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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125760973 | 12576097 | 3 | F | 20160603 | 20160818 | 20160720 | 20160826 | EXP | JP-JNJFOC-20160702099 | JANSSEN | 76.46 | YR | E | M | Y | 55.00000 | KG | 20160826 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125760973 | 12576097 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 300 | MG | LYOPHILIZED POWDER | |||||||
| 125760973 | 12576097 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 300 | MG | LYOPHILIZED POWDER | |||||||
| 125760973 | 12576097 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 0 | 300 | MG | LYOPHILIZED POWDER | |||||||
| 125760973 | 12576097 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | ALSO REPORTED AS 300 MG | N | 103772 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 125760973 | 12576097 | 5 | SS | IMURAN | AZATHIOPRINE | 1 | Oral | 0 | 50 | MG | UNSPECIFIED | QD | |||||||
| 125760973 | 12576097 | 6 | SS | IMURAN | AZATHIOPRINE | 1 | Oral | 0 | 75 | MG | UNSPECIFIED | QD | |||||||
| 125760973 | 12576097 | 7 | C | PENTASA | MESALAMINE | 1 | Rectal | 0 | 1 | G | UNSPECIFIED | QD | |||||||
| 125760973 | 12576097 | 8 | C | ASACOL | MESALAMINE | 1 | Oral | 0 | 1200 | MG | UNSPECIFIED | TID | |||||||
| 125760973 | 12576097 | 9 | C | MIYA-BM | CLOSTRIDIUM BUTYRICUM SPORES STRAIN M-55 | 1 | Oral | 60 MG IN TOTAL PER DAY | 0 | 20 | MG | UNSPECIFIED | TID | ||||||
| 125760973 | 12576097 | 10 | C | URSODEOXYCHOLIC ACID | URSODIOL | 1 | Oral | 300 MG IN TOTAL PER DAY | 0 | 100 | MG | UNSPECIFIED | TID | ||||||
| 125760973 | 12576097 | 11 | C | COSPANON | FLOPROPIONE | 1 | Oral | 120 MG TOTAL PER DAY | 0 | 40 | MG | UNSPECIFIED | TID | ||||||
| 125760973 | 12576097 | 12 | C | FOSAMAC | ALENDRONATE SODIUM | 1 | Oral | 0 | 35 | MG | UNSPECIFIED | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125760973 | 12576097 | 1 | Colitis ulcerative |
| 125760973 | 12576097 | 2 | Colitis ulcerative |
| 125760973 | 12576097 | 3 | Colitis ulcerative |
| 125760973 | 12576097 | 4 | Colitis ulcerative |
| 125760973 | 12576097 | 5 | Colitis ulcerative |
| 125760973 | 12576097 | 6 | Colitis ulcerative |
| 125760973 | 12576097 | 7 | Colitis ulcerative |
| 125760973 | 12576097 | 8 | Colitis ulcerative |
| 125760973 | 12576097 | 9 | Colitis ulcerative |
| 125760973 | 12576097 | 10 | Colitis ulcerative |
| 125760973 | 12576097 | 11 | Colitis ulcerative |
| 125760973 | 12576097 | 12 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125760973 | 12576097 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125760973 | 12576097 | Disseminated tuberculosis | |
| 125760973 | 12576097 | Pulmonary tuberculosis | |
| 125760973 | 12576097 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 125760973 | 12576097 | 1 | 20160315 | 0 | ||
| 125760973 | 12576097 | 2 | 20160329 | 0 | ||
| 125760973 | 12576097 | 3 | 20160621 | 0 | ||
| 125760973 | 12576097 | 4 | 20160426 | 0 | ||
| 125760973 | 12576097 | 5 | 20150609 | 20151124 | 0 | |
| 125760973 | 12576097 | 6 | 20151125 | 0 |