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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127364721 | 12736472 | 1 | I | 20160602 | 20160907 | 20160912 | 20160912 | PER | US-GLAXOSMITHKLINE-US2016130848 | GLAXOSMITHKLINE | 9.22 | YR | M | Y | 0.00000 | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127364721 | 12736472 | 1 | PS | BREO ELLIPTA | FLUTICASONE FUROATEVILANTEROL TRIFENATATE | 1 | Respiratory (inhalation) | 100/25 MCG, 1 PUFF(S), QD | N | R765952 | 204275 | 1 | DF | INHALATION POWDER | QD | ||||
| 127364721 | 12736472 | 2 | SS | FLOVENT | FLUTICASONE PROPIONATE | 1 | Respiratory (inhalation) | 2 PUFF(S), BID | N | UNKNOWN | 0 | 2 | DF | BID | |||||
| 127364721 | 12736472 | 3 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 127364721 | 12736472 | 4 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | 0 | ||||||||||||
| 127364721 | 12736472 | 5 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127364721 | 12736472 | 1 | Asthma |
| 127364721 | 12736472 | 2 | Asthma |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127364721 | 12736472 | Asthma exercise induced | |
| 127364721 | 12736472 | Cough | |
| 127364721 | 12736472 | Drug dose omission | |
| 127364721 | 12736472 | Lacrimation increased | |
| 127364721 | 12736472 | Ocular hyperaemia | |
| 127364721 | 12736472 | Off label use | |
| 127364721 | 12736472 | Product use issue | |
| 127364721 | 12736472 | 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 |
|---|---|---|---|---|---|---|
| 127364721 | 12736472 | 1 | 20160602 | 0 | ||
| 127364721 | 12736472 | 2 | 201503 | 20160601 | 0 |