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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125887161 | 12588716 | 1 | I | 20160225 | 20160601 | 20160725 | 20160725 | PER | US-JNJFOC-20160607475 | JANSSEN | 49.68 | YR | A | M | Y | 0.00000 | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125887161 | 12588716 | 1 | PS | TYLENOL | ACETAMINOPHEN | 1 | Oral | U | U | 19872 | UNSPECIFIED | ||||||||
| 125887161 | 12588716 | 2 | SS | TYLENOL | ACETAMINOPHEN | 1 | Oral | U | U | 19872 | 1 | G | UNSPECIFIED | ||||||
| 125887161 | 12588716 | 3 | SS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | U | U | 999999 | 25 | MG | UNSPECIFIED | ||||||
| 125887161 | 12588716 | 4 | C | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 0 | 500 | MG | LYOPHILIZED POWDER | ||||||||
| 125887161 | 12588716 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | TAKE 5 TABLETS BY MOUTH EVERY SUNDAY, TAKE 5 TABLETS ONCE A WEEK | 0 | 2.5 | MG | TABLET | |||||||
| 125887161 | 12588716 | 6 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | TAKE DAILY EXCEPT FRIDAY AND SATURDAY | 0 | 1 | MG | TABLET | |||||||
| 125887161 | 12588716 | 7 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | TAKE 10000 UNITS BY MOUTH ONCE DAILY | 0 | TABLET | |||||||||
| 125887161 | 12588716 | 8 | C | ULTRAM | TRAMADOL HYDROCHLORIDE | 1 | Oral | TAKE 1 TABLET BU MOUTH TWICE DAILY AS NEEDED FOR PAIN | 0 | 50 | MG | UNSPECIFIED | |||||||
| 125887161 | 12588716 | 9 | C | PROBIOTICS NOS | PROBIOTICS NOS | 1 | Oral | TAKE 1 CAPSULE BY MOUTH ONCE DAILY | 0 | ||||||||||
| 125887161 | 12588716 | 10 | C | GARLIC. | GARLIC | 1 | Oral | TAKE BY MOUTH | 0 | UNSPECIFIED | |||||||||
| 125887161 | 12588716 | 11 | C | OMEGA-3 FATTY ACIDS | OMEGA-3 FATTY ACIDS | 1 | Oral | TAKE 1 TABLET BY MOUTH, ONCE DAILY | 0 | ||||||||||
| 125887161 | 12588716 | 12 | C | CALCIUM | CALCIUM | 1 | Oral | 0 | 500 | MG | TABLET | QD | |||||||
| 125887161 | 12588716 | 13 | C | VITAMINE C | ASCORBIC ACID | 1 | Unknown | TAKE 1 TABLET DAILY | 0 | 500 | MG | ||||||||
| 125887161 | 12588716 | 14 | C | MULTIVITAMINS | VITAMINS | 1 | Unknown | TAKE 1 TABLET DAILY | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125887161 | 12588716 | 2 | Premedication |
| 125887161 | 12588716 | 3 | Premedication |
| 125887161 | 12588716 | 4 | Crohn's disease |
| 125887161 | 12588716 | 5 | Product used for unknown indication |
| 125887161 | 12588716 | 6 | Product used for unknown indication |
| 125887161 | 12588716 | 7 | Product used for unknown indication |
| 125887161 | 12588716 | 8 | Product used for unknown indication |
| 125887161 | 12588716 | 9 | Product used for unknown indication |
| 125887161 | 12588716 | 10 | Product used for unknown indication |
| 125887161 | 12588716 | 11 | Product used for unknown indication |
| 125887161 | 12588716 | 12 | Product used for unknown indication |
| 125887161 | 12588716 | 13 | Product used for unknown indication |
| 125887161 | 12588716 | 14 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125887161 | 12588716 | Off label use | |
| 125887161 | 12588716 | Product used for unknown indication |
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 |
|---|---|---|---|---|---|---|
| 125887161 | 12588716 | 2 | 20160225 | 0 | ||
| 125887161 | 12588716 | 3 | 20160225 | 0 |