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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123834642 | 12383464 | 2 | F | 2014 | 20160520 | 20160518 | 20160712 | PER | US-ASTRAZENECA-2016SE41519 | ASTRAZENECA | 57.00 | YR | F | Y | 73.90000 | KG | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123834642 | 12383464 | 1 | PS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 320 UG; TWO TIMES A DAY; 160/4.5 MCG 120 INHALATIONS | U | U | 3001125C00 | 21929 | |||||||
| 123834642 | 12383464 | 2 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 2 PUFFS 2 TIMES DAILY | U | U | 3001125C00 | 21929 | |||||||
| 123834642 | 12383464 | 3 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 0 | QD | ||||||||||
| 123834642 | 12383464 | 4 | C | VENTOLIN RESCUE INHALER | 2 | Respiratory (inhalation) | AS REQUIRED | 0 | |||||||||||
| 123834642 | 12383464 | 5 | C | ALBUTEROL. | ALBUTEROL | 1 | Respiratory (inhalation) | AS REQUIRED | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123834642 | 12383464 | 1 | Chronic obstructive pulmonary disease |
| 123834642 | 12383464 | 2 | Chronic obstructive pulmonary disease |
| 123834642 | 12383464 | 3 | Chronic obstructive pulmonary disease |
| 123834642 | 12383464 | 4 | Chronic obstructive pulmonary disease |
| 123834642 | 12383464 | 5 | Chronic obstructive pulmonary disease |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123834642 | 12383464 | Product quality issue | |
| 123834642 | 12383464 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 123834642 | 12383464 | 1 | 2013 | 0 | ||
| 123834642 | 12383464 | 2 | 20160412 | 0 |