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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113659183 | 11365918 | 3 | F | 20160717 | 20160803 | 20150811 | 20160816 | EXP | US-BAYER-2015-390071 | BAYER | 66.00 | YR | E | M | Y | 91.61000 | KG | 20160816 | MD | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113659183 | 11365918 | 1 | PS | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 1 | 400 MG, UNK | 21085 | 400 | MG | FILM-COATED TABLET | ||||||||
| 113659183 | 11365918 | 2 | SS | LEVAQUIN | LEVOFLOXACIN | 1 | 500 MG, UNK | 0 | 500 | MG | |||||||||
| 113659183 | 11365918 | 3 | SS | LEVAQUIN | LEVOFLOXACIN | 1 | 0 | ||||||||||||
| 113659183 | 11365918 | 4 | SS | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | 500 MG, UNK | 0 | 500 | MG | |||||||||
| 113659183 | 11365918 | 5 | C | BENICAR | OLMESARTAN MEDOXOMIL | 1 | 40 MG, QD | 0 | 40 | MG | QD | ||||||||
| 113659183 | 11365918 | 6 | C | SILDENAFIL. | SILDENAFIL | 1 | 100 MG, QD | 0 | 100 | MG | QD | ||||||||
| 113659183 | 11365918 | 7 | C | ASPIRIN. | ASPIRIN | 1 | 325 MG, QD | 0 | 325 | MG | QD | ||||||||
| 113659183 | 11365918 | 8 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | 1000 MG, BID | 0 | 1000 | MG | BID | ||||||||
| 113659183 | 11365918 | 9 | C | ARMODAFINIL. | ARMODAFINIL | 1 | 50 MG, QD | 0 | 50 | MG | QD | ||||||||
| 113659183 | 11365918 | 10 | C | ALLOPURINOL. | ALLOPURINOL | 1 | 100 MG, BID | 0 | 100 | MG | BID | ||||||||
| 113659183 | 11365918 | 11 | C | VITAMIN C | ASCORBIC ACID | 1 | 1000 MG, QD | 0 | 1000 | MG | QD | ||||||||
| 113659183 | 11365918 | 12 | C | CARVEDILOL. | CARVEDILOL | 1 | 3.125 MG, BID | 0 | 3.125 | MG | BID | ||||||||
| 113659183 | 11365918 | 13 | C | CETIRIZIN | CETIRIZINE HYDROCHLORIDE | 1 | 10 MG, QD | 0 | 10 | MG | QD | ||||||||
| 113659183 | 11365918 | 14 | C | FENTANYL. | FENTANYL | 1 | 100 MCG/24HR, QOD | 0 | QOD | ||||||||||
| 113659183 | 11365918 | 15 | C | MULTIVITAMINS W/MINERALS | MINERALSVITAMINS | 1 | Oral | UNK | 0 | ||||||||||
| 113659183 | 11365918 | 16 | C | OMEGA-6 FATTY ACIDS | OMEGA-6 FATTY ACIDS | 1 | 1000 MG, BID | 0 | 1000 | MG | BID | ||||||||
| 113659183 | 11365918 | 17 | C | OXYCODONE | OXYCODONE | 1 | 10 MG, BID | 0 | 10 | MG | BID | ||||||||
| 113659183 | 11365918 | 18 | C | POLYETHYL. GLYC. W/POTAS. CHLOR./SOD. BICARB. | 2 | UNK UNK, PRN | 0 | ||||||||||||
| 113659183 | 11365918 | 19 | C | POTASSIUM CITRATE. | POTASSIUM CITRATE | 1 | 180 MG, QD | 0 | 180 | MG | QD | ||||||||
| 113659183 | 11365918 | 20 | C | VITAMIN D [COLECALCIFEROL] | 2 | 4000 IU, QD | 0 | 4000 | IU | QD | |||||||||
| 113659183 | 11365918 | 21 | C | AMOXICILLIN. | AMOXICILLIN | 1 | UNK | 0 | |||||||||||
| 113659183 | 11365918 | 22 | C | PREDNISONE. | PREDNISONE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113659183 | 11365918 | 1 | Sinusitis |
| 113659183 | 11365918 | 2 | Prostatitis |
| 113659183 | 11365918 | 3 | Benign prostatic hyperplasia |
| 113659183 | 11365918 | 4 | Sinusitis |
| 113659183 | 11365918 | 5 | Hypertension |
| 113659183 | 11365918 | 6 | Erectile dysfunction |
| 113659183 | 11365918 | 7 | Inflammatory pain |
| 113659183 | 11365918 | 8 | Type 2 diabetes mellitus |
| 113659183 | 11365918 | 10 | Blood uric acid increased |
| 113659183 | 11365918 | 11 | General physical health deterioration |
| 113659183 | 11365918 | 12 | Hypertension |
| 113659183 | 11365918 | 13 | Multiple allergies |
| 113659183 | 11365918 | 14 | Drug hypersensitivity |
| 113659183 | 11365918 | 15 | General physical health deterioration |
| 113659183 | 11365918 | 17 | Back pain |
| 113659183 | 11365918 | 18 | Endoscopy |
| 113659183 | 11365918 | 19 | Nephrolithiasis |
| 113659183 | 11365918 | 20 | Hypovitaminosis |
| 113659183 | 11365918 | 21 | Sinus disorder |
| 113659183 | 11365918 | 22 | Neuralgia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113659183 | 11365918 | DS |
| 113659183 | 11365918 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113659183 | 11365918 | Back pain | |
| 113659183 | 11365918 | Balance disorder | |
| 113659183 | 11365918 | Depression | |
| 113659183 | 11365918 | Economic problem | |
| 113659183 | 11365918 | Emotional distress | |
| 113659183 | 11365918 | Facial bones fracture | |
| 113659183 | 11365918 | Fall | |
| 113659183 | 11365918 | Gait disturbance | |
| 113659183 | 11365918 | Hypoaesthesia | |
| 113659183 | 11365918 | Injury | |
| 113659183 | 11365918 | Neuropathy peripheral | |
| 113659183 | 11365918 | Pain |
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 |
|---|---|---|---|---|---|---|
| 113659183 | 11365918 | 1 | 20091010 | 20091017 | 0 | |
| 113659183 | 11365918 | 2 | 201010 | 0 | ||
| 113659183 | 11365918 | 4 | 20110518 | 20110528 | 0 | |
| 113659183 | 11365918 | 5 | 2006 | 0 | ||
| 113659183 | 11365918 | 7 | 2010 | 0 | ||
| 113659183 | 11365918 | 8 | 2010 | 2015 | 0 | |
| 113659183 | 11365918 | 12 | 2006 | 0 | ||
| 113659183 | 11365918 | 14 | 2008 | 0 | ||
| 113659183 | 11365918 | 21 | 2010 | 0 | ||
| 113659183 | 11365918 | 22 | 2010 | 0 |