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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124802202 | 12480220 | 2 | F | 20101122 | 20160630 | 20160620 | 20160708 | EXP | US-JNJFOC-20160600257 | JANSSEN | 47.78 | YR | A | M | Y | 62.10000 | KG | 20160708 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124802202 | 12480220 | 1 | PS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | N | 103772 | 10 | MG/KG | LYOPHILIZED POWDER | |||||||
| 124802202 | 12480220 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124802202 | 12480220 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124802202 | 12480220 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124802202 | 12480220 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 50 | MG | UNSPECIFIED | ||||||||
| 124802202 | 12480220 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124802202 | 12480220 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124802202 | 12480220 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 124802202 | 12480220 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 50 | MG | UNSPECIFIED | ||||||||
| 124802202 | 12480220 | 10 | C | ALTEPLASE | ALTEPLASE | 1 | Intravenous (not otherwise specified) | INTRAVENOUS LINE PATENCY CHECKED | 0 | 3.8 | G | UNSPECIFIED | |||||||
| 124802202 | 12480220 | 11 | C | BACTRIM DS | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | DOSE: 800 TO 160 MG | 0 | UNSPECIFIED | |||||||||
| 124802202 | 12480220 | 12 | C | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 500 | MG | UNSPECIFIED | ||||||||
| 124802202 | 12480220 | 13 | C | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 1 | G | UNSPECIFIED | ||||||||
| 124802202 | 12480220 | 14 | C | COUMADIN | WARFARIN SODIUM | 1 | Oral | DOSE: 3-7 MG | 0 | UNSPECIFIED | |||||||||
| 124802202 | 12480220 | 15 | C | COUMADIN | WARFARIN SODIUM | 1 | Oral | DOSE: 3-7 MG | 0 | UNSPECIFIED | |||||||||
| 124802202 | 12480220 | 16 | C | DOXYCYCLINE. | DOXYCYCLINE | 1 | Oral | 0 | 100 | MG | UNSPECIFIED | ||||||||
| 124802202 | 12480220 | 17 | C | HEPARIN | HEPARIN SODIUM | 1 | Subcutaneous | DOSE: 5000 UNIT | 0 | 5000 | DF | UNSPECIFIED | |||||||
| 124802202 | 12480220 | 18 | C | HEPARIN | HEPARIN SODIUM | 1 | Intravenous (not otherwise specified) | 0 | UNSPECIFIED | ||||||||||
| 124802202 | 12480220 | 19 | C | HEPARIN | HEPARIN SODIUM | 1 | Intravenous (not otherwise specified) | 0 | UNSPECIFIED | ||||||||||
| 124802202 | 12480220 | 20 | C | LASIX | FUROSEMIDE | 1 | Intravenous (not otherwise specified) | DOSE: 60- 200 MG | 0 | UNSPECIFIED | |||||||||
| 124802202 | 12480220 | 21 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | Oral | 0 | 400 | MG | UNSPECIFIED | BID | |||||||
| 124802202 | 12480220 | 22 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Intravenous (not otherwise specified) | 0 | 2 | G | UNSPECIFIED | ||||||||
| 124802202 | 12480220 | 23 | C | MIRTAZAPINE. | MIRTAZAPINE | 1 | Oral | 0 | 7.5 | MG | UNSPECIFIED | ||||||||
| 124802202 | 12480220 | 24 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 40 | MG | UNSPECIFIED | QD | |||||||
| 124802202 | 12480220 | 25 | C | OXYCODONE | OXYCODONE | 1 | Oral | FREQUENCY: EVERY 4 HOURS (WHEN NECESSARY) | 0 | 5 | MG | UNSPECIFIED | |||||||
| 124802202 | 12480220 | 26 | C | VANCOMYCIN | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 0 | 1000 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124802202 | 12480220 | 1 | Crohn's disease |
| 124802202 | 12480220 | 2 | Glomerulonephritis |
| 124802202 | 12480220 | 3 | Glomerulonephritis |
| 124802202 | 12480220 | 4 | Glomerulonephritis |
| 124802202 | 12480220 | 5 | Glomerulonephritis |
| 124802202 | 12480220 | 6 | Crohn's disease |
| 124802202 | 12480220 | 7 | Crohn's disease |
| 124802202 | 12480220 | 8 | Crohn's disease |
| 124802202 | 12480220 | 9 | Crohn's disease |
| 124802202 | 12480220 | 14 | Pulmonary embolism |
| 124802202 | 12480220 | 15 | Deep vein thrombosis |
| 124802202 | 12480220 | 17 | Thrombosis prophylaxis |
| 124802202 | 12480220 | 18 | Thrombosis prophylaxis |
| 124802202 | 12480220 | 19 | Thrombosis prophylaxis |
| 124802202 | 12480220 | 20 | Urine output decreased |
| 124802202 | 12480220 | 21 | Mineral supplementation |
| 124802202 | 12480220 | 22 | Drug therapy |
| 124802202 | 12480220 | 23 | Depression |
| 124802202 | 12480220 | 24 | Dyspepsia |
| 124802202 | 12480220 | 25 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124802202 | 12480220 | HO |
| 124802202 | 12480220 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124802202 | 12480220 | Off label use | |
| 124802202 | 12480220 | Parainfluenzae virus infection | |
| 124802202 | 12480220 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 124802202 | 12480220 | 1 | 20101122 | 0 | ||
| 124802202 | 12480220 | 2 | 20140722 | 201409 | 0 | |
| 124802202 | 12480220 | 3 | 20121001 | 201212 | 0 | |
| 124802202 | 12480220 | 4 | 201007 | 201209 | 0 | |
| 124802202 | 12480220 | 5 | 20160429 | 0 | ||
| 124802202 | 12480220 | 6 | 20121001 | 201212 | 0 | |
| 124802202 | 12480220 | 7 | 201007 | 201209 | 0 | |
| 124802202 | 12480220 | 8 | 20140722 | 201409 | 0 | |
| 124802202 | 12480220 | 9 | 20160429 | 0 | ||
| 124802202 | 12480220 | 10 | 20160517 | 0 | ||
| 124802202 | 12480220 | 12 | 20160513 | 0 | ||
| 124802202 | 12480220 | 13 | 20160512 | 0 | ||
| 124802202 | 12480220 | 14 | 20160429 | 0 | ||
| 124802202 | 12480220 | 15 | 20160429 | 0 | ||
| 124802202 | 12480220 | 16 | 20160512 | 0 | ||
| 124802202 | 12480220 | 17 | 20160512 | 0 | ||
| 124802202 | 12480220 | 18 | 20160512 | 0 | ||
| 124802202 | 12480220 | 19 | 20160514 | 0 | ||
| 124802202 | 12480220 | 20 | 20160421 | 20160423 | 0 | |
| 124802202 | 12480220 | 21 | 20160502 | 0 | ||
| 124802202 | 12480220 | 22 | 20160513 | 0 | ||
| 124802202 | 12480220 | 23 | 20160423 | 0 | ||
| 124802202 | 12480220 | 24 | 201207 | 0 | ||
| 124802202 | 12480220 | 25 | 20160421 | 0 | ||
| 124802202 | 12480220 | 26 | 20160512 | 0 |