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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120107372 | 12010737 | 2 | F | 20160611 | 20160205 | 20160811 | PER | US-ASTRAZENECA-2016SE08769 | ASTRAZENECA | 0.00 | F | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120107372 | 12010737 | 1 | PS | TUDORZA PRESSAIR | ACLIDINIUM BROMIDE | 1 | Respiratory (inhalation) | 1146241 | 202450 | 400 | UG | INHALATION POWDER | BID | ||||||
| 120107372 | 12010737 | 2 | SS | TUDORZA PRESSAIR | ACLIDINIUM BROMIDE | 1 | Respiratory (inhalation) | 1146241 | 202450 | 400 | UG | INHALATION POWDER | BID | ||||||
| 120107372 | 12010737 | 3 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 2 INHALATIONS TWO TIMES A DAY | 0 | BID | |||||||||
| 120107372 | 12010737 | 4 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 2 INHALATIONS TWO TIMES A DAY | 0 | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120107372 | 12010737 | 1 | Chronic obstructive pulmonary disease |
| 120107372 | 12010737 | 2 | Emphysema |
| 120107372 | 12010737 | 3 | Chronic obstructive pulmonary disease |
| 120107372 | 12010737 | 4 | Emphysema |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120107372 | 12010737 | Device failure | |
| 120107372 | 12010737 | Device malfunction | |
| 120107372 | 12010737 | Drug dose omission | |
| 120107372 | 12010737 | Malaise | |
| 120107372 | 12010737 | Upper respiratory tract infection |
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 |
|---|---|---|---|---|---|---|
| 120107372 | 12010737 | 1 | 2014 | 0 | ||
| 120107372 | 12010737 | 2 | 2014 | 0 | ||
| 120107372 | 12010737 | 3 | 2013 | 0 | ||
| 120107372 | 12010737 | 4 | 2013 | 0 |