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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124131595 | 12413159 | 5 | F | 20160404 | 20160908 | 20160527 | 20160920 | EXP | CA-TAKEDA-2016TUS006121 | TAKEDA | 30.00 | YR | M | Y | 0.00000 | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124131595 | 12413159 | 1 | PS | Vedolizumab | VEDOLIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, UNK | 343475 | 125476 | 300 | MG | POWDER FOR SOLUTION FOR INFUSION | ||||||
| 124131595 | 12413159 | 2 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 50 MG, UNK | U | 0 | 50 | MG | |||||||
| 124131595 | 12413159 | 3 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124131595 | 12413159 | 1 | Colitis ulcerative |
| 124131595 | 12413159 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124131595 | 12413159 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124131595 | 12413159 | Aggression | |
| 124131595 | 12413159 | Arthralgia | |
| 124131595 | 12413159 | Balance disorder | |
| 124131595 | 12413159 | Colitis ulcerative | |
| 124131595 | 12413159 | Deafness unilateral | |
| 124131595 | 12413159 | Disturbance in attention | |
| 124131595 | 12413159 | Dizziness | |
| 124131595 | 12413159 | Dry eye | |
| 124131595 | 12413159 | Dysarthria | |
| 124131595 | 12413159 | Eye irritation | |
| 124131595 | 12413159 | Fatigue | |
| 124131595 | 12413159 | Headache | |
| 124131595 | 12413159 | Hypoaesthesia | |
| 124131595 | 12413159 | Infusion related reaction | |
| 124131595 | 12413159 | Irritability | |
| 124131595 | 12413159 | Nausea | |
| 124131595 | 12413159 | Pain in extremity | |
| 124131595 | 12413159 | Productive cough | |
| 124131595 | 12413159 | Pyrexia | |
| 124131595 | 12413159 | Sluggishness | |
| 124131595 | 12413159 | Somnolence | |
| 124131595 | 12413159 | 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 |
|---|---|---|---|---|---|---|
| 124131595 | 12413159 | 1 | 20160404 | 0 |