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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126190131 | 12619013 | 1 | I | 20160520 | 20160803 | 20160803 | PER | US-ASTRAZENECA-2016SE55907 | ASTRAZENECA | 0.00 | F | Y | 54.40000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126190131 | 12619013 | 1 | PS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 2 PUFFS TWICE A DAY | 3001100C00 | 21929 | BID | ||||||||
| 126190131 | 12619013 | 2 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 2 PUFFS TWICE A DAY | 3001100C00 | 21929 | BID | ||||||||
| 126190131 | 12619013 | 3 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 5 AND 10 MG ALTERNATELY, 5MG ONE DAY AND 10 MG THE NEXT DAY | 0 | ||||||||||
| 126190131 | 12619013 | 4 | C | DILTIAZEM. | DILTIAZEM | 1 | Oral | 0 | 30 | MG | TID | ||||||||
| 126190131 | 12619013 | 5 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 0 | 81 | MG | QD | ||||||||
| 126190131 | 12619013 | 6 | C | ZITHROMYCIN | AZITHROMYCIN ANHYDROUS | 1 | Oral | 0 | 250 | MG | QD | ||||||||
| 126190131 | 12619013 | 7 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 1 PUFF DAILY | 0 | ||||||||||
| 126190131 | 12619013 | 8 | C | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | Oral | 0 | 70 | MG | /wk | ||||||||
| 126190131 | 12619013 | 9 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | Oral | 0 | 10 | MG | QD | ||||||||
| 126190131 | 12619013 | 10 | C | CITRACAL PLUS D3 | 2 | Oral | 0 | ||||||||||||
| 126190131 | 12619013 | 11 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 1000 UI | 0 | ||||||||||
| 126190131 | 12619013 | 12 | C | CENTRUM SILVER | MINERALSVITAMINS | 1 | Oral | 0 | |||||||||||
| 126190131 | 12619013 | 13 | C | CALCIUM | CALCIUM | 1 | 630.0MG UNKNOWN | 0 | 630 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126190131 | 12619013 | 1 | Chronic obstructive pulmonary disease |
| 126190131 | 12619013 | 2 | Lung disorder |
| 126190131 | 12619013 | 3 | Lung disorder |
| 126190131 | 12619013 | 4 | Heart rate increased |
| 126190131 | 12619013 | 5 | Cardiovascular event prophylaxis |
| 126190131 | 12619013 | 6 | Prophylaxis |
| 126190131 | 12619013 | 7 | Respiratory disorder |
| 126190131 | 12619013 | 8 | Bone density abnormal |
| 126190131 | 12619013 | 10 | Bone density abnormal |
| 126190131 | 12619013 | 11 | Bone density decreased |
| 126190131 | 12619013 | 12 | Prophylaxis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126190131 | 12619013 | Bone disorder | |
| 126190131 | 12619013 | Device malfunction | |
| 126190131 | 12619013 | Drug dose omission | |
| 126190131 | 12619013 | Intentional product misuse | |
| 126190131 | 12619013 | Lung disorder | |
| 126190131 | 12619013 | Underdose |
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 |
|---|---|---|---|---|---|---|
| 126190131 | 12619013 | 4 | 201510 | 0 | ||
| 126190131 | 12619013 | 6 | 2014 | 0 | ||
| 126190131 | 12619013 | 7 | 2014 | 0 | ||
| 126190131 | 12619013 | 8 | 201601 | 0 | ||
| 126190131 | 12619013 | 11 | 201603 | 0 | ||
| 126190131 | 12619013 | 12 | 2011 | 0 | ||
| 126190131 | 12619013 | 13 | 2014 | 0 |