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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126421402 | 12642140 | 2 | F | 2015 | 20160810 | 20160810 | 20160819 | EXP | US-ABBVIE-16K-163-1697294-00 | ABBVIE | 71.26 | YR | M | Y | 68.10000 | KG | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126421402 | 12642140 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 1054634 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | ||||||
| 126421402 | 12642140 | 2 | SS | MONOPRIL | FOSINOPRIL SODIUM | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 126421402 | 12642140 | 3 | C | COZAAR | LOSARTAN POTASSIUM | 1 | 0 | ||||||||||||
| 126421402 | 12642140 | 4 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 0 | ||||||||||||
| 126421402 | 12642140 | 5 | C | NORVASC | AMLODIPINE BESYLATE | 1 | 0 | ||||||||||||
| 126421402 | 12642140 | 6 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126421402 | 12642140 | 7 | C | LOSARTAN. | LOSARTAN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126421402 | 12642140 | 1 | Colitis ulcerative |
| 126421402 | 12642140 | 2 | Hypertension |
| 126421402 | 12642140 | 3 | Hypertension |
| 126421402 | 12642140 | 4 | Product used for unknown indication |
| 126421402 | 12642140 | 5 | Product used for unknown indication |
| 126421402 | 12642140 | 6 | Product used for unknown indication |
| 126421402 | 12642140 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126421402 | 12642140 | OT |
| 126421402 | 12642140 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126421402 | 12642140 | Contusion | |
| 126421402 | 12642140 | Erythema | |
| 126421402 | 12642140 | Lip swelling | |
| 126421402 | 12642140 | Mouth swelling | |
| 126421402 | 12642140 | Pruritus | |
| 126421402 | 12642140 | Spinal disorder | |
| 126421402 | 12642140 | Swollen tongue | |
| 126421402 | 12642140 | Testicular swelling | |
| 126421402 | 12642140 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 126421402 | 12642140 | 1 | 201410 | 0 |