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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119116696 | 11911669 | 6 | F | 2015 | 20160726 | 20160112 | 20160803 | EXP | US-JNJFOC-20160107856 | JANSSEN | 71.87 | YR | E | F | Y | 50.80000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119116696 | 11911669 | 1 | PS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | Y | N | UNKNOWN | 125289 | 100 | MG | SOLUTION FOR INJECTION | /month | ||||
| 119116696 | 11911669 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 8.5 | MG | TABLET | |||||||
| 119116696 | 11911669 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 40 | MG | TABLET | BID | ||||||
| 119116696 | 11911669 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 10 | MG | TABLET | BID | ||||||
| 119116696 | 11911669 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 9.5 | MG | TABLET | |||||||
| 119116696 | 11911669 | 6 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Oral | U | 0 | 250 | MG | CAPSULE | QD | ||||||
| 119116696 | 11911669 | 7 | C | SUCRALFATE. | SUCRALFATE | 1 | Unknown | 0 | 1 | G | UNSPECIFIED | QID | |||||||
| 119116696 | 11911669 | 8 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 40 | MG | UNSPECIFIED | QD | |||||||
| 119116696 | 11911669 | 9 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | 0 | 125 | MG | UNSPECIFIED | QD | |||||||
| 119116696 | 11911669 | 10 | C | ELMIRON | PENTOSAN POLYSULFATE SODIUM | 1 | Oral | 0 | 200 | MG | CAPSULE | BID | |||||||
| 119116696 | 11911669 | 11 | C | ELMIRON | PENTOSAN POLYSULFATE SODIUM | 1 | Oral | 0 | 100 | MG | CAPSULE | BID | |||||||
| 119116696 | 11911669 | 12 | C | NEURONTIN | GABAPENTIN | 1 | Unknown | 0 | 300 | MG | UNSPECIFIED | TID | |||||||
| 119116696 | 11911669 | 13 | C | RESTASIS | CYCLOSPORINE | 1 | Unknown | 0 | .4 | ML | UNSPECIFIED | ||||||||
| 119116696 | 11911669 | 14 | C | URSODIOL. | URSODIOL | 1 | Unknown | 0 | 300 | MG | UNSPECIFIED | BID | |||||||
| 119116696 | 11911669 | 15 | C | TENORMIN | ATENOLOL | 1 | Unknown | 0 | 25 | MG | UNSPECIFIED | ||||||||
| 119116696 | 11911669 | 16 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | Unknown | 0 | 100 | MG | UNSPECIFIED | ||||||||
| 119116696 | 11911669 | 17 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | AS NEEDED | 0 | 1 | MG | UNSPECIFIED | |||||||
| 119116696 | 11911669 | 18 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 119116696 | 11911669 | 19 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 0 | 125 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119116696 | 11911669 | 1 | Colitis ulcerative |
| 119116696 | 11911669 | 2 | Colitis ulcerative |
| 119116696 | 11911669 | 3 | Colitis ulcerative |
| 119116696 | 11911669 | 4 | Colitis ulcerative |
| 119116696 | 11911669 | 5 | Colitis ulcerative |
| 119116696 | 11911669 | 6 | Clostridium difficile infection |
| 119116696 | 11911669 | 8 | Impaired gastric emptying |
| 119116696 | 11911669 | 9 | Thyroid disorder |
| 119116696 | 11911669 | 10 | Cystitis interstitial |
| 119116696 | 11911669 | 11 | Cystitis interstitial |
| 119116696 | 11911669 | 12 | Cystitis interstitial |
| 119116696 | 11911669 | 13 | Dry eye |
| 119116696 | 11911669 | 14 | Cholelithiasis |
| 119116696 | 11911669 | 15 | Migraine |
| 119116696 | 11911669 | 16 | Migraine |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119116696 | 11911669 | HO |
| 119116696 | 11911669 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119116696 | 11911669 | Adverse drug reaction | |
| 119116696 | 11911669 | Anxiety | |
| 119116696 | 11911669 | Avulsion fracture | |
| 119116696 | 11911669 | Back pain | |
| 119116696 | 11911669 | Bone pain | |
| 119116696 | 11911669 | Clostridium difficile infection | |
| 119116696 | 11911669 | Colitis ulcerative | |
| 119116696 | 11911669 | Diabetes mellitus | |
| 119116696 | 11911669 | Formication | |
| 119116696 | 11911669 | Limb injury | |
| 119116696 | 11911669 | Meningitis aseptic | |
| 119116696 | 11911669 | Paraesthesia | |
| 119116696 | 11911669 | Pruritus |
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 |
|---|---|---|---|---|---|---|
| 119116696 | 11911669 | 1 | 20150811 | 0 | ||
| 119116696 | 11911669 | 3 | 20150608 | 0 | ||
| 119116696 | 11911669 | 4 | 20150921 | 0 | ||
| 119116696 | 11911669 | 6 | 20150918 | 20160108 | 0 | |
| 119116696 | 11911669 | 10 | 2006 | 0 |