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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117198127 | 11719812 | 7 | F | 20150414 | 20160831 | 20151110 | 20160907 | EXP | CA-ROCHE-1657571 | ROCHE | 40.95 | YR | M | Y | 0.00000 | 20160908 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117198127 | 11719812 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E,S0003B | 103976 | 300 | MG | SOLUTION FOR INJECTION | ||||||
| 117198127 | 11719812 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117198127 | 11719812 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117198127 | 11719812 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117198127 | 11719812 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117198127 | 11719812 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117198127 | 11719812 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117198127 | 11719812 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117198127 | 11719812 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117198127 | 11719812 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117198127 | 11719812 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117198127 | 11719812 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117198127 | 11719812 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0001E,S0003B | 103976 | SOLUTION FOR INJECTION | ||||||||
| 117198127 | 11719812 | 14 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 117198127 | 11719812 | 15 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 117198127 | 11719812 | 16 | C | DILANTIN | PHENYTOIN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117198127 | 11719812 | 1 | Asthma |
| 117198127 | 11719812 | 14 | Product used for unknown indication |
| 117198127 | 11719812 | 15 | Product used for unknown indication |
| 117198127 | 11719812 | 16 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117198127 | 11719812 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117198127 | 11719812 | Blood pressure increased | |
| 117198127 | 11719812 | Dyspnoea | |
| 117198127 | 11719812 | Heart rate increased | |
| 117198127 | 11719812 | Nasopharyngitis | |
| 117198127 | 11719812 | Respiratory disorder | |
| 117198127 | 11719812 | Weight increased | |
| 117198127 | 11719812 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 117198127 | 11719812 | 1 | 20150312 | 0 | ||
| 117198127 | 11719812 | 2 | 20150414 | 0 | ||
| 117198127 | 11719812 | 3 | 20150507 | 0 | ||
| 117198127 | 11719812 | 4 | 20150604 | 0 | ||
| 117198127 | 11719812 | 5 | 20150702 | 0 | ||
| 117198127 | 11719812 | 6 | 20150730 | 0 | ||
| 117198127 | 11719812 | 7 | 20151001 | 0 | ||
| 117198127 | 11719812 | 8 | 20151029 | 0 | ||
| 117198127 | 11719812 | 9 | 20151126 | 0 | ||
| 117198127 | 11719812 | 10 | 20151224 | 0 | ||
| 117198127 | 11719812 | 11 | 20160121 | 0 | ||
| 117198127 | 11719812 | 12 | 20160512 | 0 | ||
| 117198127 | 11719812 | 13 | 20160831 | 0 |