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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114736775 | 11473677 | 5 | F | 2015 | 20160922 | 20150908 | 20160926 | EXP | CA-ABBVIE-15K-028-1450969-00 | ABBVIE | 7.79 | YR | F | Y | 22.10000 | KG | 20160926 | MD | COUNTRY NOT SPECIFIED | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114736775 | 11473677 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 47038SP03 | 125057 | 20 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 114736775 | 11473677 | 2 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Oral | 0 | 50 | MG | QD | ||||||||
| 114736775 | 11473677 | 3 | C | URSODIOL. | URSODIOL | 1 | Oral | 0 | 250 | MG | BID | ||||||||
| 114736775 | 11473677 | 4 | C | VITAMIN K | PHYTONADIONE | 1 | Oral | 0 | 10 | MG | QD | ||||||||
| 114736775 | 11473677 | 5 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Oral | 0 | 1000 | MG | |||||||||
| 114736775 | 11473677 | 6 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 0 | ||||||||||||
| 114736775 | 11473677 | 7 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | Oral | 0 | 300 | MG | QD | ||||||||
| 114736775 | 11473677 | 8 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 0 | 12.5 | MG | QD | ||||||||
| 114736775 | 11473677 | 9 | C | MULTIVITAMIN | VITAMINS | 1 | Oral | 0 | 1 | DF | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114736775 | 11473677 | 1 | Crohn's disease |
| 114736775 | 11473677 | 2 | Crohn's disease |
| 114736775 | 11473677 | 3 | Cholangitis sclerosing |
| 114736775 | 11473677 | 4 | Cholangitis sclerosing |
| 114736775 | 11473677 | 5 | Cholangitis sclerosing |
| 114736775 | 11473677 | 6 | Crohn's disease |
| 114736775 | 11473677 | 7 | Crohn's disease |
| 114736775 | 11473677 | 8 | Product used for unknown indication |
| 114736775 | 11473677 | 9 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114736775 | 11473677 | HO |
| 114736775 | 11473677 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114736775 | 11473677 | Abdominal pain | |
| 114736775 | 11473677 | Anaemia | |
| 114736775 | 11473677 | Arthralgia | |
| 114736775 | 11473677 | Ascites | |
| 114736775 | 11473677 | Back pain | |
| 114736775 | 11473677 | Blood alkaline phosphatase increased | |
| 114736775 | 11473677 | Body height below normal | |
| 114736775 | 11473677 | Bone marrow failure | |
| 114736775 | 11473677 | Cough | |
| 114736775 | 11473677 | Failure to thrive | |
| 114736775 | 11473677 | Flank pain | |
| 114736775 | 11473677 | Hepatic function abnormal | |
| 114736775 | 11473677 | Hepatosplenomegaly | |
| 114736775 | 11473677 | Hyperammonaemia | |
| 114736775 | 11473677 | Hypotension | |
| 114736775 | 11473677 | Inflammatory bowel disease | |
| 114736775 | 11473677 | Jaundice | |
| 114736775 | 11473677 | Lower respiratory tract infection viral | |
| 114736775 | 11473677 | Malaise | |
| 114736775 | 11473677 | Malnutrition | |
| 114736775 | 11473677 | Pancytopenia | |
| 114736775 | 11473677 | Portal hypertensive gastropathy | |
| 114736775 | 11473677 | Pruritus | |
| 114736775 | 11473677 | Pyrexia | |
| 114736775 | 11473677 | Reticulocyte count increased | |
| 114736775 | 11473677 | Urine output decreased | |
| 114736775 | 11473677 | Varices oesophageal |
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 |
|---|---|---|---|---|---|---|
| 114736775 | 11473677 | 1 | 20150528 | 20150805 | 0 | |
| 114736775 | 11473677 | 2 | 20150427 | 20150812 | 0 | |
| 114736775 | 11473677 | 3 | 20141112 | 20150812 | 0 | |
| 114736775 | 11473677 | 4 | 20150212 | 0 | ||
| 114736775 | 11473677 | 5 | 20150122 | 0 | ||
| 114736775 | 11473677 | 7 | 20150122 | 0 | ||
| 114736775 | 11473677 | 8 | 201509 | 0 | ||
| 114736775 | 11473677 | 9 | 20150122 | 0 |