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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103591366 | 10359136 | 6 | F | 20160913 | 20140804 | 20160921 | EXP | CA-ROCHE-1444820 | ROCHE | 0.00 | F | Y | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103591366 | 10359136 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, EVERY 4 WEEKS | U | 103976 | 300 | MG | SOLUTION FOR INJECTION | ||||||
| 103591366 | 10359136 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | 103976 | SOLUTION FOR INJECTION | ||||||||
| 103591366 | 10359136 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | 103976 | 300 | MG | SOLUTION FOR INJECTION | QOW | ||||||
| 103591366 | 10359136 | 4 | SS | VALSARTAN. | VALSARTAN | 1 | Oral | U | 0 | 160 | MG | QD | |||||||
| 103591366 | 10359136 | 5 | SS | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Unknown | U | 0 | ||||||||||
| 103591366 | 10359136 | 6 | C | ALVESCO | CICLESONIDE | 1 | Unknown | U | 0 | ||||||||||
| 103591366 | 10359136 | 7 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 103591366 | 10359136 | 8 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 103591366 | 10359136 | 9 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103591366 | 10359136 | 1 | Asthma |
| 103591366 | 10359136 | 4 | Product used for unknown indication |
| 103591366 | 10359136 | 5 | Pneumonia |
| 103591366 | 10359136 | 6 | Product used for unknown indication |
| 103591366 | 10359136 | 7 | Product used for unknown indication |
| 103591366 | 10359136 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 103591366 | 10359136 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103591366 | 10359136 | Asthmatic crisis | |
| 103591366 | 10359136 | Cataract | |
| 103591366 | 10359136 | Chest discomfort | |
| 103591366 | 10359136 | Cough | |
| 103591366 | 10359136 | Decreased activity | |
| 103591366 | 10359136 | Dyspnoea | |
| 103591366 | 10359136 | Fatigue | |
| 103591366 | 10359136 | Gait disturbance | |
| 103591366 | 10359136 | General physical health deterioration | |
| 103591366 | 10359136 | Malaise | |
| 103591366 | 10359136 | Pneumonia | |
| 103591366 | 10359136 | 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 |
|---|---|---|---|---|---|---|
| 103591366 | 10359136 | 1 | 20070518 | 201304 | 0 | |
| 103591366 | 10359136 | 2 | 201304 | 201304 | 0 | |
| 103591366 | 10359136 | 3 | 20160913 | 0 |