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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1021940911 | 10219409 | 11 | F | 20140523 | 20160719 | 20140605 | 20160721 | EXP | CA-GLAXOSMITHKLINE-A1072352A | GLAXOSMITHKLINE | 60.99 | YR | F | Y | 94.00000 | KG | 20160721 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1021940911 | 10219409 | 1 | PS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | WEEKLY INFUSION AT WEEK 0, 2, 4 AND THEN EVERY 4 WEEKS | U | UNKNOWN | 125370 | 850 | MG | ||||||
| 1021940911 | 10219409 | 2 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, UNK | U | 400613F | 125370 | 900 | MG | ||||||
| 1021940911 | 10219409 | 3 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, UNK | U | 381023F | 125370 | 900 | MG | ||||||
| 1021940911 | 10219409 | 4 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, UNK | U | 125370 | 900 | MG | |||||||
| 1021940911 | 10219409 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 2.5 MG, 1D | U | 0 | 2.5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1021940911 | 10219409 | 1 | Systemic lupus erythematosus |
| 1021940911 | 10219409 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1021940911 | 10219409 | DS |
| 1021940911 | 10219409 | OT |
| 1021940911 | 10219409 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1021940911 | 10219409 | Blood insulin abnormal | |
| 1021940911 | 10219409 | Cellulitis | |
| 1021940911 | 10219409 | Chronic obstructive pulmonary disease | |
| 1021940911 | 10219409 | Contusion | |
| 1021940911 | 10219409 | Dehydration | |
| 1021940911 | 10219409 | Disability | |
| 1021940911 | 10219409 | Fall | |
| 1021940911 | 10219409 | Fatigue | |
| 1021940911 | 10219409 | Gait disturbance | |
| 1021940911 | 10219409 | Hospitalisation | |
| 1021940911 | 10219409 | Ill-defined disorder | |
| 1021940911 | 10219409 | Laceration | |
| 1021940911 | 10219409 | Neck pain | |
| 1021940911 | 10219409 | Necrotising fasciitis | |
| 1021940911 | 10219409 | Systemic lupus erythematosus |
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 |
|---|---|---|---|---|---|---|
| 1021940911 | 10219409 | 1 | 20140401 | 0 | ||
| 1021940911 | 10219409 | 5 | 20140401 | 0 |