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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122941633 | 12294163 | 3 | F | 20121120 | 20160919 | 20160422 | 20160921 | EXP | CA-ROCHE-1745200 | ROCHE | 41.77 | YR | M | Y | 0.00000 | 20160921 | CN | CA | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122941633 | 12294163 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 225 MG, BIW | U | S0065E,S0060A,S0068D | 103976 | 225 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 122941633 | 12294163 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122941633 | 12294163 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122941633 | 12294163 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122941633 | 12294163 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 225 MG, Q 4 WEEKS | U | S0065E,S0060A,S0068D | 103976 | 225 | MG | SOLUTION FOR INJECTION | |||||
| 122941633 | 12294163 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 200 MG, Q 4 WEEKS | U | S0065E,S0060A,S0068D | 103976 | 225 | MG | SOLUTION FOR INJECTION | |||||
| 122941633 | 12294163 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 200 MG, UNK | U | S0065E,S0060A,S0068D | 103976 | 200 | MG | SOLUTION FOR INJECTION | |||||
| 122941633 | 12294163 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122941633 | 12294163 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 225 MG, BIW | U | S0065E,S0060A,S0068D | 103976 | 225 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 122941633 | 12294163 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122941633 | 12294163 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122941633 | 12294163 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 225 MG, BIW | U | S0065E,S0060A,S0068D | 103976 | 225 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 122941633 | 12294163 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122941633 | 12294163 | 14 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122941633 | 12294163 | 15 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122941633 | 12294163 | 16 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122941633 | 12294163 | 17 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122941633 | 12294163 | 18 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 122941633 | 12294163 | 19 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | 225 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 122941633 | 12294163 | 20 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | 225 | MG | SOLUTION FOR INJECTION | |||||
| 122941633 | 12294163 | 21 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | 225 | MG | SOLUTION FOR INJECTION | |||||
| 122941633 | 12294163 | 22 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0060A,S0068D | 103976 | 225 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 122941633 | 12294163 | 23 | C | PULMICORT TURBUHALER | BUDESONIDE | 1 | Unknown | U | 0 | ||||||||||
| 122941633 | 12294163 | 24 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 122941633 | 12294163 | 25 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | U | S0060A | 0 | |||||||||
| 122941633 | 12294163 | 26 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122941633 | 12294163 | 1 | Asthma |
| 122941633 | 12294163 | 23 | Product used for unknown indication |
| 122941633 | 12294163 | 24 | Product used for unknown indication |
| 122941633 | 12294163 | 25 | Product used for unknown indication |
| 122941633 | 12294163 | 26 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122941633 | 12294163 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122941633 | 12294163 | Blood pressure increased | |
| 122941633 | 12294163 | Body temperature decreased | |
| 122941633 | 12294163 | Diarrhoea | |
| 122941633 | 12294163 | Drug ineffective | |
| 122941633 | 12294163 | Dyspnoea | |
| 122941633 | 12294163 | Headache | |
| 122941633 | 12294163 | Influenza | |
| 122941633 | 12294163 | Malaise | |
| 122941633 | 12294163 | Nasal congestion | |
| 122941633 | 12294163 | Nasal polyps | |
| 122941633 | 12294163 | Nasopharyngitis | |
| 122941633 | 12294163 | Pneumonia | |
| 122941633 | 12294163 | Respiratory disorder | |
| 122941633 | 12294163 | Sinus congestion | |
| 122941633 | 12294163 | Umbilical hernia | |
| 122941633 | 12294163 | Vomiting | |
| 122941633 | 12294163 | Weight decreased | |
| 122941633 | 12294163 | Weight fluctuation | |
| 122941633 | 12294163 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 122941633 | 12294163 | 1 | 20121024 | 0 | ||
| 122941633 | 12294163 | 2 | 20121120 | 0 | ||
| 122941633 | 12294163 | 3 | 20121206 | 0 | ||
| 122941633 | 12294163 | 4 | 20130206 | 0 | ||
| 122941633 | 12294163 | 7 | 20130918 | 0 | ||
| 122941633 | 12294163 | 8 | 20131023 | 0 | ||
| 122941633 | 12294163 | 9 | 20131218 | 0 | ||
| 122941633 | 12294163 | 10 | 20140306 | 0 | ||
| 122941633 | 12294163 | 11 | 20150319 | 0 | ||
| 122941633 | 12294163 | 12 | 20150514 | 0 | ||
| 122941633 | 12294163 | 13 | 20150528 | 0 | ||
| 122941633 | 12294163 | 14 | 20150611 | 0 | ||
| 122941633 | 12294163 | 15 | 20150625 | 0 | ||
| 122941633 | 12294163 | 16 | 20150708 | 0 | ||
| 122941633 | 12294163 | 17 | 20160414 | 0 | ||
| 122941633 | 12294163 | 18 | 20160428 | 0 | ||
| 122941633 | 12294163 | 19 | 20160623 | 0 | ||
| 122941633 | 12294163 | 20 | 20160727 | 0 | ||
| 122941633 | 12294163 | 21 | 20160818 | 0 | ||
| 122941633 | 12294163 | 22 | 20160915 | 0 |