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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127289431 | 12728943 | 1 | I | 20160525 | 20160907 | 20160909 | 20160909 | EXP | GB-CONCORDIA PHARMACEUTICALS INC.-GSH201609-004472 | CONCORDIA | 48.00 | YR | M | Y | 70.00000 | KG | 20160909 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127289431 | 12728943 | 1 | PS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 1569.58333 | MG | U | UNK | 21959 | 10 | MG | INJECTION | QD | |||
| 127289431 | 12728943 | 2 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 1569.58333 | MG | U | UNK | 21959 | 20 | MG | QD | ||||
| 127289431 | 12728943 | 3 | SS | ETANERCEPT | ETANERCEPT | 1 | Intradermal | 14.2797619 | MG | U | UNK | 0 | 1 | MG | INJECTION | /wk | |||
| 127289431 | 12728943 | 4 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Subcutaneous | 3453.57142 | MG | U | U | UNK | 0 | 25 | MG | /wk | |||
| 127289431 | 12728943 | 5 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 6 DAYS A WEEK | 0 | 5 | MG | ||||||||
| 127289431 | 12728943 | 6 | C | ORAMORPH | MORPHINE SULFATE | 1 | Oral | 0 | 5 | MG | |||||||||
| 127289431 | 12728943 | 7 | C | VOLTAROL | DICLOFENAC SODIUM | 1 | Rectal | 400 | MG | 0 | 50 | MG | SUPPOSITORY | BID |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127289431 | 12728943 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127289431 | 12728943 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 127289431 | 12728943 | 1 | 20151220 | 0 | ||
| 127289431 | 12728943 | 3 | 20160215 | 20160510 | 0 | |
| 127289431 | 12728943 | 4 | 20131001 | 0 | ||
| 127289431 | 12728943 | 5 | 20131001 | 0 | ||
| 127289431 | 12728943 | 6 | 20160521 | 0 | ||
| 127289431 | 12728943 | 7 | 20160521 | 20160523 | 0 |