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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118300956 | 11830095 | 6 | F | 201504 | 20160923 | 20151214 | 20160929 | EXP | CA-ROCHE-1676022 | ROCHE | 80.51 | YR | M | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118300956 | 11830095 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 118300956 | 11830095 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 118300956 | 11830095 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 14 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 15 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 16 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 17 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 18 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0060A,S0060A,S0065E,S0066B,S0002F, | 103976 | SOLUTION FOR INJECTION | ||||||||
| 118300956 | 11830095 | 19 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 118300956 | 11830095 | 20 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 118300956 | 11830095 | 21 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 118300956 | 11830095 | 22 | C | RHINOCORT | BUDESONIDE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118300956 | 11830095 | 1 | Asthma |
| 118300956 | 11830095 | 19 | Product used for unknown indication |
| 118300956 | 11830095 | 20 | Product used for unknown indication |
| 118300956 | 11830095 | 21 | Product used for unknown indication |
| 118300956 | 11830095 | 22 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118300956 | 11830095 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118300956 | 11830095 | Arthralgia | |
| 118300956 | 11830095 | Blood pressure systolic increased | |
| 118300956 | 11830095 | Chills | |
| 118300956 | 11830095 | Dizziness | |
| 118300956 | 11830095 | Dyspnoea exertional | |
| 118300956 | 11830095 | Insomnia | |
| 118300956 | 11830095 | Lower respiratory tract congestion | |
| 118300956 | 11830095 | Nasopharyngitis | |
| 118300956 | 11830095 | Pain in extremity | |
| 118300956 | 11830095 | Pneumonia | |
| 118300956 | 11830095 | Productive cough | |
| 118300956 | 11830095 | Respiratory tract infection | |
| 118300956 | 11830095 | Tremor | |
| 118300956 | 11830095 | 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 |
|---|---|---|---|---|---|---|
| 118300956 | 11830095 | 1 | 20150312 | 0 | ||
| 118300956 | 11830095 | 2 | 20150520 | 0 | ||
| 118300956 | 11830095 | 3 | 20150923 | 0 | ||
| 118300956 | 11830095 | 4 | 20151202 | 0 | ||
| 118300956 | 11830095 | 5 | 20151230 | 0 | ||
| 118300956 | 11830095 | 6 | 20160113 | 0 | ||
| 118300956 | 11830095 | 7 | 20160127 | 0 | ||
| 118300956 | 11830095 | 8 | 20160224 | 0 | ||
| 118300956 | 11830095 | 9 | 20160309 | 0 | ||
| 118300956 | 11830095 | 10 | 20160420 | 0 | ||
| 118300956 | 11830095 | 11 | 20160504 | 0 | ||
| 118300956 | 11830095 | 12 | 20160504 | 0 | ||
| 118300956 | 11830095 | 13 | 20160629 | 0 | ||
| 118300956 | 11830095 | 14 | 20160714 | 0 | ||
| 118300956 | 11830095 | 15 | 20160810 | 0 | ||
| 118300956 | 11830095 | 16 | 20160823 | 0 | ||
| 118300956 | 11830095 | 17 | 20160907 | 0 | ||
| 118300956 | 11830095 | 18 | 20160923 | 0 |