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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105030509 | 10503050 | 9 | F | 201409 | 20160826 | 20141007 | 20160830 | EXP | CA-GSKJP-KK201401587GSK1550188SC003 | GLAXOSMITHKLINE | 39.92 | YR | M | Y | 89.40000 | KG | 20160830 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105030509 | 10503050 | 1 | PS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 890 MG, 0,2,4 WEEKS THEN EVERY 4 WEEKS | U | 125370 | POWDER FOR INFUSION | ||||||||
| 105030509 | 10503050 | 2 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 890 MG, UNK | U | 400613F | 125370 | 890 | MG | POWDER FOR INFUSION | |||||
| 105030509 | 10503050 | 3 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 890 MG, UNK | U | 381023F | 125370 | 890 | MG | POWDER FOR INFUSION | |||||
| 105030509 | 10503050 | 4 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 890 MG, UNK | U | 125370 | 890 | MG | POWDER FOR INFUSION | ||||||
| 105030509 | 10503050 | 5 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 890 MG, UNK | U | 125370 | 890 | MG | POWDER FOR INFUSION | ||||||
| 105030509 | 10503050 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK UNK, U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 105030509 | 10503050 | 1 | Systemic lupus erythematosus |
| 105030509 | 10503050 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 105030509 | 10503050 | OT |
| 105030509 | 10503050 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 105030509 | 10503050 | Abnormal faeces | |
| 105030509 | 10503050 | Arthralgia | |
| 105030509 | 10503050 | Arthritis | |
| 105030509 | 10503050 | Clostridium difficile infection | |
| 105030509 | 10503050 | Diarrhoea | |
| 105030509 | 10503050 | Fatigue | |
| 105030509 | 10503050 | Myalgia | |
| 105030509 | 10503050 | Nausea | |
| 105030509 | 10503050 | Osteonecrosis | |
| 105030509 | 10503050 | Pericarditis | |
| 105030509 | 10503050 | Therapeutic response unexpected | |
| 105030509 | 10503050 | Tooth infection | |
| 105030509 | 10503050 | Upper respiratory tract infection | |
| 105030509 | 10503050 | Vomiting | |
| 105030509 | 10503050 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 105030509 | 10503050 | 1 | 20120302 | 0 | ||
| 105030509 | 10503050 | 4 | 20150123 | 0 |