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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127747301 | 12774730 | 1 | I | 20160915 | 20160923 | 20160923 | EXP | GB-HIKMA PHARMACEUTICALS CO. LTD-2016GB009076 | CELLTRION | JONES N. SEPSIS DURING IMMUNOSUPPRESSION FOR SIGHT-THREATENING UVEITIS: THE FLIP SIDE. OCULAR IMMUNOLOGY AND INFLAMMATION. 2016;1-4 | 0.00 | Y | 0.00000 | 20160922 | MD | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127747301 | 12774730 | 1 | PS | Infliximab | INFLIXIMAB | 1 | Unknown | 5 MG/KG, WEEKS 0, 2, AND 6, AND 8-WEEKLY | Y | U | 125544 | 5 | MG/KG | POWDER FOR SOLUTION FOR INFUSION | /wk | ||||
| 127747301 | 12774730 | 2 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 2.5 G, UNK | Y | U | 0 | 2.5 | G | ||||||
| 127747301 | 12774730 | 3 | SS | PREDNISOLONE /00016204/ | PREDNISOLONE | 1 | Unknown | 1.5 MG/KG, UNK | Y | 0 | 1.5 | MG/KG | |||||||
| 127747301 | 12774730 | 4 | SS | PREDNISOLONE /00016204/ | PREDNISOLONE | 1 | Unknown | 40- 60 MG, UNK | Y | 0 | 40 | MG | |||||||
| 127747301 | 12774730 | 5 | SS | PREDNISOLONE /00016204/ | PREDNISOLONE | 1 | Unknown | 20 MG, UNK | Y | 0 | 20 | MG | |||||||
| 127747301 | 12774730 | 6 | SS | PREDNISOLONE /00016204/ | PREDNISOLONE | 1 | Unknown | 40 MG, UNK | Y | 0 | 40 | MG | |||||||
| 127747301 | 12774730 | 7 | C | METHYLPREDNISOLONE /00049605/ | 2 | Intravenous (not otherwise specified) | 3 ? 1 G, UNK | 0 | 1 | G | |||||||||
| 127747301 | 12774730 | 8 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | 0 | ||||||||||||
| 127747301 | 12774730 | 9 | C | TRIMETHOPRIM. | TRIMETHOPRIM | 1 | 480 MG, 1/WEEK | 0 | 480 | MG | /wk | ||||||||
| 127747301 | 12774730 | 10 | C | SULFAMETHOXAZOLE | SULFAMETHOXAZOLE | 1 | 480 MG, 1/WEEK | 0 | 480 | MG | /wk | ||||||||
| 127747301 | 12774730 | 11 | C | TRIAMCINOLONE /00031902/ | 2 | Ophthalmic | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127747301 | 12774730 | 1 | Uveitis |
| 127747301 | 12774730 | 2 | Immunosuppression |
| 127747301 | 12774730 | 3 | Uveitis |
| 127747301 | 12774730 | 7 | Uveitis |
| 127747301 | 12774730 | 8 | Uveitis |
| 127747301 | 12774730 | 9 | Lymphopenia |
| 127747301 | 12774730 | 10 | Lymphopenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127747301 | 12774730 | LT |
| 127747301 | 12774730 | HO |
| 127747301 | 12774730 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127747301 | 12774730 | Intestinal obstruction | |
| 127747301 | 12774730 | Multiple organ dysfunction syndrome | |
| 127747301 | 12774730 | Off label use | |
| 127747301 | 12774730 | Pneumonia | |
| 127747301 | 12774730 | Sepsis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |