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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97743164 | 9774316 | 4 | F | 20120703 | 20160901 | 20131220 | 20160908 | EXP | CA-ROCHE-1322658 | ROCHE | 36.13 | YR | F | Y | 0.00000 | 20160908 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97743164 | 9774316 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | 225 | MG | SOLUTION FOR INJECTION | QOW | ||||||
| 97743164 | 9774316 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | 225 | MG | SOLUTION FOR INJECTION | QOW | ||||||
| 97743164 | 9774316 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | SOLUTION FOR INJECTION | |||||||||
| 97743164 | 9774316 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | SOLUTION FOR INJECTION | |||||||||
| 97743164 | 9774316 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | 225 | MG | SOLUTION FOR INJECTION | QOW | ||||||
| 97743164 | 9774316 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | SOLUTION FOR INJECTION | |||||||||
| 97743164 | 9774316 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | SOLUTION FOR INJECTION | |||||||||
| 97743164 | 9774316 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | SOLUTION FOR INJECTION | |||||||||
| 97743164 | 9774316 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | SOLUTION FOR INJECTION | |||||||||
| 97743164 | 9774316 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | 225 | MG | SOLUTION FOR INJECTION | BIW | ||||||
| 97743164 | 9774316 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | 300 | MG | SOLUTION FOR INJECTION | BIW | ||||||
| 97743164 | 9774316 | 12 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
| 97743164 | 9774316 | 13 | C | ALVESCO | CICLESONIDE | 1 | 0 | ||||||||||||
| 97743164 | 9774316 | 14 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | 0 | 200 | MG | |||||||||
| 97743164 | 9774316 | 15 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | 0 | 200 | MG | |||||||||
| 97743164 | 9774316 | 16 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | 0 | ||||||||||||
| 97743164 | 9774316 | 17 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | |||||||||||
| 97743164 | 9774316 | 18 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | |||||||||||
| 97743164 | 9774316 | 19 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | |||||||||||
| 97743164 | 9774316 | 20 | C | ZENHALE | FORMOTEROL FUMARATEMOMETASONE FUROATE | 1 | 0 | ||||||||||||
| 97743164 | 9774316 | 21 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
| 97743164 | 9774316 | 22 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0 | ||||||||||||
| 97743164 | 9774316 | 23 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 97743164 | 9774316 | 1 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 97743164 | 9774316 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 97743164 | 9774316 | Body temperature decreased | |
| 97743164 | 9774316 | Concussion | |
| 97743164 | 9774316 | Contusion | |
| 97743164 | 9774316 | Dizziness | |
| 97743164 | 9774316 | Drug ineffective | |
| 97743164 | 9774316 | Fall | |
| 97743164 | 9774316 | Fatigue | |
| 97743164 | 9774316 | Feeling abnormal | |
| 97743164 | 9774316 | Incorrect route of drug administration | |
| 97743164 | 9774316 | Palpitations | |
| 97743164 | 9774316 | Syncope |
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 |
|---|---|---|---|---|---|---|
| 97743164 | 9774316 | 1 | 20081212 | 0 | ||
| 97743164 | 9774316 | 2 | 20090423 | 0 | ||
| 97743164 | 9774316 | 3 | 20120731 | 0 | ||
| 97743164 | 9774316 | 4 | 20120814 | 0 | ||
| 97743164 | 9774316 | 5 | 20130131 | 0 | ||
| 97743164 | 9774316 | 6 | 20130919 | 0 | ||
| 97743164 | 9774316 | 7 | 20131003 | 0 | ||
| 97743164 | 9774316 | 8 | 20131031 | 0 | ||
| 97743164 | 9774316 | 9 | 20140206 | 0 | ||
| 97743164 | 9774316 | 10 | 20160818 | 0 | ||
| 97743164 | 9774316 | 11 | 20160901 | 0 |