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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 128006561 | 12800656 | 1 | I | 20160704 | 20160915 | 20160930 | 20160930 | EXP | US-BAUSCH-BL-2016-023843 | BAUSCH AND LOMB | 0.00 | E | F | Y | 0.00000 | 20160930 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 128006561 | 12800656 | 1 | PS | ALBUTEROL. | ALBUTEROL | 1 | 1 AS NECESSARY | 75050 | 180 | UG | |||||||||
| 128006561 | 12800656 | 2 | SS | AZELASTINE HYDROCHLORIDE. | AZELASTINE HYDROCHLORIDE | 1 | Nasal | 0 | NASAL SPRAY, SOLUTION | ||||||||||
| 128006561 | 12800656 | 3 | SS | EYLEA | AFLIBERCEPT | 1 | Intraocular | RIGHT EYE, ONCE MONTHLY FOR 3 INJECTIONS THEN EVERY 2 MONTHS | Y | 0 | 2 | MG | INJECTION | ||||||
| 128006561 | 12800656 | 4 | SS | EYLEA | AFLIBERCEPT | 1 | Intraocular | RIGHT EYE, ONCE MONTHLY FOR 3 INJECTIONS THEN EVERY 2 MONTHS | Y | 0 | 2 | MG | INJECTION | ||||||
| 128006561 | 12800656 | 5 | SS | EYLEA | AFLIBERCEPT | 1 | Intraocular | RIGHT EYE, ONCE MONTHLY FOR 3 INJECTIONS THEN EVERY 2 MONTHS | Y | 0 | 2 | MG | INJECTION | ||||||
| 128006561 | 12800656 | 6 | SS | GABAPENTIN. | GABAPENTIN | 1 | Unknown | Y | 0 | QD | |||||||||
| 128006561 | 12800656 | 7 | SS | GABAPENTIN. | GABAPENTIN | 1 | Y | 0 | |||||||||||
| 128006561 | 12800656 | 8 | SS | FLONASE | FLUTICASONE PROPIONATE | 1 | Nasal | 0 | NASAL SPRAY | ||||||||||
| 128006561 | 12800656 | 9 | SS | MONTELUKAST SODIUM. | MONTELUKAST SODIUM | 1 | Unknown | 0 | 10 | MG | QD | ||||||||
| 128006561 | 12800656 | 10 | SS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | 0 | 2 | DF | BID | ||||||||
| 128006561 | 12800656 | 11 | SS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | 0 | QD | ||||||||||
| 128006561 | 12800656 | 12 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | 0 | 10 | MG | QD | ||||||||
| 128006561 | 12800656 | 13 | C | LOSARTAN POTASSIUM W/HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM | 1 | Unknown | 0 | |||||||||||
| 128006561 | 12800656 | 14 | C | ZETIA | EZETIMIBE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 128006561 | 12800656 | 1 | Asthma |
| 128006561 | 12800656 | 2 | Asthma |
| 128006561 | 12800656 | 3 | Neovascular age-related macular degeneration |
| 128006561 | 12800656 | 6 | Spinal column stenosis |
| 128006561 | 12800656 | 8 | Asthma |
| 128006561 | 12800656 | 9 | Asthma |
| 128006561 | 12800656 | 10 | Asthma |
| 128006561 | 12800656 | 11 | Asthma |
| 128006561 | 12800656 | 12 | Asthma |
| 128006561 | 12800656 | 13 | Product used for unknown indication |
| 128006561 | 12800656 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 128006561 | 12800656 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 128006561 | 12800656 | Asthma | |
| 128006561 | 12800656 | Drug ineffective for unapproved indication | |
| 128006561 | 12800656 | Eosinophil count increased | |
| 128006561 | 12800656 | Off label use | |
| 128006561 | 12800656 | Pulmonary function test decreased | |
| 128006561 | 12800656 | Transient ischaemic attack |
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 |
|---|---|---|---|---|---|---|
| 128006561 | 12800656 | 3 | 20160524 | 20160524 | 0 | |
| 128006561 | 12800656 | 4 | 20160621 | 20160621 | 0 | |
| 128006561 | 12800656 | 5 | 20160719 | 20160719 | 0 | |
| 128006561 | 12800656 | 6 | 201601 | 201602 | 0 | |
| 128006561 | 12800656 | 7 | 20160703 | 201607 | 0 |