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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126570832 | 12657083 | 2 | F | 20160730 | 20160908 | 20160816 | 20160915 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-52497BP | BOEHRINGER INGELHEIM | 75.35 | YR | F | Y | 79.00000 | KG | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126570832 | 12657083 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | 504145A | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | |||||
| 126570832 | 12657083 | 2 | SS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | 504145A | 21395 | |||||||||||
| 126570832 | 12657083 | 3 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 162.5 MG | 0 | 325 | MG | TABLET | |||||||
| 126570832 | 12657083 | 4 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 60 MG | 0 | 60 | MG | CAPSULE | QD | ||||||
| 126570832 | 12657083 | 5 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | Nasal | 100 MCG | 0 | 50 | UG | BID | |||||||
| 126570832 | 12657083 | 6 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | 50 MG | 0 | 50 | MG | TABLET | QD | ||||||
| 126570832 | 12657083 | 7 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Oral | 40 MG | 0 | 40 | MG | TABLET | QD | ||||||
| 126570832 | 12657083 | 8 | C | PROTONIX | PANTOPRAZOLE SODIUM | 1 | Oral | 40 MG | 0 | 40 | MG | TABLET | QD | ||||||
| 126570832 | 12657083 | 9 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | 0 | |||||||||||
| 126570832 | 12657083 | 10 | C | GLIPIZIDE XL | GLIPIZIDE | 1 | Oral | 10 MG | 0 | 10 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126570832 | 12657083 | 1 | Chronic obstructive pulmonary disease |
| 126570832 | 12657083 | 2 | Bronchitis chronic |
| 126570832 | 12657083 | 3 | Product used for unknown indication |
| 126570832 | 12657083 | 4 | Depression |
| 126570832 | 12657083 | 5 | Seasonal allergy |
| 126570832 | 12657083 | 6 | Mood swings |
| 126570832 | 12657083 | 7 | Blood cholesterol increased |
| 126570832 | 12657083 | 8 | Gastrooesophageal reflux disease |
| 126570832 | 12657083 | 9 | Asthma |
| 126570832 | 12657083 | 10 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126570832 | 12657083 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126570832 | 12657083 | Asthma | |
| 126570832 | 12657083 | Atrial fibrillation | |
| 126570832 | 12657083 | Drug hypersensitivity | |
| 126570832 | 12657083 | Loss of consciousness | |
| 126570832 | 12657083 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 126570832 | 12657083 | 1 | 2013 | 0 | ||
| 126570832 | 12657083 | 4 | 2014 | 0 | ||
| 126570832 | 12657083 | 5 | 2013 | 0 | ||
| 126570832 | 12657083 | 6 | 201606 | 0 | ||
| 126570832 | 12657083 | 7 | 2013 | 0 | ||
| 126570832 | 12657083 | 8 | 2013 | 0 | ||
| 126570832 | 12657083 | 9 | 2013 | 201608 | 0 | |
| 126570832 | 12657083 | 10 | 2013 | 201608 | 0 |