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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126596791 | 12659679 | 1 | I | 2012 | 20160808 | 20160817 | 20160817 | EXP | US-SHIRE-US201610270 | SHIRE | 0.00 | F | Y | 46.71000 | KG | 20160817 | CN | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126596791 | 12659679 | 1 | PS | PENTASA | MESALAMINE | 1 | Oral | 1000 MG (FOUR 250 MG), 3X/DAY:TID | 20049 | 1000 | MG | CAPSULE | TID | ||||||
| 126596791 | 12659679 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 10 MG (TWO 5 MG), 1X/DAY:QD | 0 | 10 | MG | TABLET | QD | ||||||
| 126596791 | 12659679 | 3 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | 0.75 MG, 1X/DAY:QD | 0 | .75 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126596791 | 12659679 | 1 | Colitis ulcerative |
| 126596791 | 12659679 | 2 | Colitis ulcerative |
| 126596791 | 12659679 | 3 | Hypothyroidism |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126596791 | 12659679 | OT |
| 126596791 | 12659679 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126596791 | 12659679 | Arthritis | |
| 126596791 | 12659679 | Arthropathy | |
| 126596791 | 12659679 | Blood potassium decreased | |
| 126596791 | 12659679 | Blood test abnormal | |
| 126596791 | 12659679 | Condition aggravated | |
| 126596791 | 12659679 | Constipation | |
| 126596791 | 12659679 | Gastroenteritis viral | |
| 126596791 | 12659679 | Headache | |
| 126596791 | 12659679 | Joint swelling | |
| 126596791 | 12659679 | Ocular hyperaemia | |
| 126596791 | 12659679 | Peripheral swelling | |
| 126596791 | 12659679 | Peripheral venous disease | |
| 126596791 | 12659679 | Pulmonary embolism |
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 |
|---|---|---|---|---|---|---|
| 126596791 | 12659679 | 1 | 2003 | 0 | ||
| 126596791 | 12659679 | 2 | 2003 | 0 |