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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125743781 | 12574378 | 1 | I | 20160229 | 20160329 | 20160720 | 20160720 | EXP | US-JNJFOC-20160401172 | JANSSEN | 52.80 | YR | A | M | Y | 0.00000 | 20160720 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125743781 | 12574378 | 1 | PS | blinded; GOLIMUMA | GOLIMUMAB | 1 | Intravenous (not otherwise specified) | Y | N | 12723 | SOLUTION FOR INJECTION | ||||||||
| 125743781 | 12574378 | 2 | SS | blinded; GOLIMUMA | GOLIMUMAB | 1 | Intravenous (not otherwise specified) | Y | N | 125433 | SOLUTION FOR INJECTION | ||||||||
| 125743781 | 12574378 | 3 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Intravenous (not otherwise specified) | Y | 0 | SOLUTION FOR INJECTION | |||||||||
| 125743781 | 12574378 | 4 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | 1 | MG | UNSPECIFIED | QD | |||||||
| 125743781 | 12574378 | 5 | C | VITAMIN C | ASCORBIC ACID | 1 | Oral | 0 | 1000 | MG | UNSPECIFIED | QD | |||||||
| 125743781 | 12574378 | 6 | C | HYDROXYZINE HCL | HYDROXYZINE HYDROCHLORIDE | 1 | Oral | 0 | 25 | MG | UNSPECIFIED | TID | |||||||
| 125743781 | 12574378 | 7 | C | FISH OIL | FISH OIL | 1 | Oral | 0 | 2 | DF | CAPSULE | QD | |||||||
| 125743781 | 12574378 | 8 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | 0 | 20 | MG | UNSPECIFIED | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125743781 | 12574378 | 2 | Psoriatic arthropathy |
| 125743781 | 12574378 | 3 | Psoriatic arthropathy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125743781 | 12574378 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125743781 | 12574378 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 125743781 | 12574378 | 2 | 20150701 | 0 | ||
| 125743781 | 12574378 | 3 | 20150701 | 0 |