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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107010972 | 10701097 | 2 | F | 20141121 | 20160824 | 20150109 | 20160830 | EXP | SE-JNJFOC-20150102157 | JANSSEN | 13.00 | YR | C | F | Y | 0.00000 | 20160830 | MD | SE | SE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107010972 | 10701097 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 35 ML IN 215 ML NACL | N | N | 0 | 350 | MG | LYOPHILIZED POWDER | |||||
| 107010972 | 10701097 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 35 ML IN 215 ML NACL | N | N | 103772 | 350 | MG | LYOPHILIZED POWDER | |||||
| 107010972 | 10701097 | 3 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 107010972 | 10701097 | 4 | C | ASACOL | MESALAMINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 107010972 | 10701097 | 5 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 107010972 | 10701097 | 6 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 107010972 | 10701097 | 7 | C | CIRCADIN | MELATONIN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 107010972 | 10701097 | 8 | C | SERTRALINE HYDROCHLORIDE. | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 107010972 | 10701097 | 9 | C | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 107010972 | 10701097 | 1 | Colitis ulcerative |
| 107010972 | 10701097 | 2 | Colitis ulcerative |
| 107010972 | 10701097 | 9 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 107010972 | 10701097 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 107010972 | 10701097 | Arthralgia | |
| 107010972 | 10701097 | Myalgia |
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 |
|---|---|---|---|---|---|---|
| 107010972 | 10701097 | 1 | 20141205 | 20141205 | 0 | |
| 107010972 | 10701097 | 2 | 20141121 | 0 | ||
| 107010972 | 10701097 | 9 | 20141205 | 0 |