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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107524533 | 10752453 | 3 | F | 201309 | 20160726 | 20150130 | 20160812 | EXP | US-GLAXOSMITHKLINE-US2014036369 | GLAXOSMITHKLINE | 43.80 | YR | F | Y | 0.00000 | 20160812 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107524533 | 10752453 | 1 | PS | BENLYSTA | BELIMUMAB | 1 | Intravenous drip | 600 MG, CYC | U | 125370 | 600 | MG | POWDER FOR INFUSION | ||||||
| 107524533 | 10752453 | 2 | SS | BENLYSTA | BELIMUMAB | 1 | UNK | U | UNKNOWN | 125370 | POWDER FOR INFUSION | ||||||||
| 107524533 | 10752453 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Y | UNKNOWN | 0 | ||||||||||
| 107524533 | 10752453 | 4 | C | ACTHAR | CORTICOTROPIN | 1 | U | 0 | |||||||||||
| 107524533 | 10752453 | 5 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | U | 0 | |||||||||||
| 107524533 | 10752453 | 6 | C | PREDNISONE. | PREDNISONE | 1 | U | 0 | |||||||||||
| 107524533 | 10752453 | 7 | C | TORADOL | KETOROLAC TROMETHAMINE | 1 | U | 0 | |||||||||||
| 107524533 | 10752453 | 8 | C | TREXIMET | NAPROXEN SODIUMSUMATRIPTAN SUCCINATE | 1 | U | 0 | |||||||||||
| 107524533 | 10752453 | 9 | C | EVOXAC | CEVIMELINE HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 107524533 | 10752453 | 1 | Systemic lupus erythematosus |
| 107524533 | 10752453 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 107524533 | 10752453 | Abdominal discomfort | |
| 107524533 | 10752453 | Dizziness | |
| 107524533 | 10752453 | Drug dose omission | |
| 107524533 | 10752453 | Fatigue | |
| 107524533 | 10752453 | Headache | |
| 107524533 | 10752453 | Hepatic enzyme increased | |
| 107524533 | 10752453 | Malaise | |
| 107524533 | 10752453 | Rash | |
| 107524533 | 10752453 | Stress | |
| 107524533 | 10752453 | Tongue discolouration |
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 |
|---|---|---|---|---|---|---|
| 107524533 | 10752453 | 1 | 201309 | 0 | ||
| 107524533 | 10752453 | 2 | 20141001 | 0 |