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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117189613 | 11718961 | 3 | F | 2015 | 20160802 | 20151109 | 20160810 | EXP | US-ABBVIE-15P-163-1488466-00 | ABBVIE | 44.89 | YR | F | Y | 86.26000 | KG | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117189613 | 11718961 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 1039182,10555922 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | ||||||
| 117189613 | 11718961 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 1039182,10555922 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||||
| 117189613 | 11718961 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 1039182,10555922 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | /wk | ||||||
| 117189613 | 11718961 | 4 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 117189613 | 11718961 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | 0 | ||||||||||||
| 117189613 | 11718961 | 6 | C | MESALAMINE. | MESALAMINE | 1 | 0 | ||||||||||||
| 117189613 | 11718961 | 7 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 117189613 | 11718961 | 8 | C | PIOGLITAZONE. | PIOGLITAZONE | 1 | 0 | ||||||||||||
| 117189613 | 11718961 | 9 | C | CLARINEX | DESLORATADINE | 1 | 0 | ||||||||||||
| 117189613 | 11718961 | 10 | C | TOPIRAMATE. | TOPIRAMATE | 1 | 0 | ||||||||||||
| 117189613 | 11718961 | 11 | C | FLORASTOR | SACCHAROMYCES CEREVISIAE | 1 | 0 | ||||||||||||
| 117189613 | 11718961 | 12 | C | AIRBORNE | HERBALSMINERALSVITAMINS | 1 | 0 | ||||||||||||
| 117189613 | 11718961 | 13 | C | NOVOLOG | INSULIN ASPART | 1 | 0 | ||||||||||||
| 117189613 | 11718961 | 14 | C | LANTUS | INSULIN GLARGINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117189613 | 11718961 | 1 | Colitis ulcerative |
| 117189613 | 11718961 | 2 | Ankylosing spondylitis |
| 117189613 | 11718961 | 4 | Product used for unknown indication |
| 117189613 | 11718961 | 5 | Colitis ulcerative |
| 117189613 | 11718961 | 6 | Colitis ulcerative |
| 117189613 | 11718961 | 7 | Diabetes mellitus |
| 117189613 | 11718961 | 8 | Diabetes mellitus |
| 117189613 | 11718961 | 9 | Seasonal allergy |
| 117189613 | 11718961 | 10 | Headache |
| 117189613 | 11718961 | 11 | Probiotic therapy |
| 117189613 | 11718961 | 12 | Vitamin supplementation |
| 117189613 | 11718961 | 13 | Diabetes mellitus |
| 117189613 | 11718961 | 14 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117189613 | 11718961 | HO |
| 117189613 | 11718961 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117189613 | 11718961 | Abdominal pain upper | |
| 117189613 | 11718961 | Arthralgia | |
| 117189613 | 11718961 | Back pain | |
| 117189613 | 11718961 | Colitis | |
| 117189613 | 11718961 | Colitis ulcerative | |
| 117189613 | 11718961 | Decreased appetite | |
| 117189613 | 11718961 | Dehydration | |
| 117189613 | 11718961 | Device issue | |
| 117189613 | 11718961 | Diabetes mellitus | |
| 117189613 | 11718961 | Fatigue | |
| 117189613 | 11718961 | Gastrointestinal haemorrhage | |
| 117189613 | 11718961 | Hospitalisation | |
| 117189613 | 11718961 | Incorrect dose administered | |
| 117189613 | 11718961 | Irritable bowel syndrome | |
| 117189613 | 11718961 | Pain in extremity | |
| 117189613 | 11718961 | Weight decreased | |
| 117189613 | 11718961 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 117189613 | 11718961 | 1 | 201404 | 201511 | 0 | |
| 117189613 | 11718961 | 2 | 201511 | 0 | ||
| 117189613 | 11718961 | 3 | 2015 | 0 |