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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126597092 | 12659709 | 2 | F | 2015 | 20160913 | 20160817 | 20160919 | EXP | US-ABBVIE-16K-163-1670770-00 | ABBVIE | 0.00 | F | Y | 90.80000 | KG | 20160919 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126597092 | 12659709 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | INDUCTION DOSE | 1052446 | 125057 | 160 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | ||||||
| 126597092 | 12659709 | 2 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | TWO WEEKS AFTER 160 MG DOSE | 1052446 | 125057 | 80 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | ||||||
| 126597092 | 12659709 | 3 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | FOUR WEEKS AFTER 160 MG DOSE | 1052446 | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 126597092 | 12659709 | 4 | SS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | Y | UNKNOWN | 0 | |||||||||
| 126597092 | 12659709 | 5 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | 0 | ||||||||||||
| 126597092 | 12659709 | 6 | C | VALSARTAN. | VALSARTAN | 1 | 0 | 320 | MG | QD | |||||||||
| 126597092 | 12659709 | 7 | C | FUROSEMIDE. | FUROSEMIDE | 1 | 0 | ||||||||||||
| 126597092 | 12659709 | 8 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Oral | 0 | .25 | MG | |||||||||
| 126597092 | 12659709 | 9 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 0 | 10 | MG | QD | |||||||||
| 126597092 | 12659709 | 10 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 0 | 1000 | MG | |||||||||
| 126597092 | 12659709 | 11 | C | TIZANIDINE. | TIZANIDINE | 1 | 0 | 2 | MG | TID | |||||||||
| 126597092 | 12659709 | 12 | C | LASIX | FUROSEMIDE | 1 | 0 | 20 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126597092 | 12659709 | 1 | Crohn's disease |
| 126597092 | 12659709 | 4 | Depression |
| 126597092 | 12659709 | 5 | Gastrooesophageal reflux disease |
| 126597092 | 12659709 | 6 | Hypertension |
| 126597092 | 12659709 | 7 | Fluid retention |
| 126597092 | 12659709 | 8 | Anxiety |
| 126597092 | 12659709 | 9 | Hypertension |
| 126597092 | 12659709 | 10 | Hypovitaminosis |
| 126597092 | 12659709 | 11 | Product used for unknown indication |
| 126597092 | 12659709 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126597092 | 12659709 | OT |
| 126597092 | 12659709 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126597092 | 12659709 | Ankle fracture | |
| 126597092 | 12659709 | Balance disorder | |
| 126597092 | 12659709 | Blood sodium decreased | |
| 126597092 | 12659709 | Dizziness | |
| 126597092 | 12659709 | Eye disorder | |
| 126597092 | 12659709 | Face injury | |
| 126597092 | 12659709 | Fall | |
| 126597092 | 12659709 | Foot fracture | |
| 126597092 | 12659709 | Hypoaesthesia | |
| 126597092 | 12659709 | Loss of consciousness | |
| 126597092 | 12659709 | Lower limb fracture | |
| 126597092 | 12659709 | Muscle spasms | |
| 126597092 | 12659709 | Paraesthesia | |
| 126597092 | 12659709 | Psoriasis | |
| 126597092 | 12659709 | Spinal fracture | |
| 126597092 | 12659709 | Spinal osteoarthritis |
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 |
|---|---|---|---|---|---|---|
| 126597092 | 12659709 | 1 | 2014 | 2014 | 0 | |
| 126597092 | 12659709 | 3 | 20150206 | 20160705 | 0 |