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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114696033 | 11469603 | 3 | F | 2014 | 20160826 | 20150908 | 20160902 | EXP | BR-ABBVIE-15K-020-1458017-00 | ABBVIE | 0.00 | M | Y | 78.00000 | KG | 20160902 | CN | COUNTRY NOT SPECIFIED | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114696033 | 11469603 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE | 57113XH03 | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 114696033 | 11469603 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | WEEK ONE | 57113XH03 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 114696033 | 11469603 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 57113XH03 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 114696033 | 11469603 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 57113XH03 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 114696033 | 11469603 | 5 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 57113XH03 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 114696033 | 11469603 | 6 | C | DIOVAN | VALSARTAN | 1 | Oral | 0 | TABLET | ||||||||||
| 114696033 | 11469603 | 7 | C | ROSUVASTATIN. | ROSUVASTATIN | 1 | Oral | 0 | TABLET | ||||||||||
| 114696033 | 11469603 | 8 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | Oral | 0 | TABLET | ||||||||||
| 114696033 | 11469603 | 9 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 0 | 10 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114696033 | 11469603 | 1 | Crohn's disease |
| 114696033 | 11469603 | 6 | Hypertension |
| 114696033 | 11469603 | 7 | Blood cholesterol abnormal |
| 114696033 | 11469603 | 8 | Vitamin supplementation |
| 114696033 | 11469603 | 9 | Blood triglycerides abnormal |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114696033 | 11469603 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114696033 | 11469603 | Blood pressure abnormal | |
| 114696033 | 11469603 | Connective tissue disorder | |
| 114696033 | 11469603 | Constipation | |
| 114696033 | 11469603 | Gastrointestinal motility disorder | |
| 114696033 | 11469603 | Inadequate diet | |
| 114696033 | 11469603 | Intestinal fibrosis | |
| 114696033 | 11469603 | Intestinal obstruction | |
| 114696033 | 11469603 | Pain | |
| 114696033 | 11469603 | Umbilical hernia | |
| 114696033 | 11469603 | Weight decreased | |
| 114696033 | 11469603 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 114696033 | 11469603 | 1 | 20120312 | 20120312 | 0 | |
| 114696033 | 11469603 | 2 | 201203 | 0 | ||
| 114696033 | 11469603 | 4 | 201506 | 0 | ||
| 114696033 | 11469603 | 7 | 2007 | 0 | ||
| 114696033 | 11469603 | 8 | 201506 | 0 |