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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121394479 | 12139447 | 9 | F | 20160112 | 20160804 | 20160303 | 20160812 | EXP | JP-TAKEDA-2016TJP004216 | TAKEDA | 43.88 | YR | F | Y | 51.60000 | KG | 20160812 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121394479 | 12139447 | 1 | PS | MLN0002 | VEDOLIZUMAB | 1 | Intravenous drip | 300 MG, UNK | 125476 | 300 | MG | POWDER FOR SOLUTION FOR INFUSION | |||||||
| 121394479 | 12139447 | 2 | SS | Vedolizumab | VEDOLIZUMAB | 1 | Intravenous drip | UNKNOWN | 125476 | POWDER FOR SOLUTION FOR INFUSION | |||||||||
| 121394479 | 12139447 | 3 | SS | AZATHIOPRINE. | AZATHIOPRINE | 1 | Oral | 50 MG, BID | 0 | 50 | MG | FILM-COATED TABLET | BID | ||||||
| 121394479 | 12139447 | 4 | SS | ASACOL | MESALAMINE | 1 | Oral | 1200 MG, TID | 0 | 1200 | MG | TID | |||||||
| 121394479 | 12139447 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Oral | 2 MG, BID | 0 | 2 | MG | CAPSULE | BID | ||||||
| 121394479 | 12139447 | 6 | SS | Insulin | INSULIN NOS | 1 | Unknown | UNK | 0 | ||||||||||
| 121394479 | 12139447 | 7 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | UNK | 0 | ||||||||||
| 121394479 | 12139447 | 8 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | UNK | 0 | ||||||||||
| 121394479 | 12139447 | 9 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | UNK | 0 | ||||||||||
| 121394479 | 12139447 | 10 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | UNK | 0 | ||||||||||
| 121394479 | 12139447 | 11 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121394479 | 12139447 | 1 | Colitis ulcerative |
| 121394479 | 12139447 | 2 | Colitis ulcerative |
| 121394479 | 12139447 | 3 | Colitis ulcerative |
| 121394479 | 12139447 | 4 | Colitis ulcerative |
| 121394479 | 12139447 | 5 | Colitis ulcerative |
| 121394479 | 12139447 | 6 | Hyperglycaemia |
| 121394479 | 12139447 | 7 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121394479 | 12139447 | LT |
| 121394479 | 12139447 | DE |
| 121394479 | 12139447 | HO |
| 121394479 | 12139447 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121394479 | 12139447 | Acute respiratory distress syndrome | |
| 121394479 | 12139447 | Bronchopulmonary aspergillosis | |
| 121394479 | 12139447 | Hyperglycaemia | |
| 121394479 | 12139447 | Pneumocystis jirovecii pneumonia |
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 |
|---|---|---|---|---|---|---|
| 121394479 | 12139447 | 1 | 20151017 | 20151031 | 0 | |
| 121394479 | 12139447 | 3 | 20160202 | 0 | ||
| 121394479 | 12139447 | 4 | 20151226 | 0 | ||
| 121394479 | 12139447 | 5 | 20160201 | 0 | ||
| 121394479 | 12139447 | 6 | 20160113 | 0 | ||
| 121394479 | 12139447 | 7 | 20070628 | 20070926 | 0 | |
| 121394479 | 12139447 | 8 | 20071025 | 20080515 | 0 | |
| 121394479 | 12139447 | 9 | 20080926 | 20090114 | 0 | |
| 121394479 | 12139447 | 10 | 20101113 | 20110121 | 0 | |
| 121394479 | 12139447 | 11 | 20150919 | 0 |