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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109946363 | 10994636 | 3 | F | 2014 | 20160804 | 20150407 | 20160812 | EXP | BR-ABBVIE-15K-020-1370529-00 | ABBVIE | 78.60 | YR | F | Y | 44.00000 | KG | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109946363 | 10994636 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | WEEK ZERO, LOADING DOSE | Y | U | UNKNOWN | 125057 | 160 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||
| 109946363 | 10994636 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 109946363 | 10994636 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 109946363 | 10994636 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 109946363 | 10994636 | 5 | C | ACETYLSALICYLIC ACID | ASPIRIN | 1 | Oral | 0 | TABLET | ||||||||||
| 109946363 | 10994636 | 6 | C | EUTHYROX | LEVOTHYROXINE SODIUM | 1 | Oral | 0 | TABLET | ||||||||||
| 109946363 | 10994636 | 7 | C | POTASSIUM | POTASSIUM | 1 | 0 | ||||||||||||
| 109946363 | 10994636 | 8 | C | MAGNESIUM | MAGNESIUM | 1 | 0 | ||||||||||||
| 109946363 | 10994636 | 9 | C | AZATHIOPRINE. | AZATHIOPRINE | 1 | Oral | 0 | TABLET | ||||||||||
| 109946363 | 10994636 | 10 | C | ASPIRINA PREVENT | ASPIRIN | 1 | Oral | 0 | TABLET | ||||||||||
| 109946363 | 10994636 | 11 | C | RANITIDINE. | RANITIDINE | 1 | Oral | 0 | TABLET | ||||||||||
| 109946363 | 10994636 | 12 | C | RANITIDINE. | RANITIDINE | 1 | 0 | ||||||||||||
| 109946363 | 10994636 | 13 | C | SIMETHICONE (DIMETHICONE) | DIMETHICONE | 1 | Oral | 0 | 40 | GTT | ORAL DROPS | Q6H | |||||||
| 109946363 | 10994636 | 14 | C | SIMETHICONE (DIMETHICONE) | DIMETHICONE | 1 | 0 | ||||||||||||
| 109946363 | 10994636 | 15 | C | NORIPURUM | IRON POLYMALTOSE | 1 | Intravenous (not otherwise specified) | 0 | BIW | ||||||||||
| 109946363 | 10994636 | 16 | C | ERYTHROPOIETIN | ERYTHROPOIETIN | 1 | Subcutaneous | 0 | |||||||||||
| 109946363 | 10994636 | 17 | C | ATORVASTATIN | ATORVASTATIN | 1 | Oral | 0 | TABLET | ||||||||||
| 109946363 | 10994636 | 18 | C | ATORVASTATIN | ATORVASTATIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109946363 | 10994636 | 1 | Crohn's disease |
| 109946363 | 10994636 | 5 | Anticoagulant therapy |
| 109946363 | 10994636 | 6 | Thyroid disorder |
| 109946363 | 10994636 | 7 | Product used for unknown indication |
| 109946363 | 10994636 | 8 | Product used for unknown indication |
| 109946363 | 10994636 | 9 | Crohn's disease |
| 109946363 | 10994636 | 10 | Cardiac operation |
| 109946363 | 10994636 | 11 | Gastric disorder |
| 109946363 | 10994636 | 12 | Prophylaxis |
| 109946363 | 10994636 | 13 | Flatulence |
| 109946363 | 10994636 | 14 | Flatulence |
| 109946363 | 10994636 | 15 | Anaemia |
| 109946363 | 10994636 | 16 | Anaemia |
| 109946363 | 10994636 | 17 | Cardiac disorder |
| 109946363 | 10994636 | 18 | Blood cholesterol abnormal |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109946363 | 10994636 | OT |
| 109946363 | 10994636 | HO |
| 109946363 | 10994636 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109946363 | 10994636 | Anaemia | |
| 109946363 | 10994636 | Blood test abnormal | |
| 109946363 | 10994636 | Cardiac disorder | |
| 109946363 | 10994636 | Chest pain | |
| 109946363 | 10994636 | Constipation | |
| 109946363 | 10994636 | Coronary artery occlusion | |
| 109946363 | 10994636 | Crohn's disease | |
| 109946363 | 10994636 | Flatulence | |
| 109946363 | 10994636 | Gastric disorder | |
| 109946363 | 10994636 | Hypovitaminosis | |
| 109946363 | 10994636 | Intestinal obstruction | |
| 109946363 | 10994636 | Intestinal stenosis | |
| 109946363 | 10994636 | Limb discomfort | |
| 109946363 | 10994636 | Malnutrition | |
| 109946363 | 10994636 | Myocardial infarction | |
| 109946363 | 10994636 | Myocardial ischaemia | |
| 109946363 | 10994636 | Pain | |
| 109946363 | 10994636 | Tricuspid valve incompetence |
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 |
|---|---|---|---|---|---|---|
| 109946363 | 10994636 | 1 | 20140610 | 20140610 | 0 | |
| 109946363 | 10994636 | 2 | 2014 | 2014 | 0 | |
| 109946363 | 10994636 | 3 | 20150925 | 0 | ||
| 109946363 | 10994636 | 5 | 20141214 | 0 | ||
| 109946363 | 10994636 | 6 | 2013 | 0 | ||
| 109946363 | 10994636 | 10 | 20141204 | 0 | ||
| 109946363 | 10994636 | 11 | 201401 | 0 | ||
| 109946363 | 10994636 | 17 | 2015 | 0 |