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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106134214 | 10613421 | 4 | F | 201402 | 20160817 | 20141128 | 20160831 | EXP | US-JNJFOC-20141116976 | JANSSEN | 17.80 | YR | T | F | Y | 80.29000 | KG | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106134214 | 10613421 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 4-6 WEEKS | Y | U | 0 | 10 | MG/KG | LYOPHILIZED POWDER | |||||
| 106134214 | 10613421 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | LYOPHILIZED POWDER | ||||||||
| 106134214 | 10613421 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | LYOPHILIZED POWDER | ||||||||
| 106134214 | 10613421 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | LYOPHILIZED POWDER | ||||||||
| 106134214 | 10613421 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 0 | LYOPHILIZED POWDER | ||||||||
| 106134214 | 10613421 | 6 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 4-6 WEEKS | Y | U | 0 | 10 | MG/KG | LYOPHILIZED POWDER | |||||
| 106134214 | 10613421 | 7 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | Y | U | 103772 | 700 | MG | LYOPHILIZED POWDER | ||||||
| 106134214 | 10613421 | 8 | SS | IMURAN | AZATHIOPRINE | 1 | Unknown | 0 | 100 | MG | UNSPECIFIED | ||||||||
| 106134214 | 10613421 | 9 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | 2500 | IU | UNSPECIFIED | ||||||||
| 106134214 | 10613421 | 10 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 0 | 1 | MG | UNSPECIFIED | ||||||||
| 106134214 | 10613421 | 11 | C | APRISO | MESALAMINE | 1 | Unknown | 0 | 1500 | MG | UNSPECIFIED | ||||||||
| 106134214 | 10613421 | 12 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 106134214 | 10613421 | 13 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 106134214 | 10613421 | 1 | Colitis ulcerative |
| 106134214 | 10613421 | 2 | Colitis ulcerative |
| 106134214 | 10613421 | 3 | Colitis ulcerative |
| 106134214 | 10613421 | 4 | Colitis ulcerative |
| 106134214 | 10613421 | 5 | Colitis ulcerative |
| 106134214 | 10613421 | 6 | Colitis ulcerative |
| 106134214 | 10613421 | 7 | Colitis ulcerative |
| 106134214 | 10613421 | 8 | Immunomodulatory therapy |
| 106134214 | 10613421 | 9 | Vitamin D deficiency |
| 106134214 | 10613421 | 10 | Vitamin B complex deficiency |
| 106134214 | 10613421 | 11 | Inflammation |
| 106134214 | 10613421 | 12 | Premedication |
| 106134214 | 10613421 | 13 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 106134214 | 10613421 | HO |
| 106134214 | 10613421 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106134214 | 10613421 | Anaemia | |
| 106134214 | 10613421 | Arthralgia | |
| 106134214 | 10613421 | Cerebrospinal fluid leakage | |
| 106134214 | 10613421 | Colitis ulcerative | |
| 106134214 | 10613421 | Dehydration | |
| 106134214 | 10613421 | Ependymoma | |
| 106134214 | 10613421 | Epstein-Barr virus antibody positive | |
| 106134214 | 10613421 | Hemiplegia | |
| 106134214 | 10613421 | Migraine | |
| 106134214 | 10613421 | Pyrexia | |
| 106134214 | 10613421 | Rotavirus test positive | |
| 106134214 | 10613421 | Vasculitis |
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 |
|---|---|---|---|---|---|---|
| 106134214 | 10613421 | 1 | 20141216 | 0 | ||
| 106134214 | 10613421 | 2 | 20150918 | 0 | ||
| 106134214 | 10613421 | 3 | 20151012 | 0 | ||
| 106134214 | 10613421 | 4 | 20150203 | 0 | ||
| 106134214 | 10613421 | 5 | 20121114 | 0 | ||
| 106134214 | 10613421 | 6 | 20141027 | 0 | ||
| 106134214 | 10613421 | 7 | 20140220 | 0 | ||
| 106134214 | 10613421 | 8 | 20131216 | 0 | ||
| 106134214 | 10613421 | 9 | 20120108 | 0 | ||
| 106134214 | 10613421 | 10 | 20130415 | 0 | ||
| 106134214 | 10613421 | 11 | 20131202 | 0 |