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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125944561 | 12594456 | 1 | I | 201311 | 20160718 | 20160726 | 20160726 | EXP | BG-ASTRAZENECA-2016SE79407 | ASTRAZENECA | 0.00 | M | Y | 0.00000 | 20160726 | MD | BG | BG |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125944561 | 12594456 | 1 | PS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 2X1 INHALATIONS DAILY | 21929 | INHALATION POWDER | BID | ||||||||
| 125944561 | 12594456 | 2 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG 2X2 INHALATIONS DAILY | 21929 | INHALATION POWDER | BID | ||||||||
| 125944561 | 12594456 | 3 | C | SALBUTAMOL | ALBUTEROL | 1 | 2 INHALATIONS (ON DEMAND) | 0 | |||||||||||
| 125944561 | 12594456 | 4 | C | TIOTROPIUM | TIOTROPIUM | 1 | 18 MCG X1 INHALATION DAILY | 0 | |||||||||||
| 125944561 | 12594456 | 5 | C | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | 2X1 INHALATION DAILY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125944561 | 12594456 | 1 | Chronic obstructive pulmonary disease |
| 125944561 | 12594456 | 2 | Chronic obstructive pulmonary disease |
| 125944561 | 12594456 | 3 | Chronic obstructive pulmonary disease |
| 125944561 | 12594456 | 4 | Chronic obstructive pulmonary disease |
| 125944561 | 12594456 | 5 | Chronic obstructive pulmonary disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125944561 | 12594456 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125944561 | 12594456 | Chronic obstructive pulmonary disease | |
| 125944561 | 12594456 | Dyspnoea | |
| 125944561 | 12594456 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 125944561 | 12594456 | 1 | 201005 | 201311 | 0 | |
| 125944561 | 12594456 | 2 | 201311 | 0 | ||
| 125944561 | 12594456 | 3 | 200812 | 0 | ||
| 125944561 | 12594456 | 4 | 201112 | 0 | ||
| 125944561 | 12594456 | 5 | 200812 | 0 |