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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124170522 | 12417052 | 2 | F | 2013 | 20160613 | 20160530 | 20160718 | EXP | US-UCBSA-2016019796 | UCB | 33.84 | YR | M | Y | 0.00000 | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124170522 | 12417052 | 1 | PS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | UNK | Y | U | 125160 | ||||||||
| 124170522 | 12417052 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNK, EV 2 WEEKS(QOW);40 MG/0.8ML KIT EVERY OTHER WEEK | 0 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | ||||||||
| 124170522 | 12417052 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNK, WEEKLY (QW),40MG/ML | 0 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||||||
| 124170522 | 12417052 | 4 | SS | 6-mp | MERCAPTOPURINE | 1 | 50 MG, ONCE DAILY (QD) | U | 0 | 50 | MG | TABLET | QD | ||||||
| 124170522 | 12417052 | 5 | SS | 6-mp | MERCAPTOPURINE | 1 | Oral | 100 MG, ONCE DAILY (QD) | U | 0 | 100 | MG | TABLET | QD | |||||
| 124170522 | 12417052 | 6 | C | IMODIUM A-D | LOPERAMIDE HYDROCHLORIDE | 1 | UNK UNK, AS NEEDED (PRN) | U | 0 | ||||||||||
| 124170522 | 12417052 | 7 | C | CLARITIN | LORATADINE | 1 | UNK | U | 0 | ||||||||||
| 124170522 | 12417052 | 8 | C | PREDNISONE. | PREDNISONE | 1 | 10 MG, 2 TABLET ONCE A DAY | Y | U | 0 | 10 | MG | TABLET | ||||||
| 124170522 | 12417052 | 9 | C | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 124170522 | 12417052 | 10 | C | CYANOCOBALAMIN. | CYANOCOBALAMIN | 1 | 1 ML, MONTHLY (QM) | U | 0 | 1 | ML | /month | |||||||
| 124170522 | 12417052 | 11 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | 2 DF, ONCE DAILY (QD) 400 UNIT CAPSULE | U | 0 | 2 | DF | QD | |||||||
| 124170522 | 12417052 | 12 | C | METRONIDAZOLE. | METRONIDAZOLE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124170522 | 12417052 | 1 | Product used for unknown indication |
| 124170522 | 12417052 | 2 | Crohn's disease |
| 124170522 | 12417052 | 4 | Product used for unknown indication |
| 124170522 | 12417052 | 6 | Product used for unknown indication |
| 124170522 | 12417052 | 7 | Product used for unknown indication |
| 124170522 | 12417052 | 8 | Product used for unknown indication |
| 124170522 | 12417052 | 9 | Product used for unknown indication |
| 124170522 | 12417052 | 10 | Product used for unknown indication |
| 124170522 | 12417052 | 11 | Product used for unknown indication |
| 124170522 | 12417052 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124170522 | 12417052 | HO |
| 124170522 | 12417052 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124170522 | 12417052 | Crohn's disease | |
| 124170522 | 12417052 | Drug ineffective | |
| 124170522 | 12417052 | Fatigue | |
| 124170522 | 12417052 | Intestinal obstruction | |
| 124170522 | 12417052 | Rectal abscess | |
| 124170522 | 12417052 | Skin cancer |
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 |
|---|---|---|---|---|---|---|
| 124170522 | 12417052 | 1 | 2013 | 2013 | 0 | |
| 124170522 | 12417052 | 2 | 201308 | 2013 | 0 | |
| 124170522 | 12417052 | 3 | 2013 | 0 | ||
| 124170522 | 12417052 | 5 | 201503 | 0 | ||
| 124170522 | 12417052 | 8 | 20130911 | 0 |