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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118492873 | 11849287 | 3 | F | 20140319 | 20160715 | 20151218 | 20160720 | EXP | CA-ROCHE-1679159 | ROCHE | 16.39 | YR | F | Y | 0.00000 | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118492873 | 11849287 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW (EVERY 2 WEEKS) | U | S0001E,S0047C,S0002F | 103976 | 375 | MG | QOW | |||||
| 118492873 | 11849287 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0001E,S0047C,S0002F | 103976 | ||||||||
| 118492873 | 11849287 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0001E,S0047C,S0002F | 103976 | ||||||||
| 118492873 | 11849287 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0001E,S0047C,S0002F | 103976 | ||||||||
| 118492873 | 11849287 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0001E,S0047C,S0002F | 103976 | ||||||||
| 118492873 | 11849287 | 6 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118492873 | 11849287 | 1 | Asthma |
| 118492873 | 11849287 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118492873 | 11849287 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118492873 | 11849287 | Anxiety | |
| 118492873 | 11849287 | Body temperature decreased | |
| 118492873 | 11849287 | Condition aggravated | |
| 118492873 | 11849287 | Cystic fibrosis | |
| 118492873 | 11849287 | Fatigue | |
| 118492873 | 11849287 | Feeling abnormal | |
| 118492873 | 11849287 | Oxygen saturation decreased |
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 |
|---|---|---|---|---|---|---|
| 118492873 | 11849287 | 1 | 20140319 | 0 | ||
| 118492873 | 11849287 | 2 | 20160503 | 0 | ||
| 118492873 | 11849287 | 3 | 20160518 | 0 | ||
| 118492873 | 11849287 | 4 | 20160629 | 0 | ||
| 118492873 | 11849287 | 5 | 20160715 | 0 |