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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120200812 | 12020081 | 2 | F | 2015 | 20160907 | 20160206 | 20160915 | EXP | US-ABBVIE-15K-163-1462418-00 | ABBVIE | 77.51 | YR | F | Y | 59.02000 | KG | 20160915 | MD | COUNTRY NOT SPECIFIED | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120200812 | 12020081 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE | Y | U | 1037530,1059673 | 125057 | 160 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | ||||
| 120200812 | 12020081 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE, TWO WEEKS AFTER 160 MG DOSE | Y | U | 1037530,1059673 | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | ||||
| 120200812 | 12020081 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | FOUR WEEKS AFTER 160 MG DOSE | Y | U | 1037530,1059673 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||
| 120200812 | 12020081 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | 1037530,1059673 | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | ||||||
| 120200812 | 12020081 | 5 | C | WELCHOL | COLESEVELAM HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 120200812 | 12020081 | 6 | C | LISINOPRIL. | LISINOPRIL | 1 | 0 | ||||||||||||
| 120200812 | 12020081 | 7 | C | METOPROLOL. | METOPROLOL | 1 | 0 | ||||||||||||
| 120200812 | 12020081 | 8 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | 0 | INJECTION | /month | ||||||||||
| 120200812 | 12020081 | 9 | C | PENTASA | MESALAMINE | 1 | 0 | ||||||||||||
| 120200812 | 12020081 | 10 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | ||||||||||||
| 120200812 | 12020081 | 11 | C | LOVASTATIN. | LOVASTATIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120200812 | 12020081 | 1 | Crohn's disease |
| 120200812 | 12020081 | 5 | Diarrhoea |
| 120200812 | 12020081 | 6 | Hypertension |
| 120200812 | 12020081 | 7 | Hypertension |
| 120200812 | 12020081 | 8 | Crohn's disease |
| 120200812 | 12020081 | 9 | Product used for unknown indication |
| 120200812 | 12020081 | 10 | Product used for unknown indication |
| 120200812 | 12020081 | 11 | Blood cholesterol increased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120200812 | 12020081 | HO |
| 120200812 | 12020081 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120200812 | 12020081 | Adenocarcinoma pancreas | |
| 120200812 | 12020081 | Asthenia | |
| 120200812 | 12020081 | Cholecystitis | |
| 120200812 | 12020081 | Cholelithiasis | |
| 120200812 | 12020081 | Clostridium difficile infection | |
| 120200812 | 12020081 | Diabetes mellitus | |
| 120200812 | 12020081 | Fatigue | |
| 120200812 | 12020081 | Jejunectomy | |
| 120200812 | 12020081 | Lymphadenectomy | |
| 120200812 | 12020081 | Pancreatic duct dilatation | |
| 120200812 | 12020081 | Rash papular | |
| 120200812 | 12020081 | Splenectomy | |
| 120200812 | 12020081 | Wound haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 120200812 | 12020081 | 1 | 201211 | 201211 | 0 | |
| 120200812 | 12020081 | 2 | 2012 | 2012 | 0 | |
| 120200812 | 12020081 | 3 | 2012 | 20150821 | 0 | |
| 120200812 | 12020081 | 4 | 201604 | 0 |