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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124750016 | 12475001 | 6 | F | 2015 | 20160909 | 20160617 | 20160921 | EXP | CA-SUN PHARMACEUTICAL INDUSTRIES LTD-2016US-118212 | RANBAXY | 53.00 | YR | F | Y | 0.00000 | 20160921 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124750016 | 12475001 | 1 | PS | PREDNISONE. | PREDNISONE | 1 | Oral | 40 MG, QD | 89247 | 40 | MG | ||||||||
| 124750016 | 12475001 | 2 | SS | Pantoprazole | PANTOPRAZOLE SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 124750016 | 12475001 | 3 | SS | ENTYVIO | VEDOLIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | 340236 | 0 | POWDER FOR SOLUTION FOR INFUSION | ||||||||
| 124750016 | 12475001 | 4 | SS | Tecta | PANTOPRAZOLE MAGNESIUM | 1 | Oral | 40 MG, QD | Y | 0 | 40 | MG | GASTRO-RESISTANT TABLET | ||||||
| 124750016 | 12475001 | 5 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | UNK | U | 0 | |||||||||
| 124750016 | 12475001 | 6 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 124750016 | 12475001 | 7 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124750016 | 12475001 | 1 | Colitis ulcerative |
| 124750016 | 12475001 | 2 | Dyspepsia |
| 124750016 | 12475001 | 3 | Colitis ulcerative |
| 124750016 | 12475001 | 4 | Dyspepsia |
| 124750016 | 12475001 | 5 | Product used for unknown indication |
| 124750016 | 12475001 | 6 | Product used for unknown indication |
| 124750016 | 12475001 | 7 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124750016 | 12475001 | OT |
| 124750016 | 12475001 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124750016 | 12475001 | Anaemia | |
| 124750016 | 12475001 | Arthralgia | |
| 124750016 | 12475001 | Back pain | |
| 124750016 | 12475001 | Colitis ulcerative | |
| 124750016 | 12475001 | Dry eye | |
| 124750016 | 12475001 | Dyspepsia | |
| 124750016 | 12475001 | Eye swelling | |
| 124750016 | 12475001 | Feeling abnormal | |
| 124750016 | 12475001 | Frequent bowel movements | |
| 124750016 | 12475001 | Glossitis | |
| 124750016 | 12475001 | Hypoaesthesia oral | |
| 124750016 | 12475001 | Muscular weakness | |
| 124750016 | 12475001 | Myalgia | |
| 124750016 | 12475001 | Pulmonary mass | |
| 124750016 | 12475001 | Throat irritation | |
| 124750016 | 12475001 | 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 |
|---|---|---|---|---|---|---|
| 124750016 | 12475001 | 2 | 201606 | 0 | ||
| 124750016 | 12475001 | 3 | 20160525 | 0 | ||
| 124750016 | 12475001 | 4 | 201501 | 20160607 | 0 |