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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121943633 | 12194363 | 3 | F | 2016 | 20160704 | 20160321 | 20160713 | EXP | RU-ABBVIE-16K-251-1585731-00 | ABBVIE | 13.00 | YR | F | Y | 0.00000 | 20160712 | PH | RU | RU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121943633 | 12194363 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 50064XD02 | 125057 | 40 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 121943633 | 12194363 | 2 | C | SALOFALK | MESALAMINE | 1 | 0 | 500 | MG | TID | |||||||||
| 121943633 | 12194363 | 3 | C | SALOFALK | MESALAMINE | 1 | 0 | 250 | MG | SUPPOSITORY | QD | ||||||||
| 121943633 | 12194363 | 4 | C | HEPARIN | HEPARIN SODIUM | 1 | 10 UNITS/KILOGRAM/HOUR | 0 | |||||||||||
| 121943633 | 12194363 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | 0 | ||||||||||||
| 121943633 | 12194363 | 6 | C | CEFTRIAXONE. | CEFTRIAXONE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121943633 | 12194363 | 1 | Juvenile idiopathic arthritis |
| 121943633 | 12194363 | 2 | Colitis ulcerative |
| 121943633 | 12194363 | 4 | Product used for unknown indication |
| 121943633 | 12194363 | 5 | Juvenile idiopathic arthritis |
| 121943633 | 12194363 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121943633 | 12194363 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121943633 | 12194363 | Acute kidney injury | |
| 121943633 | 12194363 | Anaemia | |
| 121943633 | 12194363 | Aspartate aminotransferase increased | |
| 121943633 | 12194363 | Blood creatinine increased | |
| 121943633 | 12194363 | Body temperature increased | |
| 121943633 | 12194363 | Colitis erosive | |
| 121943633 | 12194363 | Colitis ulcerative | |
| 121943633 | 12194363 | Duodenogastric reflux | |
| 121943633 | 12194363 | Erythema nodosum | |
| 121943633 | 12194363 | Gastritis | |
| 121943633 | 12194363 | Headache | |
| 121943633 | 12194363 | Inflammatory bowel disease | |
| 121943633 | 12194363 | Lacunar stroke | |
| 121943633 | 12194363 | Leukocytosis | |
| 121943633 | 12194363 | Maxillary sinus pseudocyst | |
| 121943633 | 12194363 | Meningitis | |
| 121943633 | 12194363 | Nausea | |
| 121943633 | 12194363 | Nephritis | |
| 121943633 | 12194363 | Proctitis ulcerative | |
| 121943633 | 12194363 | Purulent discharge | |
| 121943633 | 12194363 | T-lymphocyte count abnormal | |
| 121943633 | 12194363 | Vasculitis | |
| 121943633 | 12194363 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 121943633 | 12194363 | 1 | 20160226 | 201603 | 0 | |
| 121943633 | 12194363 | 2 | 20160408 | 0 | ||
| 121943633 | 12194363 | 3 | 2016 | 2016 | 0 | |
| 121943633 | 12194363 | 6 | 20160311 | 20160322 | 0 |