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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121000985 | 12100098 | 5 | F | 20140101 | 20160210 | 20160222 | 20160813 | EXP | BR-JNJFOC-20160212317 | JANSSEN | 21.10 | YR | A | F | Y | 59.00000 | KG | 20160812 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121000985 | 12100098 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 121000985 | 12100098 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 350 | MG | LYOPHILIZED POWDER | ||||||
| 121000985 | 12100098 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 0 | 350 | MG | LYOPHILIZED POWDER | ||||||
| 121000985 | 12100098 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | UNKNOWN | 103772 | 400 | MG | LYOPHILIZED POWDER | ||||||
| 121000985 | 12100098 | 5 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 121000985 | 12100098 | 6 | C | MELOXICAM. | MELOXICAM | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121000985 | 12100098 | 1 | Spondylitis |
| 121000985 | 12100098 | 2 | Spondylitis |
| 121000985 | 12100098 | 3 | Ankylosing spondylitis |
| 121000985 | 12100098 | 4 | Ankylosing spondylitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121000985 | 12100098 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121000985 | 12100098 | Arthralgia | |
| 121000985 | 12100098 | Atrophy | |
| 121000985 | 12100098 | Blood blister | |
| 121000985 | 12100098 | Drug dose omission | |
| 121000985 | 12100098 | Drug ineffective | |
| 121000985 | 12100098 | Joint swelling | |
| 121000985 | 12100098 | Off label use | |
| 121000985 | 12100098 | Peripheral swelling | |
| 121000985 | 12100098 | Product use issue | |
| 121000985 | 12100098 | Spondylitis | |
| 121000985 | 12100098 | Therapeutic response unexpected | |
| 121000985 | 12100098 | Uveitis | |
| 121000985 | 12100098 | Wound |
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 |
|---|---|---|---|---|---|---|
| 121000985 | 12100098 | 1 | 20151217 | 0 | ||
| 121000985 | 12100098 | 2 | 20140101 | 0 | ||
| 121000985 | 12100098 | 3 | 20140101 | 0 | ||
| 121000985 | 12100098 | 4 | 20151217 | 0 |