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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121342746 | 12134274 | 6 | F | 201512 | 20160811 | 20160301 | 20160818 | EXP | CA-GLAXOSMITHKLINE-CA2015GSK164339 | GLAXOSMITHKLINE | 55.00 | YR | F | Y | 38.00000 | KG | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121342746 | 12134274 | 1 | PS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, UNK | 380123F, 381023F | 125370 | 600 | MG | |||||||
| 121342746 | 12134274 | 2 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, UNK | 381023F | 125370 | 600 | MG | |||||||
| 121342746 | 12134274 | 3 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, UNK | 125370 | 600 | MG | ||||||||
| 121342746 | 12134274 | 4 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 400 MG, UNK | 400613F | 125370 | 400 | MG | |||||||
| 121342746 | 12134274 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121342746 | 12134274 | 1 | Systemic lupus erythematosus |
| 121342746 | 12134274 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121342746 | 12134274 | HO |
| 121342746 | 12134274 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121342746 | 12134274 | Back pain | |
| 121342746 | 12134274 | Blister | |
| 121342746 | 12134274 | Dyspnoea | |
| 121342746 | 12134274 | Erythema | |
| 121342746 | 12134274 | Fall | |
| 121342746 | 12134274 | Feeding disorder | |
| 121342746 | 12134274 | Fracture | |
| 121342746 | 12134274 | Fractured coccyx | |
| 121342746 | 12134274 | Hip fracture | |
| 121342746 | 12134274 | Loss of consciousness | |
| 121342746 | 12134274 | Malaise | |
| 121342746 | 12134274 | Memory impairment | |
| 121342746 | 12134274 | Multiple fractures | |
| 121342746 | 12134274 | Neck pain | |
| 121342746 | 12134274 | Osteoporosis | |
| 121342746 | 12134274 | Pain | |
| 121342746 | 12134274 | Palliative care | |
| 121342746 | 12134274 | Pneumonia | |
| 121342746 | 12134274 | Rib fracture | |
| 121342746 | 12134274 | Scab | |
| 121342746 | 12134274 | Spinal compression fracture | |
| 121342746 | 12134274 | Systemic lupus erythematosus | |
| 121342746 | 12134274 | Thermal burn | |
| 121342746 | 12134274 | Urinary tract infection | |
| 121342746 | 12134274 | 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 |
|---|---|---|---|---|---|---|
| 121342746 | 12134274 | 1 | 20150527 | 0 | ||
| 121342746 | 12134274 | 2 | 20150527 | 0 | ||
| 121342746 | 12134274 | 3 | 20160209 | 0 | ||
| 121342746 | 12134274 | 4 | 20160714 | 0 |