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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105708957 | 10570895 | 7 | F | 20121221 | 20160712 | 20141107 | 20160718 | EXP | CA-GSKJP-KK201310284GSK1550188002 | GLAXOSMITHKLINE | 39.74 | YR | F | Y | 86.00000 | KG | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105708957 | 10570895 | 1 | PS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | 860 MG WKS 0, 2, 4 THEN EVERY 4 WEEKS | U | 71175A | 125370 | 860 | MG | ||||||
| 105708957 | 10570895 | 2 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | UNK | U | 71181D | 125370 | ||||||||
| 105708957 | 10570895 | 3 | SS | BENLYSTA | BELIMUMAB | 1 | Intravenous (not otherwise specified) | UNK | U | 71191A | 125370 | ||||||||
| 105708957 | 10570895 | 4 | SS | BENLYSTA | BELIMUMAB | 1 | UNK | U | 71190A | 125370 | |||||||||
| 105708957 | 10570895 | 5 | SS | BENLYSTA | BELIMUMAB | 1 | 750 MG, CYC | U | 71181A | 125370 | 750 | MG | |||||||
| 105708957 | 10570895 | 6 | SS | BENLYSTA | BELIMUMAB | 1 | 720 MG, UNK | U | 71190A | 125370 | 720 | MG | |||||||
| 105708957 | 10570895 | 7 | SS | BENLYSTA | BELIMUMAB | 1 | 650 UNK, Q4 WEEKS | U | 125370 | 650 | MG | ||||||||
| 105708957 | 10570895 | 8 | SS | BENLYSTA | BELIMUMAB | 1 | 720 MG, UNK | U | 4006L3F | 125370 | 720 | MG | |||||||
| 105708957 | 10570895 | 9 | SS | BENLYSTA | BELIMUMAB | 1 | 720 UNK, UNK | U | 381023F | 125370 | 720 | MG | |||||||
| 105708957 | 10570895 | 10 | SS | BENLYSTA | BELIMUMAB | 1 | 650 MG, UNK | U | 125370 | 650 | MG | ||||||||
| 105708957 | 10570895 | 11 | SS | Amitriptyline | AMITRIPTYLINE | 1 | UNK | U | 0 | ||||||||||
| 105708957 | 10570895 | 12 | C | GRAVOL | DIMENHYDRINATE | 1 | Intravenous (not otherwise specified) | 50 MG, UNK | U | 0 | 50 | MG | |||||||
| 105708957 | 10570895 | 13 | C | TYLENOL | ACETAMINOPHEN | 1 | 650 MG, UNK | U | 0 | 650 | MG | ||||||||
| 105708957 | 10570895 | 14 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 15 MG, 1D | U | 0 | 15 | MG | QD | ||||||
| 105708957 | 10570895 | 15 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | 400 MG, UNK | U | 0 | 400 | MG | ||||||||
| 105708957 | 10570895 | 16 | C | FENTANYL TRANSDERMAL SYSTEM | FENTANYL | 1 | 25 MG EVERY TWO DAYS | U | 0 | 25 | MG | ||||||||
| 105708957 | 10570895 | 17 | C | SINEMET | CARBIDOPALEVODOPA | 1 | Oral | 4 MG, 1D | U | 0 | 4 | MG | QD | ||||||
| 105708957 | 10570895 | 18 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 105708957 | 10570895 | 1 | Systemic lupus erythematosus |
| 105708957 | 10570895 | 11 | Product used for unknown indication |
| 105708957 | 10570895 | 12 | Product used for unknown indication |
| 105708957 | 10570895 | 13 | Product used for unknown indication |
| 105708957 | 10570895 | 14 | Product used for unknown indication |
| 105708957 | 10570895 | 15 | Product used for unknown indication |
| 105708957 | 10570895 | 16 | Product used for unknown indication |
| 105708957 | 10570895 | 17 | Product used for unknown indication |
| 105708957 | 10570895 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 105708957 | 10570895 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 105708957 | 10570895 | Catheter site discharge | |
| 105708957 | 10570895 | Cholecystectomy | |
| 105708957 | 10570895 | Cholelithiasis | |
| 105708957 | 10570895 | Erythema multiforme | |
| 105708957 | 10570895 | Fatigue | |
| 105708957 | 10570895 | Fibromyalgia | |
| 105708957 | 10570895 | Gingival bleeding | |
| 105708957 | 10570895 | Gingival recession | |
| 105708957 | 10570895 | Hepatic enzyme increased | |
| 105708957 | 10570895 | Joint swelling | |
| 105708957 | 10570895 | Migraine | |
| 105708957 | 10570895 | Nausea | |
| 105708957 | 10570895 | Pain | |
| 105708957 | 10570895 | Peripheral swelling | |
| 105708957 | 10570895 | Pyrexia | |
| 105708957 | 10570895 | Rash | |
| 105708957 | 10570895 | Sensitivity of teeth |
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 |
|---|---|---|---|---|---|---|
| 105708957 | 10570895 | 1 | 20121221 | 0 | ||
| 105708957 | 10570895 | 2 | 20121221 | 0 | ||
| 105708957 | 10570895 | 3 | 20121221 | 0 | ||
| 105708957 | 10570895 | 4 | 20121221 | 0 | ||
| 105708957 | 10570895 | 5 | 201212 | 0 | ||
| 105708957 | 10570895 | 6 | 20121221 | 0 | ||
| 105708957 | 10570895 | 7 | 20121221 | 0 |