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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108183929 | 10818392 | 9 | F | 201602 | 20160721 | 20150218 | 20160725 | EXP | CA-GSKJP-KK201405705GSK1550188SC003 | GLAXOSMITHKLINE | 35.62 | YR | F | Y | 68.00000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108183929 | 10818392 | 1 | PS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | EVERY 2 WEEKS FOR THE FIRST 3 INFUSIONS, THAN EVERY 4 WEEKS | U | 125370 | 650 | MG | |||||||
| 108183929 | 10818392 | 2 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 516 MG, Z | U | 125370 | 516 | MG | |||||||
| 108183929 | 10818392 | 3 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 630 MG, UNK | U | 125370 | 630 | MG | |||||||
| 108183929 | 10818392 | 4 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 630 MG, UNK | U | 381023F | 125370 | 630 | MG | ||||||
| 108183929 | 10818392 | 5 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 630 MG, UNK | U | 400613F | 125370 | 630 | MG | ||||||
| 108183929 | 10818392 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | UNK | U | 0 | ||||||||||
| 108183929 | 10818392 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | UNK | U | 0 | ||||||||||
| 108183929 | 10818392 | 8 | C | METHOTREXATE. | METHOTREXATE | 1 | UNK | U | 0 | ||||||||||
| 108183929 | 10818392 | 9 | C | CHLOROQUINE. | CHLOROQUINE | 1 | UNK | U | 0 | ||||||||||
| 108183929 | 10818392 | 10 | C | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | 500 MG, BID | 0 | 500 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108183929 | 10818392 | 1 | Systemic lupus erythematosus |
| 108183929 | 10818392 | 6 | Product used for unknown indication |
| 108183929 | 10818392 | 8 | Product used for unknown indication |
| 108183929 | 10818392 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108183929 | 10818392 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108183929 | 10818392 | Adverse event | |
| 108183929 | 10818392 | Alopecia | |
| 108183929 | 10818392 | Anaemia | |
| 108183929 | 10818392 | Crying | |
| 108183929 | 10818392 | Depression | |
| 108183929 | 10818392 | Fatigue | |
| 108183929 | 10818392 | Insomnia | |
| 108183929 | 10818392 | Lung disorder | |
| 108183929 | 10818392 | Nausea | |
| 108183929 | 10818392 | Underdose | |
| 108183929 | 10818392 | Urinary tract infection | |
| 108183929 | 10818392 | Weight decreased | |
| 108183929 | 10818392 | Weight increased | |
| 108183929 | 10818392 | Wound |
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 |
|---|---|---|---|---|---|---|
| 108183929 | 10818392 | 1 | 20120301 | 0 | ||
| 108183929 | 10818392 | 2 | 20120301 | 0 |