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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 91269293 | 9126929 | 3 | F | 201211 | 20160810 | 20130228 | 20160817 | EXP | PHHY2013BR017895 | NOVARTIS | 73.93 | YR | F | Y | 60.00000 | KG | 20160817 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 91269293 | 9126929 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Unknown | 1.5 MG, (02 VIALS) | 0 | 1.5 | MG | ||||||||
| 91269293 | 9126929 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Unknown | 300 MG, (02 VIALS) EVERY 15 DAYS | 0 | 300 | MG | ||||||||
| 91269293 | 9126929 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, BIW | 0 | 300 | MG | QOW | |||||||
| 91269293 | 9126929 | 4 | SS | FORASEQ | BUDESONIDEFORMOTEROL FUMARATE | 1 | Respiratory (inhalation) | 2 DF, QD EACH TREATMENT | 0 | 2 | DF | CAPSULE | QD | ||||||
| 91269293 | 9126929 | 5 | C | DIOVAN HCT | HYDROCHLOROTHIAZIDEVALSARTAN | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | QD | |||||
| 91269293 | 9126929 | 6 | C | PRELONE | PREDNISOLONE | 1 | Unknown | UNK | 0 | ||||||||||
| 91269293 | 9126929 | 7 | C | OSTEONUTRI | 2 | Unknown | UNK | 0 | |||||||||||
| 91269293 | 9126929 | 8 | C | DEPURA | CHOLECALCIFEROL | 1 | Unknown | UNK UKN, UNK | 0 | ||||||||||
| 91269293 | 9126929 | 9 | C | SODIUM HYDROXIDE. | SODIUM HYDROXIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 91269293 | 9126929 | 10 | C | BEROTEC | FENOTEROL HYDROBROMIDE | 1 | Respiratory (inhalation) | UNK | U | 0 | |||||||||
| 91269293 | 9126929 | 11 | C | PROLIEF | 2 | Unknown | UNK | 0 | |||||||||||
| 91269293 | 9126929 | 12 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | Oral | 20 MG, QD | U | 0 | 20 | MG | TABLET | QD | |||||
| 91269293 | 9126929 | 13 | C | TAPAZOL | 2 | Oral | 5 MG, QD | U | 0 | 5 | MG | TABLET | QD | ||||||
| 91269293 | 9126929 | 14 | C | DEPURAN | 2 | Oral | 5 DRP, QD | U | 0 | 5 | GTT | DROP | QD | ||||||
| 91269293 | 9126929 | 15 | C | ALENDRONATE | ALENDRONATE SODIUM | 1 | Oral | 70 MG, QW | U | 0 | 70 | MG | /wk | ||||||
| 91269293 | 9126929 | 16 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | Oral | UNK UNK, PRN | U | 0 | |||||||||
| 91269293 | 9126929 | 17 | C | BENADRYL /00647601/ | CAMPHORDIPHENHYDRAMINEINC OXIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 91269293 | 9126929 | 1 | Asthma |
| 91269293 | 9126929 | 4 | Asthma |
| 91269293 | 9126929 | 5 | Hypertension |
| 91269293 | 9126929 | 6 | Product used for unknown indication |
| 91269293 | 9126929 | 7 | Product used for unknown indication |
| 91269293 | 9126929 | 8 | Product used for unknown indication |
| 91269293 | 9126929 | 9 | Product used for unknown indication |
| 91269293 | 9126929 | 10 | Product used for unknown indication |
| 91269293 | 9126929 | 11 | Product used for unknown indication |
| 91269293 | 9126929 | 12 | Blood cholesterol increased |
| 91269293 | 9126929 | 13 | Thyroid disorder |
| 91269293 | 9126929 | 14 | Vitamin supplementation |
| 91269293 | 9126929 | 15 | Osteoporosis |
| 91269293 | 9126929 | 16 | Hypersensitivity |
| 91269293 | 9126929 | 17 | Hypersensitivity |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 91269293 | 9126929 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 91269293 | 9126929 | Asthma | |
| 91269293 | 9126929 | Blood cholesterol increased | |
| 91269293 | 9126929 | Deafness | |
| 91269293 | 9126929 | Dust allergy | |
| 91269293 | 9126929 | Dyspnoea | |
| 91269293 | 9126929 | Head discomfort | |
| 91269293 | 9126929 | Hypotension | |
| 91269293 | 9126929 | Mycotic allergy | |
| 91269293 | 9126929 | Oropharyngeal pain | |
| 91269293 | 9126929 | Productive cough | |
| 91269293 | 9126929 | Pruritus generalised | |
| 91269293 | 9126929 | Renal disorder | |
| 91269293 | 9126929 | Renal vein occlusion | |
| 91269293 | 9126929 | Tinnitus | |
| 91269293 | 9126929 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 91269293 | 9126929 | 2 | 20110201 | 0 | ||
| 91269293 | 9126929 | 3 | 20130515 | 0 |