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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127727501 | 12772750 | 1 | I | 20160913 | 20160922 | 20160922 | EXP | US-CELGENEUS-USA-2016093129 | CELGENE | BISHOP C, SUSKIND D. USTEKINUMAB IN PEDIATRIC CROHN DISEASE PATIENTS.. JOURNAL OF PEDIATRIC GASTROENTEROLOGY AND NUTRITION.. 2016 SEP 01;348-351. | 0.00 | T | F | Y | 44.50000 | KG | 20160922 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127727501 | 12772750 | 1 | PS | THALOMID | THALIDOMIDE | 1 | Oral | U | U | 20785 | CAPSULES | ||||||||
| 127727501 | 12772750 | 2 | SS | Ustekinumab | USTEKINUMAB | 1 | Subcutaneous | U | 0 | 90 | MG | UNKNOWN | |||||||
| 127727501 | 12772750 | 3 | SS | Ustekinumab | USTEKINUMAB | 1 | Subcutaneous | U | 0 | 90 | MG | UNKNOWN | |||||||
| 127727501 | 12772750 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127727501 | 12772750 | 1 | Crohn's disease |
| 127727501 | 12772750 | 2 | Crohn's disease |
| 127727501 | 12772750 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127727501 | 12772750 | HO |
| 127727501 | 12772750 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127727501 | 12772750 | Crohn's disease | |
| 127727501 | 12772750 | Device related infection | |
| 127727501 | 12772750 | Hypercoagulation | |
| 127727501 | 12772750 | Upper respiratory tract infection | |
| 127727501 | 12772750 | Urinary tract infection | |
| 127727501 | 12772750 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 127727501 | 12772750 | 2 | 201309 | 201404 | 0 |