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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120753593 | 12075359 | 3 | F | 201507 | 20160711 | 20160213 | 20160718 | EXP | CR-ABBVIE-16K-039-1557305-00 | ABBVIE | 60.77 | YR | F | Y | 0.00000 | 20160718 | CN | COUNTRY NOT SPECIFIED | CR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120753593 | 12075359 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 120753593 | 12075359 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNKNOWN | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||||
| 120753593 | 12075359 | 3 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | Y | UNKNOWN | 0 | |||||||||
| 120753593 | 12075359 | 4 | C | METHOTREXATE. | METHOTREXATE | 1 | 0 | 2.5 | MG | TABLET | |||||||||
| 120753593 | 12075359 | 5 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | 0 | /wk | |||||||||||
| 120753593 | 12075359 | 6 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 0 | 1 | DF | TABLET | BID | |||||||
| 120753593 | 12075359 | 7 | C | XARELTO | RIVAROXABAN | 1 | 0 | QD | |||||||||||
| 120753593 | 12075359 | 8 | C | DAFLON | DIOSMINHESPERIDIN | 1 | 0 | QD | |||||||||||
| 120753593 | 12075359 | 9 | C | IRBESARTAN. | IRBESARTAN | 1 | Oral | 0 | .5 | DF | TABLET | ||||||||
| 120753593 | 12075359 | 10 | C | IRBESARTAN. | IRBESARTAN | 1 | Oral | 0 | .25 | DF | TABLET | ||||||||
| 120753593 | 12075359 | 11 | C | COREG | CARVEDILOL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120753593 | 12075359 | 1 | Rheumatoid arthritis |
| 120753593 | 12075359 | 3 | Rheumatoid arthritis |
| 120753593 | 12075359 | 4 | Rheumatoid arthritis |
| 120753593 | 12075359 | 5 | Product used for unknown indication |
| 120753593 | 12075359 | 6 | Diabetes mellitus |
| 120753593 | 12075359 | 7 | Product used for unknown indication |
| 120753593 | 12075359 | 8 | Product used for unknown indication |
| 120753593 | 12075359 | 9 | Hypertension |
| 120753593 | 12075359 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120753593 | 12075359 | HO |
| 120753593 | 12075359 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120753593 | 12075359 | Arrhythmia | |
| 120753593 | 12075359 | Asthenia | |
| 120753593 | 12075359 | Atrioventricular block | |
| 120753593 | 12075359 | Blood cholesterol increased | |
| 120753593 | 12075359 | Fatigue | |
| 120753593 | 12075359 | Heart rate decreased | |
| 120753593 | 12075359 | Hypotension | |
| 120753593 | 12075359 | Myocardial infarction |
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 |
|---|---|---|---|---|---|---|
| 120753593 | 12075359 | 1 | 2007 | 201602 | 0 |