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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123916222 | 12391622 | 2 | F | 2016 | 20160707 | 20160521 | 20160719 | EXP | US-ABBVIE-16K-163-1581020-00 | ABBVIE | 59.31 | YR | M | Y | 94.43000 | KG | 20160719 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123916222 | 12391622 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | 160 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | ||||||
| 123916222 | 12391622 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 123916222 | 12391622 | 3 | SS | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 123916222 | 12391622 | 4 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 400 MG TO 80 MG | 0 | BID | |||||||||
| 123916222 | 12391622 | 5 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | 400 MQ-80 MQ | 0 | TABLET | BID | |||||||||
| 123916222 | 12391622 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 1 TABLET AS DIRECTED BY MOUTH | 0 | 60 | MG | TABLET | |||||||
| 123916222 | 12391622 | 7 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 1 TABLET AS DIRECTED BY MOUTH | 0 | 40 | MG | TABLET | |||||||
| 123916222 | 12391622 | 8 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 1 TABLET AS DIRECTED BY MOUTH | 0 | 20 | MG | TABLET | |||||||
| 123916222 | 12391622 | 9 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | 0 | TID | |||||||||||
| 123916222 | 12391622 | 10 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 0 | 20 | MG | TABLET | BID | |||||||
| 123916222 | 12391622 | 11 | C | DOXYCYCLINE MONOHYDRATE | DOXYCYCLINE | 1 | Oral | WAIT TWO HOURS BEFORE TAKING MULTIVITAMINS | 0 | TABLET | BID | ||||||||
| 123916222 | 12391622 | 12 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 60 | MG | TABLET | ||||||||
| 123916222 | 12391622 | 13 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 40 | MG | TABLET | ||||||||
| 123916222 | 12391622 | 14 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 20 | MG | TABLET | ||||||||
| 123916222 | 12391622 | 15 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Oral | 0 | TABLET | BID | |||||||||
| 123916222 | 12391622 | 16 | C | ACETAMINOPHENHYDROCODONE BITARTRATE | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | HYDROCODONE 10 MG-ACETAMINOPHEN 325 MG, EVERY FOUR TO SIX HOURS AS NEEDED | 0 | TABLET | Q4H | ||||||||
| 123916222 | 12391622 | 17 | C | SUCRALFATE. | SUCRALFATE | 1 | Oral | 0 | TABLET | QD | |||||||||
| 123916222 | 12391622 | 18 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | Oral | 0 | TABLET | QD | |||||||||
| 123916222 | 12391622 | 19 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 0 | TABLET | QD | |||||||||
| 123916222 | 12391622 | 20 | C | BRILINTA | TICAGRELOR | 1 | Oral | 0 | TABLET | ||||||||||
| 123916222 | 12391622 | 21 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 0 | TABLET | QOD | |||||||||
| 123916222 | 12391622 | 22 | C | METOPROLOL SUCCINATE. | METOPROLOL SUCCINATE | 1 | Oral | EXTENDED RELEASE | 0 | 30 | MG | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123916222 | 12391622 | 1 | Crohn's disease |
| 123916222 | 12391622 | 3 | Product used for unknown indication |
| 123916222 | 12391622 | 4 | Product used for unknown indication |
| 123916222 | 12391622 | 6 | Product used for unknown indication |
| 123916222 | 12391622 | 9 | Product used for unknown indication |
| 123916222 | 12391622 | 10 | Product used for unknown indication |
| 123916222 | 12391622 | 11 | Product used for unknown indication |
| 123916222 | 12391622 | 12 | Product used for unknown indication |
| 123916222 | 12391622 | 15 | Product used for unknown indication |
| 123916222 | 12391622 | 16 | Product used for unknown indication |
| 123916222 | 12391622 | 17 | Product used for unknown indication |
| 123916222 | 12391622 | 18 | Product used for unknown indication |
| 123916222 | 12391622 | 19 | Product used for unknown indication |
| 123916222 | 12391622 | 20 | Product used for unknown indication |
| 123916222 | 12391622 | 21 | Product used for unknown indication |
| 123916222 | 12391622 | 22 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123916222 | 12391622 | HO |
| 123916222 | 12391622 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123916222 | 12391622 | Abdominal discomfort | |
| 123916222 | 12391622 | Adverse drug reaction | |
| 123916222 | 12391622 | Constipation | |
| 123916222 | 12391622 | Cough | |
| 123916222 | 12391622 | Dermatitis | |
| 123916222 | 12391622 | Dry skin | |
| 123916222 | 12391622 | Dyspnoea | |
| 123916222 | 12391622 | Eczema | |
| 123916222 | 12391622 | Erythema | |
| 123916222 | 12391622 | Feeling hot | |
| 123916222 | 12391622 | Hypersensitivity | |
| 123916222 | 12391622 | Immunodeficiency | |
| 123916222 | 12391622 | Inflammation | |
| 123916222 | 12391622 | Lichenification | |
| 123916222 | 12391622 | Lymphadenopathy | |
| 123916222 | 12391622 | Mass | |
| 123916222 | 12391622 | Melanocytic naevus | |
| 123916222 | 12391622 | Nausea | |
| 123916222 | 12391622 | Pain of skin | |
| 123916222 | 12391622 | Peripheral swelling | |
| 123916222 | 12391622 | Pulmonary function test abnormal | |
| 123916222 | 12391622 | Purulent discharge | |
| 123916222 | 12391622 | Rash maculo-papular | |
| 123916222 | 12391622 | Rash pustular | |
| 123916222 | 12391622 | Rash vesicular | |
| 123916222 | 12391622 | Scab | |
| 123916222 | 12391622 | Skin plaque | |
| 123916222 | 12391622 | Stent placement | |
| 123916222 | 12391622 | Tachycardia | |
| 123916222 | 12391622 | Wound | |
| 123916222 | 12391622 | Wound secretion |
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 |
|---|---|---|---|---|---|---|
| 123916222 | 12391622 | 1 | 20160106 | 20160106 | 0 | |
| 123916222 | 12391622 | 2 | 2016 | 20160302 | 0 |