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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123249122 | 12324912 | 2 | F | 2016 | 20160729 | 20160502 | 20160811 | EXP | US-SHIRE-US201604732 | SHIRE | 65.11 | YR | M | Y | 78.46000 | KG | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123249122 | 12324912 | 1 | PS | PENTASA | MESALAMINE | 1 | Oral | 3 G, UNKNOWN (PER DAY) | Y | 20049 | 3 | G | CAPSULE | ||||||
| 123249122 | 12324912 | 2 | SS | PENTASA | MESALAMINE | 1 | Oral | 1000 MG, 4X/DAY:QID (TWO 500 MG CAPSULES) | Y | 20049 | 1000 | MG | CAPSULE | QID | |||||
| 123249122 | 12324912 | 3 | C | ALFUZOSIN | ALFUZOSIN | 1 | Unknown | UNK, 1X/DAY:QD | 0 | QD | |||||||||
| 123249122 | 12324912 | 4 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 100 ?G, 1X/DAY:QD | 0 | 100 | UG | TABLET | QD | ||||||
| 123249122 | 12324912 | 5 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 5 MG, 1X/DAY:QD | 0 | 5 | MG | TABLET | QD | ||||||
| 123249122 | 12324912 | 6 | C | KRILL OIL | DIETARY SUPPLEMENT | 1 | Unknown | UNK, UNKNOWN | 0 | CAPSULE | |||||||||
| 123249122 | 12324912 | 7 | C | KRILL OIL | DIETARY SUPPLEMENT | 1 | Unknown | UNK, UNKNOWN | 0 | CAPSULE | |||||||||
| 123249122 | 12324912 | 8 | C | MULTIVITAMIN /07504101/ | VITAMINS | 1 | Unknown | UNK, UNKNOWN | 0 | CAPSULE | |||||||||
| 123249122 | 12324912 | 9 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Unknown | UNK, UNKNOWN | 0 | CAPSULE | |||||||||
| 123249122 | 12324912 | 10 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | UNK, UNKNOWN | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123249122 | 12324912 | 1 | Colitis ulcerative |
| 123249122 | 12324912 | 2 | Rectal haemorrhage |
| 123249122 | 12324912 | 3 | Product used for unknown indication |
| 123249122 | 12324912 | 4 | Product used for unknown indication |
| 123249122 | 12324912 | 5 | Product used for unknown indication |
| 123249122 | 12324912 | 6 | Product used for unknown indication |
| 123249122 | 12324912 | 8 | Product used for unknown indication |
| 123249122 | 12324912 | 9 | Product used for unknown indication |
| 123249122 | 12324912 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123249122 | 12324912 | OT |
| 123249122 | 12324912 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123249122 | 12324912 | Abdominal distension | |
| 123249122 | 12324912 | Abnormal behaviour | |
| 123249122 | 12324912 | Change of bowel habit | |
| 123249122 | 12324912 | Choking | |
| 123249122 | 12324912 | Colitis | |
| 123249122 | 12324912 | Cough | |
| 123249122 | 12324912 | Dizziness | |
| 123249122 | 12324912 | Drug effect incomplete | |
| 123249122 | 12324912 | Drug ineffective | |
| 123249122 | 12324912 | Haematochezia | |
| 123249122 | 12324912 | Nausea | |
| 123249122 | 12324912 | Respiratory tract infection | |
| 123249122 | 12324912 | Upper respiratory tract infection | |
| 123249122 | 12324912 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 123249122 | 12324912 | 1 | 20160323 | 2016 | 0 | |
| 123249122 | 12324912 | 2 | 2016 | 20160413 | 0 | |
| 123249122 | 12324912 | 3 | 20151208 | 0 | ||
| 123249122 | 12324912 | 4 | 20151208 | 0 | ||
| 123249122 | 12324912 | 5 | 20151208 | 0 | ||
| 123249122 | 12324912 | 6 | 20160208 | 0 | ||
| 123249122 | 12324912 | 7 | 20160408 | 0 | ||
| 123249122 | 12324912 | 8 | 20151208 | 0 | ||
| 123249122 | 12324912 | 9 | 20160208 | 0 | ||
| 123249122 | 12324912 | 10 | 20160406 | 0 |