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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117046685 | 11704668 | 5 | F | 20140731 | 20160728 | 20151106 | 20160802 | EXP | PHHY2014CA103299 | NOVARTIS | 79.11 | YR | M | Y | 0.00000 | 20160802 | CN | COUNTRY NOT SPECIFIED | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117046685 | 11704668 | 1 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, EVERY 2 WEEKS | U | 0 | 375 | MG | QOW | ||||||
| 117046685 | 11704668 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 117046685 | 11704668 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 117046685 | 11704668 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 117046685 | 11704668 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 117046685 | 11704668 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 117046685 | 11704668 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 117046685 | 11704668 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 117046685 | 11704668 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 117046685 | 11704668 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 117046685 | 11704668 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 117046685 | 11704668 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 117046685 | 11704668 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 117046685 | 11704668 | 14 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A/S0062 | 0 | ||||||||
| 117046685 | 11704668 | 15 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0002F | 0 | ||||||||
| 117046685 | 11704668 | 16 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 117046685 | 11704668 | 17 | PS | SEEBRI BREEZHALER | GLYCOPYRROLATE | 1 | Respiratory (inhalation) | U | 207923 | ||||||||||
| 117046685 | 11704668 | 18 | SS | IODINE. | IODINE | 1 | Unknown | U | 0 | ||||||||||
| 117046685 | 11704668 | 19 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 117046685 | 11704668 | 20 | C | ALVESCO | CICLESONIDE | 1 | Unknown | U | 0 | ||||||||||
| 117046685 | 11704668 | 21 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 117046685 | 11704668 | 22 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 117046685 | 11704668 | 23 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 117046685 | 11704668 | 24 | C | AVASTIN | BEVACIZUMAB | 1 | Unknown | U | 0 | ||||||||||
| 117046685 | 11704668 | 25 | C | DILTIAZEM. | DILTIAZEM | 1 | Unknown | U | 0 | ||||||||||
| 117046685 | 11704668 | 26 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 117046685 | 11704668 | 27 | C | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | U | 0 | ||||||||||
| 117046685 | 11704668 | 28 | C | CALCITE | CALCIUM CARBONATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117046685 | 11704668 | 1 | Asthma |
| 117046685 | 11704668 | 17 | Product used for unknown indication |
| 117046685 | 11704668 | 18 | Product used for unknown indication |
| 117046685 | 11704668 | 19 | Product used for unknown indication |
| 117046685 | 11704668 | 20 | Product used for unknown indication |
| 117046685 | 11704668 | 21 | Product used for unknown indication |
| 117046685 | 11704668 | 22 | Product used for unknown indication |
| 117046685 | 11704668 | 23 | Product used for unknown indication |
| 117046685 | 11704668 | 24 | Product used for unknown indication |
| 117046685 | 11704668 | 25 | Product used for unknown indication |
| 117046685 | 11704668 | 26 | Product used for unknown indication |
| 117046685 | 11704668 | 27 | Product used for unknown indication |
| 117046685 | 11704668 | 28 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117046685 | 11704668 | HO |
| 117046685 | 11704668 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117046685 | 11704668 | Acne | |
| 117046685 | 11704668 | Arthralgia | |
| 117046685 | 11704668 | Asthenia | |
| 117046685 | 11704668 | Blood pressure systolic increased | |
| 117046685 | 11704668 | Body temperature decreased | |
| 117046685 | 11704668 | Contusion | |
| 117046685 | 11704668 | Cough | |
| 117046685 | 11704668 | Drug intolerance | |
| 117046685 | 11704668 | Dyspnoea | |
| 117046685 | 11704668 | Dysuria | |
| 117046685 | 11704668 | Fatigue | |
| 117046685 | 11704668 | Flank pain | |
| 117046685 | 11704668 | Headache | |
| 117046685 | 11704668 | Malaise | |
| 117046685 | 11704668 | Nasopharyngitis | |
| 117046685 | 11704668 | Nausea | |
| 117046685 | 11704668 | Productive cough | |
| 117046685 | 11704668 | Rash erythematous | |
| 117046685 | 11704668 | Secretion discharge | |
| 117046685 | 11704668 | Sputum discoloured | |
| 117046685 | 11704668 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 117046685 | 11704668 | 1 | 20140731 | 0 | ||
| 117046685 | 11704668 | 2 | 20140814 | 0 | ||
| 117046685 | 11704668 | 3 | 20141008 | 0 | ||
| 117046685 | 11704668 | 4 | 20141217 | 0 | ||
| 117046685 | 11704668 | 5 | 20141230 | 0 | ||
| 117046685 | 11704668 | 6 | 20150114 | 0 | ||
| 117046685 | 11704668 | 7 | 20150128 | 0 | ||
| 117046685 | 11704668 | 8 | 20150211 | 0 | ||
| 117046685 | 11704668 | 9 | 20150409 | 0 | ||
| 117046685 | 11704668 | 10 | 20150812 | 0 | ||
| 117046685 | 11704668 | 11 | 20150923 | 0 | ||
| 117046685 | 11704668 | 12 | 20151007 | 0 | ||
| 117046685 | 11704668 | 13 | 20151021 | 0 | ||
| 117046685 | 11704668 | 14 | 20160309 | 0 | ||
| 117046685 | 11704668 | 15 | 20160713 | 0 | ||
| 117046685 | 11704668 | 16 | 20160728 | 0 |