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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113599476 | 11359947 | 6 | F | 201408 | 20160811 | 20150810 | 20160818 | EXP | CA-ROCHE-1618640 | ROCHE | 80.69 | YR | F | Y | 0.00000 | 20160818 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113599476 | 11359947 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 150 MG, EVERY 4 WEEKS | U | S0065E | 103976 | 150 | MG | SOLUTION FOR INJECTION | |||||
| 113599476 | 11359947 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 113599476 | 11359947 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 113599476 | 11359947 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 113599476 | 11359947 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 113599476 | 11359947 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 113599476 | 11359947 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 113599476 | 11359947 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 113599476 | 11359947 | 9 | SS | DIOVAN | VALSARTAN | 1 | Unknown | UNK | U | 0 | |||||||||
| 113599476 | 11359947 | 10 | SS | METOPROLOL. | METOPROLOL | 1 | Unknown | 50 MG | U | 0 | 50 | MG | |||||||
| 113599476 | 11359947 | 11 | C | APO CANDESARTAN | 2 | Unknown | 4 MG, UNK | U | 0 | 4 | MG | ||||||||
| 113599476 | 11359947 | 12 | C | AMLODIPINE BESILATE | AMLODIPINE BESYLATE | 1 | Unknown | 2.5 MG | U | 0 | 2.5 | MG | |||||||
| 113599476 | 11359947 | 13 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | UNK, PRN | U | 0 | |||||||||
| 113599476 | 11359947 | 14 | C | FLOVENT | FLUTICASONE PROPIONATE | 1 | Unknown | UNK UNK, QID | U | 0 | QID | ||||||||
| 113599476 | 11359947 | 15 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | UNK UNK, QID | U | 0 | QID | ||||||||
| 113599476 | 11359947 | 16 | C | CANDESARTAN | CANDESARTAN | 1 | Unknown | U | 0 | ||||||||||
| 113599476 | 11359947 | 17 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113599476 | 11359947 | 1 | Asthma |
| 113599476 | 11359947 | 9 | Product used for unknown indication |
| 113599476 | 11359947 | 10 | Product used for unknown indication |
| 113599476 | 11359947 | 11 | Product used for unknown indication |
| 113599476 | 11359947 | 12 | Product used for unknown indication |
| 113599476 | 11359947 | 13 | Product used for unknown indication |
| 113599476 | 11359947 | 14 | Product used for unknown indication |
| 113599476 | 11359947 | 15 | Product used for unknown indication |
| 113599476 | 11359947 | 16 | Product used for unknown indication |
| 113599476 | 11359947 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113599476 | 11359947 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113599476 | 11359947 | Asthenia | |
| 113599476 | 11359947 | Asthma | |
| 113599476 | 11359947 | Blood pressure decreased | |
| 113599476 | 11359947 | Bronchitis | |
| 113599476 | 11359947 | Chest pain | |
| 113599476 | 11359947 | Cough | |
| 113599476 | 11359947 | Drug hypersensitivity | |
| 113599476 | 11359947 | Fatigue | |
| 113599476 | 11359947 | Feeling abnormal | |
| 113599476 | 11359947 | Hyperhidrosis | |
| 113599476 | 11359947 | Hypertension | |
| 113599476 | 11359947 | Influenza like illness | |
| 113599476 | 11359947 | Lethargy | |
| 113599476 | 11359947 | Malaise | |
| 113599476 | 11359947 | Nasal congestion | |
| 113599476 | 11359947 | Productive cough | |
| 113599476 | 11359947 | Rales | |
| 113599476 | 11359947 | Respiratory rate increased | |
| 113599476 | 11359947 | Seasonal allergy | |
| 113599476 | 11359947 | Sinus congestion | |
| 113599476 | 11359947 | Skin discolouration | |
| 113599476 | 11359947 | Tachycardia | |
| 113599476 | 11359947 | 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 |
|---|---|---|---|---|---|---|
| 113599476 | 11359947 | 1 | 20140703 | 0 | ||
| 113599476 | 11359947 | 2 | 20140828 | 0 | ||
| 113599476 | 11359947 | 3 | 20141218 | 0 | ||
| 113599476 | 11359947 | 4 | 20150115 | 0 | ||
| 113599476 | 11359947 | 5 | 20150730 | 0 | ||
| 113599476 | 11359947 | 6 | 20151030 | 0 | ||
| 113599476 | 11359947 | 7 | 20160421 | 0 | ||
| 113599476 | 11359947 | 8 | 20160519 | 0 |