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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124174794 | 12417479 | 4 | F | 201406 | 20160912 | 20160530 | 20160919 | EXP | DK-JNJFOC-20150721644 | JANSSEN | 47.29 | YR | A | F | Y | 68.00000 | KG | 20160919 | OT | DK | DK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124174794 | 12417479 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | U | 0 | LYOPHILIZED POWDER | ||||||||
| 124174794 | 12417479 | 2 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | U | 103772 | 5 | MG/KG | LYOPHILIZED POWDER | ||||||
| 124174794 | 12417479 | 3 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | D | 0 | 50 | MG | UNSPECIFIED | |||||||
| 124174794 | 12417479 | 4 | C | BUDESONID | BUDESONIDE | 1 | Unknown | D | 0 | 6 | MG | UNSPECIFIED | |||||||
| 124174794 | 12417479 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | D | 0 | 7.5 | MG | UNSPECIFIED | /wk | ||||||
| 124174794 | 12417479 | 6 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | D | 0 | 5 | MG | UNSPECIFIED | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124174794 | 12417479 | 1 | Psoriasis |
| 124174794 | 12417479 | 2 | Psoriasis |
| 124174794 | 12417479 | 5 | Psoriasis |
| 124174794 | 12417479 | 6 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124174794 | 12417479 | OT |
| 124174794 | 12417479 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124174794 | 12417479 | Alanine aminotransferase increased | |
| 124174794 | 12417479 | Arthralgia | |
| 124174794 | 12417479 | Autoimmune hepatitis | |
| 124174794 | 12417479 | Back pain | |
| 124174794 | 12417479 | Chest discomfort | |
| 124174794 | 12417479 | Colitis microscopic | |
| 124174794 | 12417479 | Headache | |
| 124174794 | 12417479 | Oral fungal infection |
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 |
|---|---|---|---|---|---|---|
| 124174794 | 12417479 | 1 | 20140830 | 0 | ||
| 124174794 | 12417479 | 2 | 20140430 | 20140813 | 0 | |
| 124174794 | 12417479 | 5 | 20140316 | 20140623 | 0 | |
| 124174794 | 12417479 | 6 | 20140316 | 20140623 | 0 |