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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127832461 | 12783246 | 1 | I | 20160915 | 20160927 | 20160927 | EXP | GB-MLMSERVICE-20160912-0407541-1 | GB-ALKEM LABORATORIES LIMITED-GB-ALKEM-2016-00194 | ALKEM | 61.00 | YR | M | Y | 0.00000 | 20160927 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127832461 | 12783246 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | UNKNOWN | Y | 91249 | ||||||||||
| 127832461 | 12783246 | 2 | SS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | 2.5 G, QD | Y | 91249 | 2.5 | G | QD | |||||||
| 127832461 | 12783246 | 3 | SS | INFLIXIMAB | INFLIXIMAB | 1 | 5 MG/KG, INTRODUCED AT WEEKS 0, 2, AND 6, AND 8-WEEKLY THEREAFTER | Y | 0 | 5 | MG/KG | INFUSION | |||||||
| 127832461 | 12783246 | 4 | SS | INFLIXIMAB | INFLIXIMAB | 1 | 5 MG/KG,6 WEEKS | Y | 0 | 5 | MG/KG | INFUSION | |||||||
| 127832461 | 12783246 | 5 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | 1.5 MG/KG, UNK | Y | 0 | 1.5 | MG/KG | ||||||||
| 127832461 | 12783246 | 6 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | 40-60 MG, QD | Y | 0 | QD | |||||||||
| 127832461 | 12783246 | 7 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | 20 MG, QD | Y | 0 | 20 | MG | QD | |||||||
| 127832461 | 12783246 | 8 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | 40 MG, QD | Y | 0 | 40 | MG | QD | |||||||
| 127832461 | 12783246 | 9 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 1 G, 3 ? 1 G | 0 | 1 | G | ||||||||
| 127832461 | 12783246 | 10 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | UNKNOWN | 0 | |||||||||||
| 127832461 | 12783246 | 11 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | UNKNOWN | Y | Y | 0 | |||||||||
| 127832461 | 12783246 | 12 | C | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | 480 MG, THRICE A WEEK | 0 | 480 | MG | |||||||||
| 127832461 | 12783246 | 13 | C | TRIAMCINOLONE | TRIAMCINOLONE | 1 | Ophthalmic | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127832461 | 12783246 | 1 | Immunosuppression |
| 127832461 | 12783246 | 3 | Uveitis |
| 127832461 | 12783246 | 5 | Uveitis |
| 127832461 | 12783246 | 9 | Uveitis |
| 127832461 | 12783246 | 11 | Uveitis |
| 127832461 | 12783246 | 12 | Lymphopenia |
| 127832461 | 12783246 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127832461 | 12783246 | OT |
| 127832461 | 12783246 | HO |
| 127832461 | 12783246 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127832461 | 12783246 | Intestinal ischaemia | |
| 127832461 | 12783246 | Intestinal obstruction | |
| 127832461 | 12783246 | Multiple organ dysfunction syndrome | |
| 127832461 | 12783246 | Pneumocystis jirovecii infection | |
| 127832461 | 12783246 | Pneumonia | |
| 127832461 | 12783246 | Sepsis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |