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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116608694 | 11660869 | 4 | F | 201509 | 20160801 | 20151026 | 20160810 | EXP | BR-ABBVIE-15K-020-1487610-00 | ABBVIE | 72.48 | YR | F | Y | 56.00000 | KG | 20160810 | CN | COUNTRY NOT SPECIFIED | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116608694 | 11660869 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 59126XH02 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 116608694 | 11660869 | 2 | C | NORTRIPTYLINE | NORTRIPTYLINE | 1 | Oral | 0 | CAPSULE | ||||||||||
| 116608694 | 11660869 | 3 | C | DEFLAZACORT | DEFLAZACORT | 1 | Oral | 0 | CAPSULE | ||||||||||
| 116608694 | 11660869 | 4 | C | CALCIFEROL | ERGOCALCIFEROL | 1 | Oral | 0 | CHEWABLE TABLET | QD | |||||||||
| 116608694 | 11660869 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | 0 | 1 | DF | TABLET | /wk | |||||||
| 116608694 | 11660869 | 6 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | CAPSULE | /wk | |||||||||
| 116608694 | 11660869 | 7 | C | DEPURA | CHOLECALCIFEROL | 1 | Oral | 0 | ORAL DROPS | ||||||||||
| 116608694 | 11660869 | 8 | C | FLAVENOS | 2 | Oral | 0 | 500 | MG | COATED TABLET | BID | ||||||||
| 116608694 | 11660869 | 9 | C | LASIX | FUROSEMIDE | 1 | Oral | 0 | TABLET | ||||||||||
| 116608694 | 11660869 | 10 | C | PERIDAL | 2 | Oral | 0 | 10 | MG | TABLET | QID | ||||||||
| 116608694 | 11660869 | 11 | C | GARDENAL | PHENOBARBITAL | 1 | Oral | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116608694 | 11660869 | 1 | Ankylosing spondylitis |
| 116608694 | 11660869 | 2 | Ankylosing spondylitis |
| 116608694 | 11660869 | 3 | Ankylosing spondylitis |
| 116608694 | 11660869 | 4 | Ankylosing spondylitis |
| 116608694 | 11660869 | 5 | Ankylosing spondylitis |
| 116608694 | 11660869 | 6 | Ankylosing spondylitis |
| 116608694 | 11660869 | 7 | Vitamin D deficiency |
| 116608694 | 11660869 | 8 | Cardiovascular disorder |
| 116608694 | 11660869 | 9 | Swelling |
| 116608694 | 11660869 | 10 | Gastric disorder |
| 116608694 | 11660869 | 11 | Brain injury |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116608694 | 11660869 | HO |
| 116608694 | 11660869 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116608694 | 11660869 | Asthenia | |
| 116608694 | 11660869 | Colitis | |
| 116608694 | 11660869 | Constipation | |
| 116608694 | 11660869 | Gastrointestinal pain | |
| 116608694 | 11660869 | Malaise | |
| 116608694 | 11660869 | Syncope | |
| 116608694 | 11660869 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 116608694 | 11660869 | 1 | 20150605 | 0 | ||
| 116608694 | 11660869 | 2 | 2012 | 0 | ||
| 116608694 | 11660869 | 3 | 201504 | 0 | ||
| 116608694 | 11660869 | 5 | 201506 | 0 | ||
| 116608694 | 11660869 | 11 | 1996 | 0 |