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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104285493 | 10428549 | 3 | F | 2012 | 20160908 | 20140903 | 20160919 | EXP | CA-ABBVIE-14K-028-1278091-00 | ABBVIE | 75.23 | YR | M | Y | 0.00000 | 20160919 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104285493 | 10428549 | 1 | PS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | Y | UNKNOWN | 125057 | 40 | MG | SOLUTION FOR INJECTION IN PRE-FILLED PEN | QOW | |||||
| 104285493 | 10428549 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | Y | UNKNOWN | 0 | 15 | MG | /wk | ||||||
| 104285493 | 10428549 | 3 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | 5 | MG | QD | ||||||||
| 104285493 | 10428549 | 4 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | EVERY 8 HOURS | 0 | 650 | MG | ||||||||
| 104285493 | 10428549 | 5 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 104285493 | 10428549 | 6 | C | GRAVOL | DIMENHYDRINATE | 1 | 0 | ||||||||||||
| 104285493 | 10428549 | 7 | C | ZOPICLONE | ZOPICLONE | 1 | AT BED TIME | 0 | 5 | MG | |||||||||
| 104285493 | 10428549 | 8 | C | HEPARIN | HEPARIN SODIUM | 1 | Subcutaneous | AT BED TIME | 0 | 500 | DF | TID | |||||||
| 104285493 | 10428549 | 9 | C | TAMSULOSIN | TAMSULOSIN | 1 | 0 | .4 | MG | QD | |||||||||
| 104285493 | 10428549 | 10 | C | AVODART | DUTASTERIDE | 1 | 0 | .5 | MG | QD | |||||||||
| 104285493 | 10428549 | 11 | C | TEMAZEPAM. | TEMAZEPAM | 1 | AT BEDTIME | 0 | QD | ||||||||||
| 104285493 | 10428549 | 12 | C | METOPROLOL. | METOPROLOL | 1 | 0 | 50 | MG | BID | |||||||||
| 104285493 | 10428549 | 13 | C | FERROUS FUMARATE | FERROUS FUMARATE | 1 | EVERY MORNING | 0 | 300 | MG | QD | ||||||||
| 104285493 | 10428549 | 14 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | Oral | EVERY MORNING | 0 | 500 | MG | QD | |||||||
| 104285493 | 10428549 | 15 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | Oral | EVERY MORNING | 0 | 500 | MG | TID | |||||||
| 104285493 | 10428549 | 16 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Oral | 0 | 1000 | DF | QD | ||||||||
| 104285493 | 10428549 | 17 | C | DUTASTERIDE. | DUTASTERIDE | 1 | 0 | ||||||||||||
| 104285493 | 10428549 | 18 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | 0 | 50 | MG | TID | |||||||||
| 104285493 | 10428549 | 19 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 0 | 10 | MG | QD | |||||||||
| 104285493 | 10428549 | 20 | C | STEROIDS | UNSPECIFIED INGREDIENT | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104285493 | 10428549 | 1 | Product used for unknown indication |
| 104285493 | 10428549 | 2 | Crohn's disease |
| 104285493 | 10428549 | 3 | Crohn's disease |
| 104285493 | 10428549 | 4 | Pain |
| 104285493 | 10428549 | 5 | Pyrexia |
| 104285493 | 10428549 | 6 | Product used for unknown indication |
| 104285493 | 10428549 | 7 | Product used for unknown indication |
| 104285493 | 10428549 | 8 | Product used for unknown indication |
| 104285493 | 10428549 | 9 | Product used for unknown indication |
| 104285493 | 10428549 | 10 | Product used for unknown indication |
| 104285493 | 10428549 | 11 | Product used for unknown indication |
| 104285493 | 10428549 | 12 | Product used for unknown indication |
| 104285493 | 10428549 | 13 | Product used for unknown indication |
| 104285493 | 10428549 | 14 | Product used for unknown indication |
| 104285493 | 10428549 | 16 | Product used for unknown indication |
| 104285493 | 10428549 | 17 | Product used for unknown indication |
| 104285493 | 10428549 | 18 | Product used for unknown indication |
| 104285493 | 10428549 | 19 | Product used for unknown indication |
| 104285493 | 10428549 | 20 | Crohn's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104285493 | 10428549 | OT |
| 104285493 | 10428549 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104285493 | 10428549 | Acute kidney injury | |
| 104285493 | 10428549 | Arthralgia | |
| 104285493 | 10428549 | Blood albumin decreased | |
| 104285493 | 10428549 | Blood potassium decreased | |
| 104285493 | 10428549 | Calcification of muscle | |
| 104285493 | 10428549 | Chills | |
| 104285493 | 10428549 | Cough | |
| 104285493 | 10428549 | Dry mouth | |
| 104285493 | 10428549 | Haemoglobin decreased | |
| 104285493 | 10428549 | Hypersensitivity | |
| 104285493 | 10428549 | Hypophagia | |
| 104285493 | 10428549 | Influenza like illness | |
| 104285493 | 10428549 | Intervertebral disc protrusion | |
| 104285493 | 10428549 | Lung infiltration | |
| 104285493 | 10428549 | Muscle haemorrhage | |
| 104285493 | 10428549 | Myalgia | |
| 104285493 | 10428549 | Nephritis | |
| 104285493 | 10428549 | Pleural effusion | |
| 104285493 | 10428549 | Pneumonia | |
| 104285493 | 10428549 | Psoas abscess | |
| 104285493 | 10428549 | Pyrexia | |
| 104285493 | 10428549 | Staphylococcal bacteraemia | |
| 104285493 | 10428549 | Thrombocytopenia | |
| 104285493 | 10428549 | Tubulointerstitial nephritis | |
| 104285493 | 10428549 | Urinary retention |
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 |
|---|---|---|---|---|---|---|
| 104285493 | 10428549 | 1 | 20120725 | 20140716 | 0 | |
| 104285493 | 10428549 | 2 | 20120604 | 20140716 | 0 | |
| 104285493 | 10428549 | 3 | 20140604 | 201408 | 0 | |
| 104285493 | 10428549 | 4 | 201407 | 0 | ||
| 104285493 | 10428549 | 8 | 201408 | 0 | ||
| 104285493 | 10428549 | 12 | 201408 | 0 | ||
| 104285493 | 10428549 | 14 | 201408 | 0 | ||
| 104285493 | 10428549 | 15 | 201408 | 0 | ||
| 104285493 | 10428549 | 18 | 201408 | 0 | ||
| 104285493 | 10428549 | 19 | 201408 | 0 |