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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 96394484 | 9639448 | 4 | F | 20130114 | 20160915 | 20131022 | 20160923 | EXP | CA-ROCHE-1291711 | ROCHE | 64.34 | YR | M | Y | 0.00000 | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 96394484 | 9639448 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, EVERY 3 WEEKS | U | S0066B,S0003B | 103976 | 375 | MG | SOLUTION FOR INJECTION | Q3W | ||||
| 96394484 | 9639448 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0066B,S0003B | 103976 | SOLUTION FOR INJECTION | |||||||
| 96394484 | 9639448 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0066B,S0003B | 103976 | SOLUTION FOR INJECTION | |||||||
| 96394484 | 9639448 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0066B,S0003B | 103976 | SOLUTION FOR INJECTION | |||||||
| 96394484 | 9639448 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0066B,S0003B | 103976 | SOLUTION FOR INJECTION | |||||||
| 96394484 | 9639448 | 6 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 96394484 | 9639448 | 7 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 96394484 | 9639448 | 1 | Asthma |
| 96394484 | 9639448 | 6 | Product used for unknown indication |
| 96394484 | 9639448 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 96394484 | 9639448 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 96394484 | 9639448 | Asthma | |
| 96394484 | 9639448 | Blood pressure increased | |
| 96394484 | 9639448 | Forced expiratory volume decreased | |
| 96394484 | 9639448 | Musculoskeletal pain | |
| 96394484 | 9639448 | Nasal polyps | |
| 96394484 | 9639448 | Pain in extremity | |
| 96394484 | 9639448 | Rales | |
| 96394484 | 9639448 | Sinus congestion | |
| 96394484 | 9639448 | Sinus polyp |
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 |
|---|---|---|---|---|---|---|
| 96394484 | 9639448 | 1 | 20110107 | 0 | ||
| 96394484 | 9639448 | 2 | 20130320 | 0 | ||
| 96394484 | 9639448 | 3 | 20131015 | 0 | ||
| 96394484 | 9639448 | 4 | 20160511 | 0 | ||
| 96394484 | 9639448 | 5 | 20160712 | 0 |