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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118849495 | 11884949 | 5 | F | 20131223 | 20160825 | 20160104 | 20160831 | EXP | CA-ROCHE-1164835 | ROCHE | 65.73 | YR | F | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118849495 | 11884949 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S0001E | 103976 | 225 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 118849495 | 11884949 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118849495 | 11884949 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S0001E | 103976 | 225 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 118849495 | 11884949 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118849495 | 11884949 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118849495 | 11884949 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118849495 | 11884949 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118849495 | 11884949 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118849495 | 11884949 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118849495 | 11884949 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118849495 | 11884949 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118849495 | 11884949 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S0001E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118849495 | 11884949 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S0001E | 103976 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118849495 | 11884949 | 1 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118849495 | 11884949 | HO |
| 118849495 | 11884949 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118849495 | 11884949 | Asthma | |
| 118849495 | 11884949 | Blood pressure diastolic decreased | |
| 118849495 | 11884949 | Blood pressure increased | |
| 118849495 | 11884949 | Body temperature decreased | |
| 118849495 | 11884949 | Breast cancer recurrent | |
| 118849495 | 11884949 | Dyspnoea | |
| 118849495 | 11884949 | Fatigue | |
| 118849495 | 11884949 | Nervousness | |
| 118849495 | 11884949 | Tachycardia |
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 |
|---|---|---|---|---|---|---|
| 118849495 | 11884949 | 1 | 20101129 | 0 | ||
| 118849495 | 11884949 | 2 | 20121017 | 0 | ||
| 118849495 | 11884949 | 3 | 20121128 | 0 | ||
| 118849495 | 11884949 | 4 | 20131223 | 0 | ||
| 118849495 | 11884949 | 5 | 20141203 | 0 | ||
| 118849495 | 11884949 | 6 | 20150128 | 0 | ||
| 118849495 | 11884949 | 7 | 20150225 | 0 | ||
| 118849495 | 11884949 | 8 | 20150715 | 0 | ||
| 118849495 | 11884949 | 9 | 20151229 | 0 | ||
| 118849495 | 11884949 | 10 | 20160420 | 0 | ||
| 118849495 | 11884949 | 11 | 20160519 | 0 | ||
| 118849495 | 11884949 | 12 | 20160602 | 0 | ||
| 118849495 | 11884949 | 13 | 20160616 | 0 |