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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122407012 | 12240701 | 2 | F | 2015 | 20160804 | 20160406 | 20160811 | PER | US-ASTRAZENECA-2016SE35406 | ASTRAZENECA | 59.00 | YR | F | Y | 62.10000 | KG | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122407012 | 12240701 | 1 | PS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160/4.5 MCG, TWO PUFFS, TWICE A DAY | 3001015C00 | 21929 | |||||||||
| 122407012 | 12240701 | 2 | SS | DALIRESP | ROFLUMILAST | 1 | Oral | Y | U | 0 | 500 | UG | TABLET | QD | |||||
| 122407012 | 12240701 | 3 | SS | DALIRESP | ROFLUMILAST | 1 | Oral | Y | U | 0 | 500 | UG | TABLET | QD | |||||
| 122407012 | 12240701 | 4 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 0 | 2.5 | MG | QD | ||||||||
| 122407012 | 12240701 | 5 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | TWO PUFFS AS NEEDED UP TO FOUR PER DAY | 0 | ||||||||||
| 122407012 | 12240701 | 6 | C | MUCINEX | GUAIFENESIN | 1 | Oral | 0 | 400 | MG | TABLET | BID | |||||||
| 122407012 | 12240701 | 7 | C | MUCINEX | GUAIFENESIN | 1 | Oral | ONE OR TWO TABLETS, TWICE A DAY | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122407012 | 12240701 | 1 | Chronic obstructive pulmonary disease |
| 122407012 | 12240701 | 2 | Chronic obstructive pulmonary disease |
| 122407012 | 12240701 | 3 | Secretion discharge |
| 122407012 | 12240701 | 4 | Chronic obstructive pulmonary disease |
| 122407012 | 12240701 | 5 | Dyspnoea |
| 122407012 | 12240701 | 6 | Mucous membrane disorder |
| 122407012 | 12240701 | 7 | Mucous membrane disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122407012 | 12240701 | Back pain | |
| 122407012 | 12240701 | Chronic obstructive pulmonary disease | |
| 122407012 | 12240701 | Cough | |
| 122407012 | 12240701 | Diarrhoea | |
| 122407012 | 12240701 | Dizziness | |
| 122407012 | 12240701 | Drug dose omission | |
| 122407012 | 12240701 | Dysgeusia | |
| 122407012 | 12240701 | Dyspnoea | |
| 122407012 | 12240701 | Hypotension | |
| 122407012 | 12240701 | Intentional product misuse | |
| 122407012 | 12240701 | Malaise | |
| 122407012 | 12240701 | Product quality issue |
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 |
|---|---|---|---|---|---|---|
| 122407012 | 12240701 | 1 | 201410 | 0 | ||
| 122407012 | 12240701 | 2 | 2015 | 2015 | 0 | |
| 122407012 | 12240701 | 3 | 2015 | 2015 | 0 | |
| 122407012 | 12240701 | 4 | 2014 | 0 |