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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1056674510 | 10566745 | 10 | F | 2012 | 20160701 | 20141105 | 20160706 | EXP | PHHY2013BR006425 | NOVARTIS | 57.89 | YR | F | Y | 42.00000 | KG | 20160706 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1056674510 | 10566745 | 1 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 150 MG, 1 AMPOULE, QMO | 0 | 150 | MG | /month | |||||||
| 1056674510 | 10566745 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 150 MG, EACH 15 DAYS | 0 | 150 | MG | ||||||||
| 1056674510 | 10566745 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 150 MG, QMO (TWICE) | 0 | 150 | MG | /month | |||||||
| 1056674510 | 10566745 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 150 MG, QMO | 0 | 150 | MG | /month | |||||||
| 1056674510 | 10566745 | 5 | PS | ONBREZ BREEZHALER | INDACATEROL | 1 | Unknown | U | 22383 | DRY POWDER INHALER | |||||||||
| 1056674510 | 10566745 | 6 | SS | HIGROTON | CHLORTHALIDONE | 1 | Unknown | U | 0 | ||||||||||
| 1056674510 | 10566745 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | |||||||||||
| 1056674510 | 10566745 | 8 | SS | FORASEQ | BUDESONIDEFORMOTEROL FUMARATE | 1 | Unknown | U | 0 | ||||||||||
| 1056674510 | 10566745 | 9 | SS | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 1056674510 | 10566745 | 10 | SS | LANTUS | INSULIN GLARGINE | 1 | Unknown | U | 0 | ||||||||||
| 1056674510 | 10566745 | 11 | SS | OXYGEN. | OXYGEN | 1 | Unknown | 0 | |||||||||||
| 1056674510 | 10566745 | 12 | C | GABAPENTIN. | GABAPENTIN | 1 | Oral | 1 DF (400 MG), QD | 0 | 1 | DF | TABLET | QD | ||||||
| 1056674510 | 10566745 | 13 | C | DAXAS | ROFLUMILAST | 1 | Unknown | UNK, QOD | 0 | TABLET | |||||||||
| 1056674510 | 10566745 | 14 | C | DAXAS | ROFLUMILAST | 1 | Oral | 500 MG, QD (STARTED 2 YEARS AGO) | 0 | 500 | MG | TABLET | QD | ||||||
| 1056674510 | 10566745 | 15 | C | BAMIFIX | BAMIFYLLINE HYDROCHLORIDE | 1 | Unknown | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 1056674510 | 10566745 | 16 | C | BAMIFIX | BAMIFYLLINE HYDROCHLORIDE | 1 | Oral | 2 DF, 2 TAB/DAY (300 MG), QD (2 YEARS AGO) | 0 | 2 | DF | TABLET | QD | ||||||
| 1056674510 | 10566745 | 17 | C | ALENIA /01538101/ | BUDESONIDEFORMOTEROL FUMARATE | 1 | Unknown | 2 DF, QD | 0 | 2 | DF | TABLET | QD | ||||||
| 1056674510 | 10566745 | 18 | C | ALENIA /01538101/ | BUDESONIDEFORMOTEROL FUMARATE | 1 | Respiratory (inhalation) | 12 + 400 (UNITS UNSPECIFIED), BID (STARTED 2 YEARS AGO) | 0 | TABLET | BID | ||||||||
| 1056674510 | 10566745 | 19 | C | PREDSIM | PREDNISOLONE | 1 | Unknown | 0 | |||||||||||
| 1056674510 | 10566745 | 20 | C | CLAVULIN | AMOXICILLINCLAVULANIC ACID | 1 | Unknown | 0 | |||||||||||
| 1056674510 | 10566745 | 21 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 1056674510 | 10566745 | 22 | C | D-3 | CHOLECALCIFEROL | 1 | Unknown | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 1056674510 | 10566745 | 23 | C | PURAN | LEVOTHYROXINE SODIUM | 1 | Unknown | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 1056674510 | 10566745 | 24 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 1056674510 | 10566745 | 25 | C | DUOVENT | FENOTEROL HYDROBROMIDE | 1 | Unknown | UNK (2 YEARS AGO) | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1056674510 | 10566745 | 1 | Asthma |
| 1056674510 | 10566745 | 2 | Bronchiectasis |
| 1056674510 | 10566745 | 5 | Product used for unknown indication |
| 1056674510 | 10566745 | 6 | Product used for unknown indication |
| 1056674510 | 10566745 | 7 | Product used for unknown indication |
| 1056674510 | 10566745 | 8 | Product used for unknown indication |
| 1056674510 | 10566745 | 9 | Product used for unknown indication |
| 1056674510 | 10566745 | 10 | Product used for unknown indication |
| 1056674510 | 10566745 | 11 | Product used for unknown indication |
| 1056674510 | 10566745 | 12 | Product used for unknown indication |
| 1056674510 | 10566745 | 13 | Cough |
| 1056674510 | 10566745 | 14 | Dyspnoea |
| 1056674510 | 10566745 | 15 | Lung disorder |
| 1056674510 | 10566745 | 16 | Bronchial disorder |
| 1056674510 | 10566745 | 17 | Lung disorder |
| 1056674510 | 10566745 | 18 | Asthma |
| 1056674510 | 10566745 | 19 | Product used for unknown indication |
| 1056674510 | 10566745 | 20 | Product used for unknown indication |
| 1056674510 | 10566745 | 21 | Depression |
| 1056674510 | 10566745 | 22 | Thyroid disorder |
| 1056674510 | 10566745 | 23 | Thyroid disorder |
| 1056674510 | 10566745 | 24 | Sleep disorder |
| 1056674510 | 10566745 | 25 | Dyspnoea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1056674510 | 10566745 | LT |
| 1056674510 | 10566745 | HO |
| 1056674510 | 10566745 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1056674510 | 10566745 | Asthenia | |
| 1056674510 | 10566745 | Asthmatic crisis | |
| 1056674510 | 10566745 | Bladder disorder | |
| 1056674510 | 10566745 | Blood disorder | |
| 1056674510 | 10566745 | Coma | |
| 1056674510 | 10566745 | Cough | |
| 1056674510 | 10566745 | Dyspnoea | |
| 1056674510 | 10566745 | Lung disorder | |
| 1056674510 | 10566745 | Oxygen consumption decreased | |
| 1056674510 | 10566745 | Pneumonia | |
| 1056674510 | 10566745 | Product use issue | |
| 1056674510 | 10566745 | Speech disorder | |
| 1056674510 | 10566745 | Thrombosis | |
| 1056674510 | 10566745 | Weight decreased | |
| 1056674510 | 10566745 | Weight increased | |
| 1056674510 | 10566745 | Wound |
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 |
|---|---|---|---|---|---|---|
| 1056674510 | 10566745 | 1 | 2012 | 2012 | 0 | |
| 1056674510 | 10566745 | 2 | 20121207 | 0 | ||
| 1056674510 | 10566745 | 3 | 2013 | 0 |