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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109779072 | 10977907 | 2 | F | 201310 | 20160906 | 20150402 | 20160909 | EXP | US-ABBVIE-15K-163-1366809-00 | ABBVIE | 66.18 | YR | F | Y | 55.39000 | KG | 20160909 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109779072 | 10977907 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | U | 1056231 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 109779072 | 10977907 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | U | 1056231 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 109779072 | 10977907 | 3 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | 0 | ||||||||||||
| 109779072 | 10977907 | 4 | C | REMICADE | INFLIXIMAB | 1 | 0 | ||||||||||||
| 109779072 | 10977907 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109779072 | 10977907 | 1 | Crohn's disease |
| 109779072 | 10977907 | 3 | Product used for unknown indication |
| 109779072 | 10977907 | 4 | Product used for unknown indication |
| 109779072 | 10977907 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109779072 | 10977907 | OT |
| 109779072 | 10977907 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109779072 | 10977907 | Device issue | |
| 109779072 | 10977907 | Hypokalaemia | |
| 109779072 | 10977907 | Hypomagnesaemia | |
| 109779072 | 10977907 | Incorrect dose administered | |
| 109779072 | 10977907 | Joint stiffness | |
| 109779072 | 10977907 | Large intestinal obstruction | |
| 109779072 | 10977907 | Muscle spasms | |
| 109779072 | 10977907 | 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 |
|---|---|---|---|---|---|---|
| 109779072 | 10977907 | 1 | 201001 | 0 | ||
| 109779072 | 10977907 | 2 | 2012 | 0 |