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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116170043 | 11617004 | 3 | F | 200804 | 20160721 | 20151009 | 20160804 | EXP | US-BAYER-2015-435173 | BAYER | 60.58 | YR | F | Y | 117.90000 | KG | 20160804 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116170043 | 11617004 | 1 | PS | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 1 | UNK | 21085 | FILM-COATED TABLET | ||||||||||
| 116170043 | 11617004 | 2 | SS | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 1 | UNK | 21085 | FILM-COATED TABLET | ||||||||||
| 116170043 | 11617004 | 3 | SS | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 1 | 400 MG, UNK | 21085 | 400 | MG | FILM-COATED TABLET | ||||||||
| 116170043 | 11617004 | 4 | SS | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 1 | 400 MG, UNK | 21085 | 400 | MG | FILM-COATED TABLET | ||||||||
| 116170043 | 11617004 | 5 | SS | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | 500 MG, UNK | 0 | 500 | MG | |||||||||
| 116170043 | 11617004 | 6 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | 75 MG, QD | 0 | 75 | MG | QD | ||||||||
| 116170043 | 11617004 | 7 | C | METOPROLOL. | METOPROLOL | 1 | 50 MG, QD | 0 | 50 | MG | QD | ||||||||
| 116170043 | 11617004 | 8 | C | METOPROLOL. | METOPROLOL | 1 | UNK | 0 | |||||||||||
| 116170043 | 11617004 | 9 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | 137 MCG/24HR, QD | 0 | QD | ||||||||||
| 116170043 | 11617004 | 10 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | UNK | 0 | |||||||||||
| 116170043 | 11617004 | 11 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 20 MG, QD | 0 | 20 | MG | QD | ||||||||
| 116170043 | 11617004 | 12 | C | SIMVASTATIN. | SIMVASTATIN | 1 | UNK | 0 | |||||||||||
| 116170043 | 11617004 | 13 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | 50 MG, QD | 0 | 50 | MG | QD | ||||||||
| 116170043 | 11617004 | 14 | C | DULOXETINE. | DULOXETINE | 1 | 30 MG, QD | 0 | 30 | MG | QD | ||||||||
| 116170043 | 11617004 | 15 | C | DULOXETINE. | DULOXETINE | 1 | 0 | ||||||||||||
| 116170043 | 11617004 | 16 | C | OXYBUTYNIN | OXYBUTYNIN | 1 | 10 MG, UNK | 0 | 10 | MG | |||||||||
| 116170043 | 11617004 | 17 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | UNK | 0 | |||||||||||
| 116170043 | 11617004 | 18 | C | LOSARTAN. | LOSARTAN | 1 | UNK | 0 | |||||||||||
| 116170043 | 11617004 | 19 | C | AMOXICILLIN. | AMOXICILLIN | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116170043 | 11617004 | 1 | Bronchitis |
| 116170043 | 11617004 | 2 | Bronchitis |
| 116170043 | 11617004 | 3 | Bronchitis |
| 116170043 | 11617004 | 4 | Bronchitis |
| 116170043 | 11617004 | 5 | Urinary tract infection |
| 116170043 | 11617004 | 6 | Transient ischaemic attack |
| 116170043 | 11617004 | 7 | Hypertension |
| 116170043 | 11617004 | 8 | Hypertension |
| 116170043 | 11617004 | 9 | Hypothyroidism |
| 116170043 | 11617004 | 10 | Hypothyroidism |
| 116170043 | 11617004 | 11 | Blood cholesterol increased |
| 116170043 | 11617004 | 12 | Transient ischaemic attack |
| 116170043 | 11617004 | 13 | Panic attack |
| 116170043 | 11617004 | 14 | Antidepressant drug level |
| 116170043 | 11617004 | 15 | Neuralgia |
| 116170043 | 11617004 | 16 | Hypertonic bladder |
| 116170043 | 11617004 | 17 | Arthralgia |
| 116170043 | 11617004 | 19 | Infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116170043 | 11617004 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116170043 | 11617004 | Anxiety | |
| 116170043 | 11617004 | Cardiovascular disorder | |
| 116170043 | 11617004 | Dizziness | |
| 116170043 | 11617004 | Emotional distress | |
| 116170043 | 11617004 | Injury | |
| 116170043 | 11617004 | Mental disorder | |
| 116170043 | 11617004 | Musculoskeletal injury | |
| 116170043 | 11617004 | Nervous system disorder | |
| 116170043 | 11617004 | Neuropathy peripheral | |
| 116170043 | 11617004 | Occipital neuralgia | |
| 116170043 | 11617004 | Pain | |
| 116170043 | 11617004 | Skin injury |
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 |
|---|---|---|---|---|---|---|
| 116170043 | 11617004 | 1 | 200801 | 0 | ||
| 116170043 | 11617004 | 2 | 200802 | 0 | ||
| 116170043 | 11617004 | 3 | 20080105 | 20080112 | 0 | |
| 116170043 | 11617004 | 4 | 20080228 | 0 | ||
| 116170043 | 11617004 | 5 | 20091201 | 20091211 | 0 | |
| 116170043 | 11617004 | 8 | 200801 | 2015 | 0 | |
| 116170043 | 11617004 | 10 | 2011 | 2015 | 0 | |
| 116170043 | 11617004 | 12 | 201205 | 0 | ||
| 116170043 | 11617004 | 17 | 20160419 | 0 | ||
| 116170043 | 11617004 | 19 | 20131203 | 0 |