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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116168323 | 11616832 | 3 | F | 200602 | 20160721 | 20151009 | 20160803 | EXP | US-BAYER-2015-434901 | BAYER | 46.00 | YR | A | F | Y | 62.58000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116168323 | 11616832 | 1 | PS | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 1 | 400 MG, UNK | 21085 | 400 | MG | FILM-COATED TABLET | ||||||||
| 116168323 | 11616832 | 2 | SS | AVELOX | MOXIFLOXACIN HYDROCHLORIDE | 1 | 400 MG, UNK | 21085 | 400 | MG | FILM-COATED TABLET | ||||||||
| 116168323 | 11616832 | 3 | SS | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 1 | 500 MG, UNK | 0 | 500 | MG | TABLET | ||||||||
| 116168323 | 11616832 | 4 | SS | CIPRO | CIPROFLOXACIN HYDROCHLORIDE | 1 | 500 MG, UNK | 0 | 500 | MG | TABLET | ||||||||
| 116168323 | 11616832 | 5 | C | LORAZEPAM. | LORAZEPAM | 1 | 5 MG, TID | 0 | 5 | MG | TID | ||||||||
| 116168323 | 11616832 | 6 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | 25 MG, QD | 0 | 25 | MG | QD | ||||||||
| 116168323 | 11616832 | 7 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 20 MG, QD | 0 | 20 | MG | QD | ||||||||
| 116168323 | 11616832 | 8 | C | ATORVASTATIN | ATORVASTATIN | 1 | 20 MG, QD | 0 | 20 | MG | QD | ||||||||
| 116168323 | 11616832 | 9 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | TWO PUFFS AS NEEDED | 0 | |||||||||||
| 116168323 | 11616832 | 10 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | TWO PUFFS AS NEEDED | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116168323 | 11616832 | 1 | Sinusitis |
| 116168323 | 11616832 | 2 | Cystitis |
| 116168323 | 11616832 | 3 | Cystitis |
| 116168323 | 11616832 | 4 | Haematuria |
| 116168323 | 11616832 | 5 | Anxiety |
| 116168323 | 11616832 | 6 | Depression |
| 116168323 | 11616832 | 7 | Gastrooesophageal reflux disease |
| 116168323 | 11616832 | 8 | Blood cholesterol increased |
| 116168323 | 11616832 | 9 | Asthma |
| 116168323 | 11616832 | 10 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116168323 | 11616832 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116168323 | 11616832 | Anxiety | |
| 116168323 | 11616832 | Cardiovascular disorder | |
| 116168323 | 11616832 | Emotional distress | |
| 116168323 | 11616832 | Injury | |
| 116168323 | 11616832 | Mental disorder | |
| 116168323 | 11616832 | Musculoskeletal injury | |
| 116168323 | 11616832 | Nervous system disorder | |
| 116168323 | 11616832 | Neuropathy peripheral | |
| 116168323 | 11616832 | Pain | |
| 116168323 | 11616832 | Skin disorder |
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 |
|---|---|---|---|---|---|---|
| 116168323 | 11616832 | 1 | 20060105 | 20060115 | 0 | |
| 116168323 | 11616832 | 2 | 20160316 | 20160323 | 0 | |
| 116168323 | 11616832 | 3 | 20150302 | 20150309 | 0 | |
| 116168323 | 11616832 | 4 | 20150506 | 0 |