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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
120605236 | 12060523 | 6 | F | 20160120 | 20160624 | 20160210 | 20160701 | EXP | CA-JNJFOC-20160116736 | JANSSEN | 26.38 | YR | A | M | Y | 77.00000 | KG | 20160701 | CN | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
120605236 | 12060523 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | INDUCTION | N | FKM95012 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
120605236 | 12060523 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FKM95012 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
120605236 | 12060523 | 3 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | FKM95012 | 103772 | 400 | MG | LYOPHILIZED POWDER | ||||||
120605236 | 12060523 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 10 | MG | UNSPECIFIED | QD | |||||||
120605236 | 12060523 | 5 | C | NEUPOGEN | FILGRASTIM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
120605236 | 12060523 | 6 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | Unknown | DOSE: 240 UNITS UNSPECIFIED | 0 | UNSPECIFIED |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
120605236 | 12060523 | 1 | Colitis ulcerative |
120605236 | 12060523 | 2 | Colitis ulcerative |
120605236 | 12060523 | 3 | Colitis ulcerative |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
120605236 | 12060523 | HO |
120605236 | 12060523 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
120605236 | 12060523 | Abdominal pain | |
120605236 | 12060523 | Abnormal dreams | |
120605236 | 12060523 | Decreased appetite | |
120605236 | 12060523 | Diarrhoea | |
120605236 | 12060523 | Fatigue | |
120605236 | 12060523 | Haematochezia | |
120605236 | 12060523 | Haemoglobin decreased | |
120605236 | 12060523 | Infusion related reaction | |
120605236 | 12060523 | Neutrophil count decreased | |
120605236 | 12060523 | Pyrexia | |
120605236 | 12060523 | Rectal haemorrhage | |
120605236 | 12060523 | Splenectomy |
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 |
---|---|---|---|---|---|---|
120605236 | 12060523 | 1 | 20160120 | 0 | ||
120605236 | 12060523 | 2 | 20160204 | 0 | ||
120605236 | 12060523 | 3 | 201603 | 0 |