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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124473682 | 12447368 | 2 | F | 2013 | 20160718 | 20160608 | 20160804 | EXP | US-GLAXOSMITHKLINE-US2016073716 | GLAXOSMITHKLINE | 72.89 | YR | M | Y | 0.00000 | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124473682 | 12447368 | 1 | PS | FLOVENT DISKUS | FLUTICASONE PROPIONATE | 1 | Respiratory (inhalation) | 110 MCG 1 PUFF(S), BID | Y | UNKNOWN | 21433 | 1 | DF | BID | |||||
| 124473682 | 12447368 | 2 | SS | FLOVENT DISKUS | FLUTICASONE PROPIONATE | 1 | Respiratory (inhalation) | 220 MCG 1 PUFF(S), BID | Y | 21433 | 1 | DF | BID | ||||||
| 124473682 | 12447368 | 3 | SS | INCRUSE ELLIPTA | UMECLIDINIUM BROMIDE | 1 | Respiratory (inhalation) | 1 PUFF(S), QD | UNKNOWN | 0 | 1 | DF | INHALATION POWDER | QD | |||||
| 124473682 | 12447368 | 4 | SS | INCRUSE ELLIPTA | UMECLIDINIUM BROMIDE | 1 | 0 | INHALATION POWDER | |||||||||||
| 124473682 | 12447368 | 5 | SS | PROVENTIL | ALBUTEROL | 1 | Respiratory (inhalation) | 2 PUFF(S), U | Y | UNKNOWN | 0 | 2 | DF | ||||||
| 124473682 | 12447368 | 6 | SS | ADVAIR DISKUS | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Respiratory (inhalation) | 250/50 MCG 1 PUFF(S), BID | 6ZP4187 | 0 | 1 | DF | INHALATION POWDER | BID | |||||
| 124473682 | 12447368 | 7 | SS | MONTELUKAST | MONTELUKAST SODIUM | 1 | UNK UNK, U | UNKNOWN | 0 | ||||||||||
| 124473682 | 12447368 | 8 | SS | QUINAPRIL. | QUINAPRIL | 1 | Oral | 10 MG, QD | UNKNOWN | 0 | 10 | MG | QD | ||||||
| 124473682 | 12447368 | 9 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | U | 0 | |||||||||||
| 124473682 | 12447368 | 10 | C | BETA SITOSTEROL | 2 | U | 0 | ||||||||||||
| 124473682 | 12447368 | 11 | C | POLICOSANOL | 2 | U | 0 | ||||||||||||
| 124473682 | 12447368 | 12 | C | PREDNISONE. | PREDNISONE | 1 | U | 0 | |||||||||||
| 124473682 | 12447368 | 13 | C | SAW PALMETTO | SAW PALMETTO | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124473682 | 12447368 | 1 | Asthma |
| 124473682 | 12447368 | 3 | Asthma |
| 124473682 | 12447368 | 4 | Hypertension |
| 124473682 | 12447368 | 5 | Asthma |
| 124473682 | 12447368 | 6 | Asthma |
| 124473682 | 12447368 | 8 | Hypertension |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124473682 | 12447368 | Adverse event | |
| 124473682 | 12447368 | Blood creatinine increased | |
| 124473682 | 12447368 | Blood potassium increased | |
| 124473682 | 12447368 | Bronchitis | |
| 124473682 | 12447368 | Chronic obstructive pulmonary disease | |
| 124473682 | 12447368 | Depression | |
| 124473682 | 12447368 | Device use error | |
| 124473682 | 12447368 | Drug dose omission | |
| 124473682 | 12447368 | Drug ineffective | |
| 124473682 | 12447368 | Dyspnoea | |
| 124473682 | 12447368 | Exercise tolerance decreased | |
| 124473682 | 12447368 | Fatigue | |
| 124473682 | 12447368 | Insomnia | |
| 124473682 | 12447368 | Intentional product misuse | |
| 124473682 | 12447368 | Micturition urgency | |
| 124473682 | 12447368 | Oedema peripheral | |
| 124473682 | 12447368 | Peak expiratory flow rate decreased | |
| 124473682 | 12447368 | Spirometry abnormal |
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 |
|---|---|---|---|---|---|---|
| 124473682 | 12447368 | 1 | 2002 | 0 | ||
| 124473682 | 12447368 | 2 | 201605 | 0 | ||
| 124473682 | 12447368 | 3 | 201605 | 0 | ||
| 124473682 | 12447368 | 5 | 1991 | 0 | ||
| 124473682 | 12447368 | 6 | 201605 | 0 | ||
| 124473682 | 12447368 | 8 | 2011 | 0 |