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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115043675 | 11504367 | 5 | F | 2013 | 20160916 | 20150915 | 20160922 | EXP | BR-ABBVIE-15K-020-1463136-00 | ABBVIE | 0.00 | M | Y | 58.00000 | KG | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115043675 | 11504367 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | 414953XH01 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 115043675 | 11504367 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | 414953XH01 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 115043675 | 11504367 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | 414953XH01 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 115043675 | 11504367 | 4 | C | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | 0 | 1.5 | G | TABLET | TID | |||||||
| 115043675 | 11504367 | 5 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Oral | 0 | TABLET | ||||||||||
| 115043675 | 11504367 | 6 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | 0 | ||||||||||||
| 115043675 | 11504367 | 7 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Oral | 0 | ORAL DROPS | ||||||||||
| 115043675 | 11504367 | 8 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | TABLET | ||||||||||
| 115043675 | 11504367 | 9 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 115043675 | 11504367 | 10 | C | SULFASALAZINE. | SULFASALAZINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115043675 | 11504367 | 1 | Ankylosing spondylitis |
| 115043675 | 11504367 | 4 | Ankylosing spondylitis |
| 115043675 | 11504367 | 5 | Anxiety |
| 115043675 | 11504367 | 6 | Depression |
| 115043675 | 11504367 | 7 | Spondylitis |
| 115043675 | 11504367 | 8 | Gastric disorder |
| 115043675 | 11504367 | 9 | Prophylaxis |
| 115043675 | 11504367 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115043675 | 11504367 | HO |
| 115043675 | 11504367 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115043675 | 11504367 | Hypovitaminosis | |
| 115043675 | 11504367 | Impaired gastric emptying | |
| 115043675 | 11504367 | Intestinal obstruction | |
| 115043675 | 11504367 | Intestinal stenosis | |
| 115043675 | 11504367 | Mineral deficiency | |
| 115043675 | 11504367 | Muscle spasms | |
| 115043675 | 11504367 | Shock hypoglycaemic | |
| 115043675 | 11504367 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 115043675 | 11504367 | 1 | 20130202 | 0 | ||
| 115043675 | 11504367 | 2 | 2013 | 0 | ||
| 115043675 | 11504367 | 4 | 2012 | 0 | ||
| 115043675 | 11504367 | 5 | 2010 | 0 | ||
| 115043675 | 11504367 | 7 | 2012 | 0 | ||
| 115043675 | 11504367 | 8 | 2006 | 0 |