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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125760402 | 12576040 | 2 | F | 20140605 | 20160815 | 20160720 | 20160818 | EXP | PHHY2014CA071909 | NOVARTIS | 67.10 | YR | M | Y | 0.00000 | 20160818 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125760402 | 12576040 | 1 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW (EVERY 2 WEEKS) | U | 0 | 375 | MG | QOW | ||||||
| 125760402 | 12576040 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 0 | ||||||||||
| 125760402 | 12576040 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 0 | ||||||||||
| 125760402 | 12576040 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 0 | ||||||||||
| 125760402 | 12576040 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 225 MG, UNK | U | 0 | 225 | MG | |||||||
| 125760402 | 12576040 | 6 | PS | VOLTAREN | DICLOFENAC SODIUM | 1 | Unknown | U | 19201 | ||||||||||
| 125760402 | 12576040 | 7 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | ADITIONAL DOSE ONCE OR TWICE A DAY FOR THE LAST 8 MONTHS | U | 0 | |||||||||
| 125760402 | 12576040 | 8 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 1 COURSE IN THE PAST YEAR | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125760402 | 12576040 | 1 | Asthma |
| 125760402 | 12576040 | 6 | Product used for unknown indication |
| 125760402 | 12576040 | 7 | Product used for unknown indication |
| 125760402 | 12576040 | 8 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125760402 | 12576040 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125760402 | 12576040 | Asthma | |
| 125760402 | 12576040 | Body temperature decreased | |
| 125760402 | 12576040 | Drug hypersensitivity | |
| 125760402 | 12576040 | Forced expiratory volume decreased | |
| 125760402 | 12576040 | Incorrect dose administered |
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 |
|---|---|---|---|---|---|---|
| 125760402 | 12576040 | 1 | 20070110 | 0 | ||
| 125760402 | 12576040 | 2 | 20140605 | 0 | ||
| 125760402 | 12576040 | 3 | 20140618 | 0 | ||
| 125760402 | 12576040 | 4 | 20150212 | 0 | ||
| 125760402 | 12576040 | 5 | 20151111 | 0 |