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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126553583 | 12655358 | 3 | F | 201607 | 20160920 | 20160816 | 20160924 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-49413BP | BOEHRINGER INGELHEIM | 72.14 | YR | F | Y | 0.00000 | 20160924 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126553583 | 12655358 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 5 MCG | 502179D,502179,15L0226 | 21936 | 5 | UG | PRESSURISED INHALATION | QD | |||||
| 126553583 | 12655358 | 2 | SS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 2.5 MCG | 502179D,502179,15L0226 | 21936 | 2.5 | UG | PRESSURISED INHALATION | QD | |||||
| 126553583 | 12655358 | 3 | C | ALBUTEROL. | ALBUTEROL | 1 | Respiratory (inhalation) | 2 ANZ | 0 | NEBULISER LIQUID | BID | ||||||||
| 126553583 | 12655358 | 4 | C | ALBUTEROL. | ALBUTEROL | 1 | Unknown | 6 PUF | 0 | Q4H | |||||||||
| 126553583 | 12655358 | 5 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | 2 PUF | 0 | NEBULISER LIQUID | |||||||||
| 126553583 | 12655358 | 6 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 4 PUF | 0 | NEBULISER LIQUID | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126553583 | 12655358 | 1 | Emphysema |
| 126553583 | 12655358 | 3 | Emphysema |
| 126553583 | 12655358 | 4 | Dyspnoea |
| 126553583 | 12655358 | 5 | Emphysema |
| 126553583 | 12655358 | 6 | Emphysema |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126553583 | 12655358 | Cough | |
| 126553583 | 12655358 | Drug ineffective | |
| 126553583 | 12655358 | Dyspnoea | |
| 126553583 | 12655358 | Incorrect dose administered | |
| 126553583 | 12655358 | Product quality issue | |
| 126553583 | 12655358 | Productive cough | |
| 126553583 | 12655358 | Rhinorrhoea |
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 |
|---|---|---|---|---|---|---|
| 126553583 | 12655358 | 1 | 201605 | 0 | ||
| 126553583 | 12655358 | 3 | 201605 | 0 | ||
| 126553583 | 12655358 | 5 | 2011 | 0 |