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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123234154 | 12323415 | 4 | F | 2016 | 20160816 | 20160502 | 20160822 | EXP | CA-JNJFOC-20160426673 | JANSSEN | 66.73 | YR | E | M | Y | 54.80000 | KG | 20160822 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123234154 | 12323415 | 1 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 123234154 | 12323415 | 2 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | INFUSION DURATION: NO LESS THAN 2 HOURS | N | GAM08012 | 0 | 300 | MG | LYOPHILIZED POWDER | |||||
| 123234154 | 12323415 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012 | 0 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 123234154 | 12323415 | 4 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | GAM08012 | 103772 | 300 | MG | LYOPHILIZED POWDER | ||||||
| 123234154 | 12323415 | 5 | C | ENAPRIL | ENALAPRIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123234154 | 12323415 | 6 | C | MORPHINE | MORPHINE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123234154 | 12323415 | 7 | C | ALLOPURINOL. | ALLOPURINOL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123234154 | 12323415 | 8 | C | METOPROLOL. | METOPROLOL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123234154 | 12323415 | 9 | C | NITROGLYCERIN. | NITROGLYCERIN | 1 | Unknown | 0 | PATCH | ||||||||||
| 123234154 | 12323415 | 10 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123234154 | 12323415 | 11 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123234154 | 12323415 | 12 | C | CALCIUM | CALCIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123234154 | 12323415 | 13 | C | CYANOCOBALAMIN. | CYANOCOBALAMIN | 1 | Unknown | 0 | INJECTION | ||||||||||
| 123234154 | 12323415 | 14 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123234154 | 12323415 | 15 | C | ASA | ASPIRIN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123234154 | 12323415 | 16 | C | IMOVANE | ZOPICLONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123234154 | 12323415 | 17 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123234154 | 12323415 | 18 | C | HYDROXYUREA. | HYDROXYUREA | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123234154 | 12323415 | 19 | C | TESTOSTERONE. | TESTOSTERONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123234154 | 12323415 | 20 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 123234154 | 12323415 | 21 | C | NICOTINE. | NICOTINE | 1 | Unknown | 0 | INHALATION | ||||||||||
| 123234154 | 12323415 | 22 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123234154 | 12323415 | 1 | Colitis ulcerative |
| 123234154 | 12323415 | 2 | Colitis ulcerative |
| 123234154 | 12323415 | 3 | Colitis ulcerative |
| 123234154 | 12323415 | 4 | Colitis ulcerative |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123234154 | 12323415 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123234154 | 12323415 | Abdominal pain | |
| 123234154 | 12323415 | Asthenia | |
| 123234154 | 12323415 | Feeling hot | |
| 123234154 | 12323415 | Frequent bowel movements | |
| 123234154 | 12323415 | General physical health deterioration | |
| 123234154 | 12323415 | Haematochezia | |
| 123234154 | 12323415 | Hyperhidrosis |
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 |
|---|---|---|---|---|---|---|
| 123234154 | 12323415 | 1 | 20160314 | 0 | ||
| 123234154 | 12323415 | 2 | 20160426 | 0 | ||
| 123234154 | 12323415 | 3 | 20160621 | 0 | ||
| 123234154 | 12323415 | 4 | 20160816 | 0 |