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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127000221 | 12700022 | 1 | I | 201608 | 20160826 | 20160830 | 20160830 | EXP | US-DSJP-DSU-2016-128738 | DAIICHI | 0.00 | Y | 0.00000 | 20160830 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127000221 | 12700022 | 1 | PS | WELCHOL | COLESEVELAM HYDROCHLORIDE | 1 | Oral | 625 MG, BID | 21176 | 625 | MG | TABLET | BID | ||||||
| 127000221 | 12700022 | 2 | SS | WELCHOL | COLESEVELAM HYDROCHLORIDE | 1 | UNK | 0 | ORAL SUSPENSION | ||||||||||
| 127000221 | 12700022 | 3 | C | UNKNOWN MEDICATIONS | UNSPECIFIED INGREDIENT | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127000221 | 12700022 | 1 | Irritable bowel syndrome |
| 127000221 | 12700022 | 2 | Irritable bowel syndrome |
| 127000221 | 12700022 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127000221 | 12700022 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127000221 | 12700022 | Drug administration error | |
| 127000221 | 12700022 | Exostosis | |
| 127000221 | 12700022 | Off label use |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |