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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126482231 | 12648223 | 1 | I | 20160629 | 20160812 | 20160812 | EXP | DK-CELLTRION INC.-2016DK006441 | CELLTRION | JENSEN H, THOMSEN ST, HANSEN SS, MUNKSGAARD SB, LINDELOF M. SUPERIOR ORBITAL FISSURE SYNDROME AND OPHTHALMOPLEGIA CAUSED BY VARICELLA ZOSTER VIRUS WITH NO SKIN ERUPTION IN A PATIENT TREATED WITH TUMOR NECROSIS ALPHA INHIBITOR.. REPORTS IN NEUROLOGY. 2015;7 (3):221-226 | 0.00 | Y | 0.00000 | 20160812 | MD | DK | DK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126482231 | 12648223 | 1 | PS | Infliximab | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 400 MG, UNK | U | 125544 | 400 | MG | POWDER FOR SOLUTION FOR INFUSION | ||||||
| 126482231 | 12648223 | 2 | SS | Infliximab | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 400 MG, UNK | U | 125544 | 400 | MG | POWDER FOR SOLUTION FOR INFUSION | ||||||
| 126482231 | 12648223 | 3 | SS | MYCOPHENOLIC ACID. | MYCOPHENOLIC ACID | 1 | Unknown | 0 | |||||||||||
| 126482231 | 12648223 | 4 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 0 | |||||||||||
| 126482231 | 12648223 | 5 | C | GLUCOCORTICOIDS | UNSPECIFIED INGREDIENT | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126482231 | 12648223 | 1 | Pyoderma gangrenosum |
| 126482231 | 12648223 | 3 | Pyoderma gangrenosum |
| 126482231 | 12648223 | 4 | Pyoderma gangrenosum |
| 126482231 | 12648223 | 5 | Pyoderma gangrenosum |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126482231 | 12648223 | DE |
| 126482231 | 12648223 | HO |
| 126482231 | 12648223 | OT |
| 126482231 | 12648223 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126482231 | 12648223 | Encephalopathy | |
| 126482231 | 12648223 | Infection reactivation | |
| 126482231 | 12648223 | Off label use | |
| 126482231 | 12648223 | Orbital apex syndrome | |
| 126482231 | 12648223 | Varicella zoster virus infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |