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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126194061 | 12619406 | 1 | I | 201602 | 20160727 | 20160803 | 20160803 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-49453BP | BOEHRINGER INGELHEIM | 53.33 | YR | F | Y | 0.00000 | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126194061 | 12619406 | 1 | PS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 18 MCG | 508421A | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | |||||
| 126194061 | 12619406 | 2 | SS | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Oral | 18 MCG | 508421A | 21395 | 18 | UG | INHALATION POWDER, HARD CAPSULE | QD | |||||
| 126194061 | 12619406 | 3 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 1 ANZ | 0 | TABLET | QD | ||||||||
| 126194061 | 12619406 | 4 | C | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDELISINOPRIL | 1 | Oral | DOSE PER APPLICATION AND DAILY DOSE: 10 MG / 12.5 MG; | 0 | TABLET | QD | ||||||||
| 126194061 | 12619406 | 5 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 40 MG | 0 | 40 | MG | TABLET | QD | ||||||
| 126194061 | 12619406 | 6 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Oral | 40 MG | 0 | 40 | MG | QD | |||||||
| 126194061 | 12619406 | 7 | C | ROBAXIN | METHOCARBAMOL | 1 | Oral | 1500 MG | 0 | 500 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126194061 | 12619406 | 1 | Chronic obstructive pulmonary disease |
| 126194061 | 12619406 | 3 | Product used for unknown indication |
| 126194061 | 12619406 | 4 | Hypertension |
| 126194061 | 12619406 | 5 | Blood cholesterol increased |
| 126194061 | 12619406 | 6 | Gastrooesophageal reflux disease |
| 126194061 | 12619406 | 7 | Neck pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126194061 | 12619406 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126194061 | 12619406 | Brain neoplasm malignant | |
| 126194061 | 12619406 | Incorrect route of drug administration | |
| 126194061 | 12619406 | Lung neoplasm malignant | |
| 126194061 | 12619406 | Lymphadenopathy |
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 |
|---|---|---|---|---|---|---|
| 126194061 | 12619406 | 2 | 20160727 | 20160727 | 0 | |
| 126194061 | 12619406 | 3 | 201604 | 0 |