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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122377273 | 12237727 | 3 | F | 2015 | 20160729 | 20160405 | 20160808 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-19698BP | BOEHRINGER INGELHEIM | 65.23 | YR | M | Y | 86.18000 | KG | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122377273 | 12237727 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | N | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | |||||
| 122377273 | 12237727 | 2 | SS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 2 ANZ | 21936 | PRESSURISED INHALATION | QD | ||||||||
| 122377273 | 12237727 | 3 | SS | COMBIVENT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | Respiratory (inhalation) | 4 ANZ | 21747 | PRESSURISED INHALATION | |||||||||
| 122377273 | 12237727 | 4 | SS | COMBIVENT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | Respiratory (inhalation) | 3 ANZ | N | 21747 | INHALATION SOLUTION | TID | |||||||
| 122377273 | 12237727 | 5 | C | DULERA | FORMOTEROL FUMARATE DIHYDRATEMOMETASONE FUROATE | 1 | Respiratory (inhalation) | 4 ANZ | 0 | NEBULISER LIQUID | BID | ||||||||
| 122377273 | 12237727 | 6 | C | ALBUTEROL. | ALBUTEROL | 1 | Unknown | NEBULIZER | 0 | ||||||||||
| 122377273 | 12237727 | 7 | C | JALYN | DUTASTERIDETAMSULOSIN HYDROCHLORIDE | 1 | Oral | 1 ANZ | 0 | CAPSULE | QD | ||||||||
| 122377273 | 12237727 | 8 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Oral | 0.25 MG | 0 | .25 | MG | TABLET | QD | ||||||
| 122377273 | 12237727 | 9 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 8 MG | 0 | 4 | MG | TABLET | BID | ||||||
| 122377273 | 12237727 | 10 | C | LOVASTATIN. | LOVASTATIN | 1 | Oral | 20 MG | 0 | 20 | MG | TABLET | QD | ||||||
| 122377273 | 12237727 | 11 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | Oral | 400 MG | 0 | 400 | MG | TABLET | QD | ||||||
| 122377273 | 12237727 | 12 | C | ONDANSETRON HCL | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 0 | 4 | MG | TABLET | ||||||||
| 122377273 | 12237727 | 13 | C | PERCOCET | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Oral | DOSE PER APPLICATION: 5MG-325MG | 0 | TABLET | |||||||||
| 122377273 | 12237727 | 14 | C | POLYETHYLENE GLYCOL | POLYETHYLENE GLYCOLS | 1 | Unknown | 17 G | 0 | 17 | G | QD | |||||||
| 122377273 | 12237727 | 15 | C | SENOKOT-S | DOCUSATE SODIUMSENNOSIDES | 1 | Oral | 2 ANZ | 0 | TABLET | QD | ||||||||
| 122377273 | 12237727 | 16 | C | TUSSIONEX PENNKINETIC | CHLORPHENIRAMINEHYDROCODONE | 1 | Oral | FORMULATION ER; STRENGTH:: 10MG-8MG/ML | 0 | ORAL SUSPENSION | |||||||||
| 122377273 | 12237727 | 17 | C | VENTOLIN HFA | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | FORMULATION: AEROSOL INHALER | 0 | PRESSURISED INHALATION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122377273 | 12237727 | 1 | Chronic obstructive pulmonary disease |
| 122377273 | 12237727 | 2 | Chronic obstructive pulmonary disease |
| 122377273 | 12237727 | 3 | Chronic obstructive pulmonary disease |
| 122377273 | 12237727 | 4 | Chronic obstructive pulmonary disease |
| 122377273 | 12237727 | 5 | Chronic obstructive pulmonary disease |
| 122377273 | 12237727 | 6 | Product used for unknown indication |
| 122377273 | 12237727 | 7 | Prostatomegaly |
| 122377273 | 12237727 | 8 | Product used for unknown indication |
| 122377273 | 12237727 | 9 | Product used for unknown indication |
| 122377273 | 12237727 | 10 | Product used for unknown indication |
| 122377273 | 12237727 | 11 | Product used for unknown indication |
| 122377273 | 12237727 | 12 | Product used for unknown indication |
| 122377273 | 12237727 | 13 | Product used for unknown indication |
| 122377273 | 12237727 | 14 | Product used for unknown indication |
| 122377273 | 12237727 | 15 | Product used for unknown indication |
| 122377273 | 12237727 | 16 | Product used for unknown indication |
| 122377273 | 12237727 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122377273 | 12237727 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122377273 | 12237727 | General physical health deterioration | |
| 122377273 | 12237727 | Haemoptysis | |
| 122377273 | 12237727 | Lung carcinoma cell type unspecified stage IV | |
| 122377273 | 12237727 | Lung neoplasm malignant |
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 |
|---|---|---|---|---|---|---|
| 122377273 | 12237727 | 1 | 2008 | 2014 | 0 | |
| 122377273 | 12237727 | 2 | 2014 | 0 | ||
| 122377273 | 12237727 | 3 | 2011 | 0 | ||
| 122377273 | 12237727 | 4 | 2001 | 2011 | 0 | |
| 122377273 | 12237727 | 5 | 2001 | 0 | ||
| 122377273 | 12237727 | 7 | 2009 | 0 |