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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 88882359 | 8888235 | 9 | F | 20121025 | 20160906 | 20121106 | 20160908 | EXP | CA-JNJFOC-20121011068 | JANSSEN | 42.75 | YR | A | F | Y | 100.00000 | KG | 20160908 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 88882359 | 8888235 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95012;FJM90015 | 0 | LYOPHILIZED POWDER | |||||||
| 88882359 | 8888235 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 5 MG/KG, RECEIVED 5 INFUSIONS | N | N | FKM95012;FJM90015 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||
| 88882359 | 8888235 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95012;FJM90015 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 88882359 | 8888235 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95012;FJM90015 | 0 | LYOPHILIZED POWDER | |||||||
| 88882359 | 8888235 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95012;FJM90015 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 88882359 | 8888235 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95012;FJM90015 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 88882359 | 8888235 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95012;FJM90015 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 88882359 | 8888235 | 8 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95012;FJM90015 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 88882359 | 8888235 | 9 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95012;FJM90015 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 88882359 | 8888235 | 10 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 5 MG/KG, RECEIVED 5 INFUSIONS | N | N | FKM95012;FJM90015 | 0 | 400 | MG | LYOPHILIZED POWDER | ||||
| 88882359 | 8888235 | 11 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95012;FJM90015 | 0 | LYOPHILIZED POWDER | |||||||
| 88882359 | 8888235 | 12 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95012;FJM90015 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 88882359 | 8888235 | 13 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95012;FJM90015 | 0 | 400 | MG | LYOPHILIZED POWDER | |||||
| 88882359 | 8888235 | 14 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | N | FKM95012;FJM90015 | 103772 | LYOPHILIZED POWDER | |||||||
| 88882359 | 8888235 | 15 | C | TAMOXIFEN | TAMOXIFEN | 1 | Unknown | 0 | 20 | MG | UNSPECIFIED | QD | |||||||
| 88882359 | 8888235 | 16 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 0 | 112.5 | MG | UNSPECIFIED | QD | |||||||
| 88882359 | 8888235 | 17 | C | MODAFINIL. | MODAFINIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 88882359 | 8888235 | 18 | C | CLONIDINE. | CLONIDINE | 1 | Unknown | 0 | 2.5 | MG | UNSPECIFIED | BID | |||||||
| 88882359 | 8888235 | 19 | C | LETROZOLE. | LETROZOLE | 1 | Unknown | 0 | 2.5 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 88882359 | 8888235 | 1 | Psoriatic arthropathy |
| 88882359 | 8888235 | 2 | Psoriatic arthropathy |
| 88882359 | 8888235 | 3 | Psoriatic arthropathy |
| 88882359 | 8888235 | 4 | Psoriatic arthropathy |
| 88882359 | 8888235 | 5 | Psoriatic arthropathy |
| 88882359 | 8888235 | 6 | Psoriatic arthropathy |
| 88882359 | 8888235 | 7 | Psoriatic arthropathy |
| 88882359 | 8888235 | 8 | Psoriasis |
| 88882359 | 8888235 | 9 | Psoriasis |
| 88882359 | 8888235 | 10 | Psoriasis |
| 88882359 | 8888235 | 11 | Psoriasis |
| 88882359 | 8888235 | 12 | Psoriasis |
| 88882359 | 8888235 | 13 | Psoriasis |
| 88882359 | 8888235 | 14 | Psoriasis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 88882359 | 8888235 | OT |
| 88882359 | 8888235 | HO |
| 88882359 | 8888235 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 88882359 | 8888235 | Breast cancer | |
| 88882359 | 8888235 | Off label use | |
| 88882359 | 8888235 | Product use issue | |
| 88882359 | 8888235 | Psoriasis |
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 |
|---|---|---|---|---|---|---|
| 88882359 | 8888235 | 1 | 201005 | 0 | ||
| 88882359 | 8888235 | 2 | 20100714 | 0 | ||
| 88882359 | 8888235 | 3 | 20100714 | 0 | ||
| 88882359 | 8888235 | 4 | 20130510 | 0 | ||
| 88882359 | 8888235 | 5 | 2012 | 0 | ||
| 88882359 | 8888235 | 6 | 20101004 | 20121030 | 0 | |
| 88882359 | 8888235 | 7 | 20160624 | 0 | ||
| 88882359 | 8888235 | 8 | 2012 | 0 | ||
| 88882359 | 8888235 | 9 | 20100714 | 0 | ||
| 88882359 | 8888235 | 10 | 20100714 | 0 | ||
| 88882359 | 8888235 | 11 | 20130510 | 0 | ||
| 88882359 | 8888235 | 12 | 20101004 | 20121030 | 0 | |
| 88882359 | 8888235 | 13 | 20160624 | 0 | ||
| 88882359 | 8888235 | 14 | 201005 | 0 |