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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1004588022 | 10045880 | 22 | F | 20140123 | 20160622 | 20140329 | 20160630 | EXP | CA-ROCHE-1370824 | ROCHE | 48.51 | YR | M | Y | 0.00000 | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1004588022 | 10045880 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0062,S0066B,S0001E | 103976 | 150 | MG | SOLUTION FOR INJECTION | |||||||
| 1004588022 | 10045880 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0062,S0066B,S0001E | 103976 | 150 | MG | SOLUTION FOR INJECTION | |||||||
| 1004588022 | 10045880 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0062,S0066B,S0001E | 103976 | ||||||||||
| 1004588022 | 10045880 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0062,S0066B,S0001E | 103976 | ||||||||||
| 1004588022 | 10045880 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0062,S0066B,S0001E | 103976 | ||||||||||
| 1004588022 | 10045880 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0062,S0066B,S0001E | 103976 | ||||||||||
| 1004588022 | 10045880 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0062,S0066B,S0001E | 103976 | ||||||||||
| 1004588022 | 10045880 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0062,S0066B,S0001E | 103976 | ||||||||||
| 1004588022 | 10045880 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0062,S0066B,S0001E | 103976 | ||||||||||
| 1004588022 | 10045880 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0062,S0066B,S0001E | 103976 | ||||||||||
| 1004588022 | 10045880 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0062,S0066B,S0001E | 103976 | ||||||||||
| 1004588022 | 10045880 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0062,S0066B,S0001E | 103976 | ||||||||||
| 1004588022 | 10045880 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0062,S0066B,S0001E | 103976 | ||||||||||
| 1004588022 | 10045880 | 14 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | 0 | |||||||||||
| 1004588022 | 10045880 | 15 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | 0 | |||||||||||
| 1004588022 | 10045880 | 16 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Respiratory (inhalation) | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1004588022 | 10045880 | 1 | Asthma |
| 1004588022 | 10045880 | 14 | Product used for unknown indication |
| 1004588022 | 10045880 | 15 | Product used for unknown indication |
| 1004588022 | 10045880 | 16 | Dyspnoea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1004588022 | 10045880 | HO |
| 1004588022 | 10045880 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1004588022 | 10045880 | Anxiety | |
| 1004588022 | 10045880 | Asthma | |
| 1004588022 | 10045880 | Blood pressure increased | |
| 1004588022 | 10045880 | Body temperature decreased | |
| 1004588022 | 10045880 | Condition aggravated | |
| 1004588022 | 10045880 | Dyspnoea | |
| 1004588022 | 10045880 | Dyspnoea exertional | |
| 1004588022 | 10045880 | Environmental exposure | |
| 1004588022 | 10045880 | Hypoventilation | |
| 1004588022 | 10045880 | Insomnia | |
| 1004588022 | 10045880 | Lung disorder | |
| 1004588022 | 10045880 | Malaise | |
| 1004588022 | 10045880 | Muscle spasms | |
| 1004588022 | 10045880 | Nasal congestion | |
| 1004588022 | 10045880 | Pneumonia | |
| 1004588022 | 10045880 | Rales | |
| 1004588022 | 10045880 | Respiratory disorder | |
| 1004588022 | 10045880 | Respiratory distress | |
| 1004588022 | 10045880 | Tachycardia | |
| 1004588022 | 10045880 | Throat irritation | |
| 1004588022 | 10045880 | 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 |
|---|---|---|---|---|---|---|
| 1004588022 | 10045880 | 1 | 20140123 | 0 | ||
| 1004588022 | 10045880 | 2 | 20140319 | 0 | ||
| 1004588022 | 10045880 | 3 | 20140611 | 0 | ||
| 1004588022 | 10045880 | 4 | 20150128 | 0 | ||
| 1004588022 | 10045880 | 5 | 20150326 | 0 | ||
| 1004588022 | 10045880 | 6 | 20150520 | 0 | ||
| 1004588022 | 10045880 | 7 | 20150716 | 0 | ||
| 1004588022 | 10045880 | 8 | 20150812 | 0 | ||
| 1004588022 | 10045880 | 9 | 20151209 | 0 | ||
| 1004588022 | 10045880 | 10 | 20160330 | 0 | ||
| 1004588022 | 10045880 | 11 | 20160427 | 0 | ||
| 1004588022 | 10045880 | 12 | 20160525 | 0 | ||
| 1004588022 | 10045880 | 13 | 20160622 | 0 |