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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125705111 | 12570511 | 1 | I | 201606 | 20160712 | 20160719 | 20160719 | EXP | GB-CONCORDIA PHARMACEUTICALS INC.-GSH201607-003611 | CONCORDIA | 20.00 | YR | M | Y | 76.80000 | KG | 20160719 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125705111 | 12570511 | 1 | PS | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | U | U | UNK | 21959 | ||||||||
| 125705111 | 12570511 | 2 | SS | INFLECTRA | INFLIXIMAB-DYYB | 1 | Intravenous (not otherwise specified) | FREQ-8 WEEKLY | U | U | UNK | 0 | 300 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125705111 | 12570511 | 2 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125705111 | 12570511 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125705111 | 12570511 | Cough | |
| 125705111 | 12570511 | Fatigue | |
| 125705111 | 12570511 | Hepatitis viral | |
| 125705111 | 12570511 | Influenza | |
| 125705111 | 12570511 | Liver function test abnormal |
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 |
|---|---|---|---|---|---|---|
| 125705111 | 12570511 | 1 | 201606 | 0 | ||
| 125705111 | 12570511 | 2 | 20151015 | 0 |