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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127906141 | 12790614 | 1 | I | 20160205 | 20160208 | 20160929 | 20160929 | EXP | MX-ROCHE-1709617 | ROCHE | 47.98 | YR | F | Y | 70.00000 | KG | 20160929 | CN | MX | MX |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127906141 | 12790614 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | MOST RECENT DOSE IN FEB AND MAR/2016?EVERY ADMINISTRATION IS SEPERATED FOR 10 DAYS | U | 103705 | 500 | MG | SOLUTION FOR INFUSION | ||||||
| 127906141 | 12790614 | 2 | C | PREDNISONE. | PREDNISONE | 1 | Oral | CURRENTLY THIS TREATMENT IS ONGOING | 0 | 70 | MG | TABLET | QD | ||||||
| 127906141 | 12790614 | 3 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | CURRENTLY THIS TREATMENT IS ONGOING | 0 | 20 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127906141 | 12790614 | 1 | Vasculitis |
| 127906141 | 12790614 | 2 | Vasculitis |
| 127906141 | 12790614 | 3 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127906141 | 12790614 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127906141 | 12790614 | Cough | |
| 127906141 | 12790614 | Drug ineffective | |
| 127906141 | 12790614 | Headache | |
| 127906141 | 12790614 | Musculoskeletal pain | |
| 127906141 | 12790614 | Pulmonary fibrosis |
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 |
|---|---|---|---|---|---|---|
| 127906141 | 12790614 | 1 | 20160129 | 0 | ||
| 127906141 | 12790614 | 2 | 20160120 | 0 | ||
| 127906141 | 12790614 | 3 | 20160120 | 0 |