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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125670011 | 12567001 | 1 | I | 201604 | 20160620 | 20160718 | 20160718 | EXP | US-ABBVIE-16K-163-1658192-00 | ABBVIE | 59.67 | YR | F | Y | 56.75000 | KG | 20160718 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125670011 | 12567001 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 125057 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||
| 125670011 | 12567001 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | ||||
| 125670011 | 12567001 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | U | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | ||||
| 125670011 | 12567001 | 4 | SS | VANCOMYCIN | VANCOMYCIN | 1 | Oral | UNKNOWN | 0 | TABLET | |||||||||
| 125670011 | 12567001 | 5 | C | PREDNISONE. | PREDNISONE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125670011 | 12567001 | 1 | Rheumatoid arthritis |
| 125670011 | 12567001 | 4 | Clostridium difficile infection |
| 125670011 | 12567001 | 5 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125670011 | 12567001 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125670011 | 12567001 | Blood pressure decreased | |
| 125670011 | 12567001 | Blood pressure increased | |
| 125670011 | 12567001 | Clostridium difficile infection | |
| 125670011 | 12567001 | Colitis | |
| 125670011 | 12567001 | Cough | |
| 125670011 | 12567001 | Dehydration | |
| 125670011 | 12567001 | Diverticulitis | |
| 125670011 | 12567001 | Drug hypersensitivity | |
| 125670011 | 12567001 | Dyspnoea | |
| 125670011 | 12567001 | Fluid retention | |
| 125670011 | 12567001 | Gastrointestinal wall thickening | |
| 125670011 | 12567001 | Leukocytosis | |
| 125670011 | 12567001 | Open globe injury | |
| 125670011 | 12567001 | Upper respiratory tract infection | |
| 125670011 | 12567001 | Urticaria | |
| 125670011 | 12567001 | Vitreous floaters | |
| 125670011 | 12567001 | 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 |
|---|---|---|---|---|---|---|
| 125670011 | 12567001 | 1 | 2016 | 0 | ||
| 125670011 | 12567001 | 3 | 201605 | 201605 | 0 |