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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124999273 | 12499927 | 3 | F | 20160401 | 20160831 | 20160627 | 20160909 | EXP | CA-JNJFOC-20160619138 | JANSSEN | 51.77 | YR | A | F | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124999273 | 12499927 | 1 | SS | STELARA | USTEKINUMAB | 1 | Subcutaneous | Y | N | 0 | 90 | MG | SOLUTION FOR INJECTION | ||||||
| 124999273 | 12499927 | 2 | SS | STELARA | USTEKINUMAB | 1 | Subcutaneous | Y | N | 0 | 90 | MG | SOLUTION FOR INJECTION | ||||||
| 124999273 | 12499927 | 3 | SS | STELARA | USTEKINUMAB | 1 | Subcutaneous | Y | N | 0 | 45 | MG | SOLUTION FOR INJECTION | ||||||
| 124999273 | 12499927 | 4 | SS | STELARA | USTEKINUMAB | 1 | Subcutaneous | Y | N | 0 | 90 | MG | SOLUTION FOR INJECTION | ||||||
| 124999273 | 12499927 | 5 | SS | STELARA | USTEKINUMAB | 1 | Subcutaneous | Y | N | 0 | 45 | MG | SOLUTION FOR INJECTION | ||||||
| 124999273 | 12499927 | 6 | PS | STELARA | USTEKINUMAB | 1 | Subcutaneous | Y | N | 125261 | 90 | MG | SOLUTION FOR INJECTION | ||||||
| 124999273 | 12499927 | 7 | SS | ZORAN | RANITIDINE HYDROCHLORIDE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 124999273 | 12499927 | 8 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | 0 | 50 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124999273 | 12499927 | 1 | Ankylosing spondylitis |
| 124999273 | 12499927 | 2 | Ankylosing spondylitis |
| 124999273 | 12499927 | 3 | Ankylosing spondylitis |
| 124999273 | 12499927 | 4 | Crohn's disease |
| 124999273 | 12499927 | 5 | Crohn's disease |
| 124999273 | 12499927 | 6 | Crohn's disease |
| 124999273 | 12499927 | 7 | Nausea |
| 124999273 | 12499927 | 8 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124999273 | 12499927 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124999273 | 12499927 | Constipation | |
| 124999273 | 12499927 | Fatigue | |
| 124999273 | 12499927 | Headache | |
| 124999273 | 12499927 | Injection site erythema | |
| 124999273 | 12499927 | Injection site pruritus | |
| 124999273 | 12499927 | Injection site reaction | |
| 124999273 | 12499927 | Intestinal resection | |
| 124999273 | 12499927 | Nausea | |
| 124999273 | 12499927 | Off label use | |
| 124999273 | 12499927 | Product use issue | |
| 124999273 | 12499927 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 124999273 | 12499927 | 1 | 20160617 | 0 | ||
| 124999273 | 12499927 | 2 | 20160330 | 0 | ||
| 124999273 | 12499927 | 3 | 20160815 | 0 | ||
| 124999273 | 12499927 | 4 | 20160617 | 0 | ||
| 124999273 | 12499927 | 5 | 20160815 | 0 | ||
| 124999273 | 12499927 | 6 | 20160330 | 0 |