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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119594636 | 11959463 | 6 | F | 20160102 | 20160707 | 20160126 | 20160715 | EXP | CA-ROCHE-1698185 | ROCHE | 58.88 | YR | M | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119594636 | 11959463 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0062,S0065E | 103976 | 300 | MG | SOLUTION FOR INJECTION | ||||||
| 119594636 | 11959463 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0062,S0065E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119594636 | 11959463 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0062,S0065E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119594636 | 11959463 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0062,S0065E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119594636 | 11959463 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0062,S0065E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119594636 | 11959463 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0062,S0065E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119594636 | 11959463 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0062,S0065E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119594636 | 11959463 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A,S0062,S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 119594636 | 11959463 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0062,S0065E | 103976 | SOLUTION FOR INJECTION | ||||||||
| 119594636 | 11959463 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A,S0062,S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 119594636 | 11959463 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A,S0062,S0065E | 103976 | SOLUTION FOR INJECTION | |||||||
| 119594636 | 11959463 | 12 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 119594636 | 11959463 | 13 | C | PULMICORT TURBUHALER | BUDESONIDE | 1 | Unknown | U | 0 | ||||||||||
| 119594636 | 11959463 | 14 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119594636 | 11959463 | 1 | Asthma |
| 119594636 | 11959463 | 12 | Product used for unknown indication |
| 119594636 | 11959463 | 13 | Product used for unknown indication |
| 119594636 | 11959463 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119594636 | 11959463 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119594636 | 11959463 | Body temperature decreased | |
| 119594636 | 11959463 | Dyspnoea | |
| 119594636 | 11959463 | Fall | |
| 119594636 | 11959463 | Haemorrhage | |
| 119594636 | 11959463 | Increased upper airway secretion | |
| 119594636 | 11959463 | Lower respiratory tract infection | |
| 119594636 | 11959463 | Nasopharyngitis | |
| 119594636 | 11959463 | Skeletal injury | |
| 119594636 | 11959463 | Upper respiratory tract infection | |
| 119594636 | 11959463 | 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 |
|---|---|---|---|---|---|---|
| 119594636 | 11959463 | 1 | 20120905 | 0 | ||
| 119594636 | 11959463 | 2 | 20130705 | 0 | ||
| 119594636 | 11959463 | 3 | 20131010 | 0 | ||
| 119594636 | 11959463 | 4 | 20140206 | 0 | ||
| 119594636 | 11959463 | 5 | 20160115 | 0 | ||
| 119594636 | 11959463 | 6 | 20160212 | 0 | ||
| 119594636 | 11959463 | 7 | 20160315 | 0 | ||
| 119594636 | 11959463 | 8 | 20160415 | 0 | ||
| 119594636 | 11959463 | 9 | 20160513 | 0 | ||
| 119594636 | 11959463 | 10 | 20160610 | 0 | ||
| 119594636 | 11959463 | 11 | 20160707 | 0 |