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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124945062 | 12494506 | 2 | F | 20160801 | 20160624 | 20160802 | EXP | FR-ROCHE-1780786 | ROCHE | 0.00 | M | Y | 0.00000 | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124945062 | 12494506 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 103705 | 800 | MG | SOLUTION FOR INFUSION | ||||||||
| 124945062 | 12494506 | 2 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | WEEK 1 | 103705 | 80 | MG | SOLUTION FOR INFUSION | |||||||
| 124945062 | 12494506 | 3 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | WEEK 2 | 103705 | 80 | MG | SOLUTION FOR INFUSION | |||||||
| 124945062 | 12494506 | 4 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | WEEK 3 | 103705 | 80 | MG | SOLUTION FOR INFUSION | |||||||
| 124945062 | 12494506 | 5 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | WEEK 4 | 103705 | 80 | MG | SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124945062 | 12494506 | 1 | Pulmonary fibrosis |
| 124945062 | 12494506 | 2 | Antineutrophil cytoplasmic antibody positive |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124945062 | 12494506 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124945062 | 12494506 | Acute hepatitis B | |
| 124945062 | 12494506 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 124945062 | 12494506 | 2 | 20151202 | 0 | ||
| 124945062 | 12494506 | 3 | 20151209 | 0 | ||
| 124945062 | 12494506 | 4 | 20151217 | 0 | ||
| 124945062 | 12494506 | 5 | 20151228 | 0 |