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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124468522 | 12446852 | 2 | F | 2009 | 20160725 | 20160608 | 20160802 | EXP | CA-JNJFOC-20151125424 | JANSSEN | 37.31 | YR | A | F | Y | 54.00000 | KG | 20160802 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
124468522 | 12446852 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FLM04014;FLM04014 | 0 | LYOPHILIZED POWDER | |||||||
124468522 | 12446852 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FLM04014;FLM04014 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
124468522 | 12446852 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FLM04014;FLM04014 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
124468522 | 12446852 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FLM04014;FLM04014 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
124468522 | 12446852 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FLM04014;FLM04014 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
124468522 | 12446852 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FLM04014;FLM04014 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
124468522 | 12446852 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FLM04014;FLM04014 | 0 | LYOPHILIZED POWDER | |||||||
124468522 | 12446852 | 8 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FLM04014;FLM04014 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
124468522 | 12446852 | 9 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FLM04014;FLM04014 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
124468522 | 12446852 | 10 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FLM04014;FLM04014 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
124468522 | 12446852 | 11 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FLM04014;FLM04014 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
124468522 | 12446852 | 12 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | FLM04014;FLM04014 | 103772 | 400 | MG | LYOPHILIZED POWDER | |||||
124468522 | 12446852 | 13 | SS | TYLENOL | ACETAMINOPHEN | 1 | Oral | U | U | 19872 | 500 | MG | UNSPECIFIED | ||||||
124468522 | 12446852 | 14 | SS | TYLENOL | ACETAMINOPHEN | 1 | Oral | U | U | 19872 | 500 | MG | UNSPECIFIED | ||||||
124468522 | 12446852 | 15 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | U | U | 0 | UNSPECIFIED | ||||||||
124468522 | 12446852 | 16 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | U | U | 999999 | 150 | MG | UNSPECIFIED | ||||||
124468522 | 12446852 | 17 | C | DICLECTIN | DOXYLAMINE SUCCINATEPYRIDOXINE HYDROCHLORIDE | 1 | Urethral | 0 | UNKNOWN | ||||||||||
124468522 | 12446852 | 18 | C | INSULIN | INSULIN NOS | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
124468522 | 12446852 | 19 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | 0 | 25 | UG | UNSPECIFIED | ||||||||
124468522 | 12446852 | 20 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intravenous (not otherwise specified) | 0 | 200 | MG | UNSPECIFIED | ||||||||
124468522 | 12446852 | 21 | C | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 0 | 200 | MG | UNSPECIFIED | ||||||||
124468522 | 12446852 | 22 | C | AERIUS | DESLORATADINE | 1 | Oral | 0 | 5 | MG | UNSPECIFIED |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
124468522 | 12446852 | 1 | Crohn's disease |
124468522 | 12446852 | 2 | Crohn's disease |
124468522 | 12446852 | 3 | Crohn's disease |
124468522 | 12446852 | 4 | Crohn's disease |
124468522 | 12446852 | 5 | Crohn's disease |
124468522 | 12446852 | 6 | Crohn's disease |
124468522 | 12446852 | 7 | Colitis ulcerative |
124468522 | 12446852 | 8 | Colitis ulcerative |
124468522 | 12446852 | 9 | Colitis ulcerative |
124468522 | 12446852 | 10 | Colitis ulcerative |
124468522 | 12446852 | 11 | Colitis ulcerative |
124468522 | 12446852 | 12 | Colitis ulcerative |
124468522 | 12446852 | 13 | Premedication |
124468522 | 12446852 | 14 | Premedication |
124468522 | 12446852 | 15 | Product used for unknown indication |
124468522 | 12446852 | 16 | Product used for unknown indication |
124468522 | 12446852 | 20 | Premedication |
124468522 | 12446852 | 21 | Premedication |
124468522 | 12446852 | 22 | Premedication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
124468522 | 12446852 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
124468522 | 12446852 | Caesarean section | |
124468522 | 12446852 | Dry mouth | |
124468522 | 12446852 | Erythema | |
124468522 | 12446852 | Exposure during pregnancy | |
124468522 | 12446852 | Infusion related reaction | |
124468522 | 12446852 | Malaise | |
124468522 | 12446852 | Nausea | |
124468522 | 12446852 | Pruritus | |
124468522 | 12446852 | Throat irritation | |
124468522 | 12446852 | Urticaria |
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 |
---|---|---|---|---|---|---|
124468522 | 12446852 | 1 | 20160601 | 0 | ||
124468522 | 12446852 | 2 | 2008 | 0 | ||
124468522 | 12446852 | 3 | 2009 | 0 | ||
124468522 | 12446852 | 4 | 20160725 | 0 | ||
124468522 | 12446852 | 5 | 20160406 | 0 | ||
124468522 | 12446852 | 6 | 20081019 | 0 | ||
124468522 | 12446852 | 7 | 20160601 | 0 | ||
124468522 | 12446852 | 8 | 20081019 | 0 | ||
124468522 | 12446852 | 9 | 2009 | 0 | ||
124468522 | 12446852 | 10 | 2008 | 0 | ||
124468522 | 12446852 | 11 | 20160725 | 0 | ||
124468522 | 12446852 | 12 | 20160406 | 0 | ||
124468522 | 12446852 | 14 | 20160725 | 0 | ||
124468522 | 12446852 | 15 | 2009 | 0 | ||
124468522 | 12446852 | 16 | 20160725 | 0 | ||
124468522 | 12446852 | 21 | 20160725 | 0 | ||
124468522 | 12446852 | 22 | 20160725 | 0 |