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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125922842 | 12592284 | 2 | F | 201007 | 20160802 | 20160726 | 20160803 | PER | US-SHIRE-US201608918 | SHIRE | 49.94 | YR | F | Y | 58.50000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125922842 | 12592284 | 1 | PS | PENTASA | MESALAMINE | 1 | Oral | 1000 MG (TWO 500 MG CAPSULES), 2X/DAY:BID | 20049 | 1000 | MG | CAPSULE | BID | ||||||
| 125922842 | 12592284 | 2 | SS | PENTASA | MESALAMINE | 1 | 20049 | CAPSULE | |||||||||||
| 125922842 | 12592284 | 3 | C | VITAMIN C | ASCORBIC ACID | 1 | Oral | 500 MG, 1X/DAY:QD | 0 | 500 | MG | TABLET | QD | ||||||
| 125922842 | 12592284 | 4 | C | CALCIUM | CALCIUM | 1 | Oral | 600 MG, 1X/DAY:QD | 0 | 600 | MG | TABLET | QD | ||||||
| 125922842 | 12592284 | 5 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 1000 MG, 1X/DAY:QD | 0 | 1000 | MG | TABLET | QD | ||||||
| 125922842 | 12592284 | 6 | C | MULTIVITAMIN /07504101/ | VITAMINS | 1 | Oral | UNK (MG), 1X/DAY:QD | 0 | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125922842 | 12592284 | 1 | Crohn's disease |
| 125922842 | 12592284 | 2 | Prophylaxis |
| 125922842 | 12592284 | 3 | Supplementation therapy |
| 125922842 | 12592284 | 4 | Supplementation therapy |
| 125922842 | 12592284 | 5 | Product used for unknown indication |
| 125922842 | 12592284 | 6 | Supplementation therapy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125922842 | 12592284 | No adverse event | |
| 125922842 | 12592284 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 125922842 | 12592284 | 1 | 201007 | 0 |