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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120158966 | 12015896 | 6 | F | 2015 | 20160826 | 20160205 | 20160912 | PER | US-ASTRAZENECA-2016SE00706 | ASTRAZENECA | 69.00 | YR | M | Y | 88.50000 | KG | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120158966 | 12015896 | 1 | PS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5MCG, TWO PUFFS TWICE A DAY | 3001078C00,3001105C00,3001158C00 | 21929 | |||||||||
| 120158966 | 12015896 | 2 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5MCG, TWO PUFFS TWICE A DAY | 3001078C00,3001105C00,3001158C00 | 21929 | |||||||||
| 120158966 | 12015896 | 3 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5MCG, TWO PUFFS TWICE A DAY | 21929 | ||||||||||
| 120158966 | 12015896 | 4 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5MCG, TWO PUFFS TWICE A DAY | 21929 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120158966 | 12015896 | 1 | Chronic obstructive pulmonary disease |
| 120158966 | 12015896 | 2 | Dyspnoea |
| 120158966 | 12015896 | 3 | Chronic obstructive pulmonary disease |
| 120158966 | 12015896 | 4 | Dyspnoea |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120158966 | 12015896 | Back disorder | |
| 120158966 | 12015896 | Chronic obstructive pulmonary disease | |
| 120158966 | 12015896 | Condition aggravated | |
| 120158966 | 12015896 | Device malfunction | |
| 120158966 | 12015896 | Drug dose omission | |
| 120158966 | 12015896 | Drug effect delayed | |
| 120158966 | 12015896 | Drug ineffective | |
| 120158966 | 12015896 | Dyspnoea | |
| 120158966 | 12015896 | Intentional device misuse |
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 |
|---|---|---|---|---|---|---|
| 120158966 | 12015896 | 1 | 2014 | 0 | ||
| 120158966 | 12015896 | 2 | 2014 | 0 | ||
| 120158966 | 12015896 | 3 | 2015 | 0 | ||
| 120158966 | 12015896 | 4 | 2015 | 0 |