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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114139496 | 11413949 | 6 | F | 20160826 | 20150824 | 20160831 | PER | US-GLAXOSMITHKLINE-US2015120041 | GLAXOSMITHKLINE | 0.00 | F | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114139496 | 11413949 | 1 | PS | ADVAIR DISKUS | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Respiratory (inhalation) | 1 PUFF(S), BID | U | 4ZP5855 | 21077 | 1 | DF | INHALATION POWDER | BID | ||||
| 114139496 | 11413949 | 2 | SS | ADVAIR DISKUS | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | UNK, U | U | 21077 | INHALATION POWDER | |||||||||
| 114139496 | 11413949 | 3 | SS | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | Unknown | UNK, U | U | 5ZP0333 | 0 | ||||||||
| 114139496 | 11413949 | 4 | SS | BREO ELLIPTA | FLUTICASONE FUROATEVILANTEROL TRIFENATATE | 1 | Respiratory (inhalation) | UNK, U | U | 0 | INHALATION POWDER | ||||||||
| 114139496 | 11413949 | 5 | SS | BREO ELLIPTA | FLUTICASONE FUROATEVILANTEROL TRIFENATATE | 1 | Respiratory (inhalation) | 100/25 MCG UNK, U | U | 0 | INHALATION POWDER | ||||||||
| 114139496 | 11413949 | 6 | C | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | 0 | ||||||||||||
| 114139496 | 11413949 | 7 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | 0 | ||||||||||||
| 114139496 | 11413949 | 8 | C | FLUTICASONE PROPIONATE. | FLUTICASONE PROPIONATE | 1 | 0 | ||||||||||||
| 114139496 | 11413949 | 9 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | 0 | ||||||||||||
| 114139496 | 11413949 | 10 | C | CYCLOBENZAPRINE | CYCLOBENZAPRINE | 1 | 0 | ||||||||||||
| 114139496 | 11413949 | 11 | C | GABAPENTIN. | GABAPENTIN | 1 | 0 | ||||||||||||
| 114139496 | 11413949 | 12 | C | LORATIDINE | LORATADINE | 1 | 0 | ||||||||||||
| 114139496 | 11413949 | 13 | C | METOPROLOL. | METOPROLOL | 1 | 0 | ||||||||||||
| 114139496 | 11413949 | 14 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 114139496 | 11413949 | 15 | C | PRAVASTATIN. | PRAVASTATIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114139496 | 11413949 | 1 | Chronic obstructive pulmonary disease |
| 114139496 | 11413949 | 2 | Emphysema |
| 114139496 | 11413949 | 3 | Chronic obstructive pulmonary disease |
| 114139496 | 11413949 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114139496 | 11413949 | HO |
| 114139496 | 11413949 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114139496 | 11413949 | Bronchitis | |
| 114139496 | 11413949 | Drug ineffective | |
| 114139496 | 11413949 | Dysphonia | |
| 114139496 | 11413949 | Dyspnoea | |
| 114139496 | 11413949 | Emergency care examination | |
| 114139496 | 11413949 | Hyperhidrosis | |
| 114139496 | 11413949 | Pneumonia | |
| 114139496 | 11413949 | Respiratory tract congestion | |
| 114139496 | 11413949 | Tooth discolouration | |
| 114139496 | 11413949 | Upper respiratory tract infection | |
| 114139496 | 11413949 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 114139496 | 11413949 | 1 | 2013 | 0 | ||
| 114139496 | 11413949 | 2 | 201608 | 0 | ||
| 114139496 | 11413949 | 5 | 201608 | 0 |