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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125633611 | 12563361 | 1 | I | 2015 | 20160706 | 20160715 | 20160715 | EXP | US-ABBVIE-16K-163-1669994-00 | ABBVIE | 0.00 | F | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125633611 | 12563361 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE | 1057363 | 125057 | 160 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | ||||||
| 125633611 | 12563361 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE | 1057363 | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | ||||||
| 125633611 | 12563361 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 1057363 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | ||||||
| 125633611 | 12563361 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 1057363 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | /wk | ||||||
| 125633611 | 12563361 | 5 | SS | NORVASC | AMLODIPINE BESYLATE | 1 | Unknown | U | UNKNOWN | 0 | 10 | MG | QD | ||||||
| 125633611 | 12563361 | 6 | SS | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 125633611 | 12563361 | 7 | C | BENICAR | OLMESARTAN MEDOXOMIL | 1 | 0 | ||||||||||||
| 125633611 | 12563361 | 8 | C | METOPROLOL. | METOPROLOL | 1 | 0 | ||||||||||||
| 125633611 | 12563361 | 9 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | 0 | ||||||||||||
| 125633611 | 12563361 | 10 | C | ESTRADIOL. | ESTRADIOL | 1 | 0 | ||||||||||||
| 125633611 | 12563361 | 11 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125633611 | 12563361 | 12 | C | POTASSIUM | POTASSIUM | 1 | 0 | ||||||||||||
| 125633611 | 12563361 | 13 | C | MELATONIN | MELATONIN | 1 | 0 | ||||||||||||
| 125633611 | 12563361 | 14 | C | CHARCOAL | ACTIVATED CHARCOAL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125633611 | 12563361 | 1 | Crohn's disease |
| 125633611 | 12563361 | 5 | Product used for unknown indication |
| 125633611 | 12563361 | 6 | Blood cholesterol increased |
| 125633611 | 12563361 | 7 | Hypertension |
| 125633611 | 12563361 | 8 | Hypertension |
| 125633611 | 12563361 | 9 | Gastrooesophageal reflux disease |
| 125633611 | 12563361 | 10 | Hormone replacement therapy |
| 125633611 | 12563361 | 11 | Insomnia |
| 125633611 | 12563361 | 12 | Product used for unknown indication |
| 125633611 | 12563361 | 13 | Insomnia |
| 125633611 | 12563361 | 14 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125633611 | 12563361 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125633611 | 12563361 | Arthralgia | |
| 125633611 | 12563361 | Blood calcium increased | |
| 125633611 | 12563361 | Blood pressure increased | |
| 125633611 | 12563361 | Drug ineffective | |
| 125633611 | 12563361 | Dyspnoea | |
| 125633611 | 12563361 | Goitre | |
| 125633611 | 12563361 | Headache | |
| 125633611 | 12563361 | Joint swelling | |
| 125633611 | 12563361 | Parathyroid gland enlargement | |
| 125633611 | 12563361 | Peripheral swelling | |
| 125633611 | 12563361 | Tinnitus | |
| 125633611 | 12563361 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 125633611 | 12563361 | 1 | 201407 | 201407 | 0 | |
| 125633611 | 12563361 | 2 | 2014 | 2014 | 0 | |
| 125633611 | 12563361 | 3 | 2014 | 2015 | 0 | |
| 125633611 | 12563361 | 4 | 2015 | 0 | ||
| 125633611 | 12563361 | 6 | 201605 | 0 |