705 | 1 | G | SOLUTION FOR INFUSION | QD | |||||
| 107538412 | 10753841 | 5 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | DAY 15 OF 4TH CYCLE | Y | 103705 | 1 | G | SOLUTION FOR INFUSION | QD | |||||
| 107538412 | 10753841 | 6 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | Y | 103705 | SOLUTION FOR INFUSION | |||||||||
| 107538412 | 10753841 | 7 | SS | Tocilizumab | TOCILIZUMAB | 1 | Unknown | 125276 | |||||||||||
| 107538412 | 10753841 | 8 | SS | METOJECT | METHOTREXATE SODIUM | 1 | Subcutaneous | Y | 0 | 15 | MG | QD | |||||||
| 107538412 | 10753841 | 9 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Oral | Y | 0 | 200 | MG | QD | |||||||
| 107538412 | 10753841 | 10 | C | LEVOTHYROX | LEVOTHYROXINE | 1 | Oral | 0 | |||||||||||
| 107538412 | 10753841 | 11 | C | SPECIAFOLDINE | FOLIC ACID | 1 | Oral | 0 | |||||||||||
| 107538412 | 10753841 | 12 | C | UVEDOSE | CHOLECALCIFEROL | 1 | Oral | TREATMENT DURATION = 1 DAY | 0 | ||||||||||
| 107538412 | 10753841 | 13 | C | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 0 | |||||||||||
| 107538412 | 10753841 | 14 | C | HUMIRA | ADALIMUMAB | 1 | Unknown | 0 | |||||||||||
| 107538412 | 10753841 | 15 | C | ENBREL | ETANERCEPT | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 107538412 | 10753841 | 1 | Rheumatoid arthritis |
| 107538412 | 10753841 | 7 | Rheumatoid arthritis |
| 107538412 | 10753841 | 8 | Rheumatoid arthritis |
| 107538412 | 10753841 | 9 | Rheumatoid arthritis |
| 107538412 | 10753841 | 10 | Hypothyroidism |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 107538412 | 10753841 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 107538412 | 10753841 | Agranulocytosis | |
| 107538412 | 10753841 | Leukopenia | |
| 107538412 | 10753841 | Thrombocytopenia | |
| 107538412 | 10753841 | Treatment failure |
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 |
|---|---|---|---|---|---|---|
| 107538412 | 10753841 | 1 | 201203 | 0 | ||
| 107538412 | 10753841 | 2 | 201210 | 0 | ||
| 107538412 | 10753841 | 3 | 201304 | 0 | ||
| 107538412 | 10753841 | 4 | 20131122 | 20131122 | 0 | |
| 107538412 | 10753841 | 5 | 20131206 | 20131206 | 0 | |
| 107538412 | 10753841 | 6 | 201211 | 0 | ||
| 107538412 | 10753841 | 7 | 2011 | 0 | ||
| 107538412 | 10753841 | 8 | 2005 | 20131206 | 0 | |
| 107538412 | 10753841 | 9 | 201302 | 20131206 | 0 | |
| 107538412 | 10753841 | 13 | 20131122 | 0 | ||
| 107538412 | 10753841 | 14 | 2005 | 2011 | 0 | |
| 107538412 | 10753841 | 15 | 2011 | 2012 | 0 |