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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106697286 | 10669728 | 6 | F | 20131009 | 20160630 | 20141222 | 20160706 | EXP | CA-GSKJP-KK201404252GSK1550188002 | GLAXOSMITHKLINE | 38.30 | YR | F | Y | 76.00000 | KG | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106697286 | 10669728 | 1 | PS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 10 MG/KG ON WKS 0, 2, 4; THEN EVERY 4 WEEKS | Y | 71181B | 125370 | 700 | MG | ||||||
| 106697286 | 10669728 | 2 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 700 MG Q 4 WEEKS | Y | 125370 | 700 | MG | |||||||
| 106697286 | 10669728 | 3 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | UNK | Y | 125370 | |||||||||
| 106697286 | 10669728 | 4 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 1000 MG, Q4 WEEKS | Y | 125370 | 1000 | MG | |||||||
| 106697286 | 10669728 | 5 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 25 MG, U | U | 0 | 25 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 106697286 | 10669728 | 1 | Systemic lupus erythematosus |
| 106697286 | 10669728 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 106697286 | 10669728 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106697286 | 10669728 | Ankle fracture | |
| 106697286 | 10669728 | Arthralgia | |
| 106697286 | 10669728 | Arthropathy | |
| 106697286 | 10669728 | Chills | |
| 106697286 | 10669728 | Depressed mood | |
| 106697286 | 10669728 | Disability | |
| 106697286 | 10669728 | Drug ineffective | |
| 106697286 | 10669728 | Fatigue | |
| 106697286 | 10669728 | Headache | |
| 106697286 | 10669728 | Hyperhidrosis | |
| 106697286 | 10669728 | Hypersensitivity | |
| 106697286 | 10669728 | Malaise | |
| 106697286 | 10669728 | Mydriasis | |
| 106697286 | 10669728 | Nausea | |
| 106697286 | 10669728 | Oropharyngeal pain | |
| 106697286 | 10669728 | Pain | |
| 106697286 | 10669728 | Pyrexia | |
| 106697286 | 10669728 | Somnolence | |
| 106697286 | 10669728 | Systemic lupus erythematosus | |
| 106697286 | 10669728 | Tooth infection |
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 |
|---|---|---|---|---|---|---|
| 106697286 | 10669728 | 1 | 20130320 | 0 | ||
| 106697286 | 10669728 | 3 | 20141111 | 0 |