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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121698185 | 12169818 | 5 | F | 2016 | 20160906 | 20160310 | 20160913 | EXP | CA-ABBVIE-16K-028-1571165-00 | ABBVIE | 76.41 | YR | F | Y | 0.00000 | 20160913 | OT | COUNTRY NOT SPECIFIED | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121698185 | 12169818 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 58122XD07 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | QOW | |||||
| 121698185 | 12169818 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | LOADING DOSE | Y | 58122XD07 | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||
| 121698185 | 12169818 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | 58122XD07 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 121698185 | 12169818 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Oral | TAPERING DOWN | 0 | TABLET | |||||||||
| 121698185 | 12169818 | 5 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 121698185 | 12169818 | 6 | C | GLICLAZIDE | GLICLAZIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121698185 | 12169818 | 1 | Crohn's disease |
| 121698185 | 12169818 | 4 | Product used for unknown indication |
| 121698185 | 12169818 | 5 | Diabetes mellitus |
| 121698185 | 12169818 | 6 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121698185 | 12169818 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121698185 | 12169818 | Asthenia | |
| 121698185 | 12169818 | Blood glucose increased | |
| 121698185 | 12169818 | Constipation | |
| 121698185 | 12169818 | Decreased appetite | |
| 121698185 | 12169818 | Diarrhoea | |
| 121698185 | 12169818 | Faeces hard | |
| 121698185 | 12169818 | Frequent bowel movements | |
| 121698185 | 12169818 | Headache | |
| 121698185 | 12169818 | Incontinence | |
| 121698185 | 12169818 | Injection site pain | |
| 121698185 | 12169818 | Malaise | |
| 121698185 | 12169818 | Nausea | |
| 121698185 | 12169818 | Pallor | |
| 121698185 | 12169818 | Vomiting | |
| 121698185 | 12169818 | 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 |
|---|---|---|---|---|---|---|
| 121698185 | 12169818 | 1 | 20160204 | 20160218 | 0 | |
| 121698185 | 12169818 | 2 | 20160305 | 20160305 | 0 | |
| 121698185 | 12169818 | 3 | 201603 | 0 |