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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97016525 | 9701652 | 5 | F | 20130520 | 20160817 | 20131121 | 20160823 | EXP | JP-JNJFOC-20131110415 | JANSSEN | KO A, ICHIBE Y, SHIMIZU T. A CASE OF PARALYSIS OF THE SUPERIOR OBLIQUE MUSCLES DUE TO BRAIN STEM LESIONS IN THE COURSE OF ANTI-TNF-A MONOCLONAL ANTIBODY TREATMENT. 2013:59. KUBOTA A. A CASE OF A PATIENT WHO HAD SERIOUS ADVERSE EVENTS DURING TREATMENT FOR ULCERATIVE COLITIS. 2016:109. | 30.35 | YR | A | M | Y | 0.00000 | 20160823 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97016525 | 9701652 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | 350 | MG | LYOPHILIZED POWDER | ||||||
| 97016525 | 9701652 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | 350 | MG | LYOPHILIZED POWDER | ||||||
| 97016525 | 9701652 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 0 | 350 | MG | LYOPHILIZED POWDER | ||||||
| 97016525 | 9701652 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | N | 103772 | 350 | MG | LYOPHILIZED POWDER | ||||||
| 97016525 | 9701652 | 5 | C | ASACOL | MESALAMINE | 1 | Oral | 0 | UNSPECIFIED | ||||||||||
| 97016525 | 9701652 | 6 | C | BIO-THREE | HERBALS | 1 | Oral | 0 | 6 | DF | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 97016525 | 9701652 | 1 | Behcet's syndrome |
| 97016525 | 9701652 | 2 | Behcet's syndrome |
| 97016525 | 9701652 | 3 | Colitis ulcerative |
| 97016525 | 9701652 | 4 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 97016525 | 9701652 | HO |
| 97016525 | 9701652 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 97016525 | 9701652 | Behcet's syndrome | |
| 97016525 | 9701652 | Central nervous system lesion | |
| 97016525 | 9701652 | Colitis ulcerative | |
| 97016525 | 9701652 | Diplopia | |
| 97016525 | 9701652 | IVth nerve paralysis | |
| 97016525 | 9701652 | Paralysis | |
| 97016525 | 9701652 | Septic shock |
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 |
|---|---|---|---|---|---|---|
| 97016525 | 9701652 | 1 | 20130513 | 20130513 | 0 | |
| 97016525 | 9701652 | 2 | 20110804 | 0 | ||
| 97016525 | 9701652 | 3 | 20110804 | 0 | ||
| 97016525 | 9701652 | 4 | 20130513 | 20130513 | 0 |