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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108606375 | 10860637 | 5 | F | 20130923 | 20160623 | 20150224 | 20160701 | EXP | CA-ROCHE-1542745 | ROCHE | 48.09 | YR | F | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108606375 | 10860637 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | Y | S0058A,S0068D | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 108606375 | 10860637 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | S0058A,S0068D | 103976 | ||||||||
| 108606375 | 10860637 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | S0058A,S0068D | 103976 | ||||||||
| 108606375 | 10860637 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | S0058A,S0068D | 103976 | ||||||||
| 108606375 | 10860637 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | S0058A,S0068D | 103976 | ||||||||
| 108606375 | 10860637 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | S0058A,S0068D | 103976 | ||||||||
| 108606375 | 10860637 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | S0058A,S0068D | 103976 | ||||||||
| 108606375 | 10860637 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | Y | S0058A,S0068D | 103976 | |||||||||
| 108606375 | 10860637 | 9 | SS | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | Unknown | 375 MG, BIW | 0 | 375 | MG | QOW | |||||||
| 108606375 | 10860637 | 10 | SS | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 108606375 | 10860637 | 11 | SS | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 108606375 | 10860637 | 12 | SS | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 108606375 | 10860637 | 13 | SS | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 108606375 | 10860637 | 14 | SS | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 108606375 | 10860637 | 15 | SS | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 108606375 | 10860637 | 16 | SS | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 108606375 | 10860637 | 17 | C | ALVESCO | CICLESONIDE | 1 | Respiratory (inhalation) | 2 DF, BID | U | 0 | 2 | DF | BID | ||||||
| 108606375 | 10860637 | 18 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Respiratory (inhalation) | 1 DF, QD | U | 0 | 1 | DF | QD | ||||||
| 108606375 | 10860637 | 19 | C | NASONEX | MOMETASONE FUROATE | 1 | Respiratory (inhalation) | 2 DF, BID | U | 0 | 2 | DF | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108606375 | 10860637 | 1 | Asthma |
| 108606375 | 10860637 | 9 | Product used for unknown indication |
| 108606375 | 10860637 | 17 | Product used for unknown indication |
| 108606375 | 10860637 | 18 | Product used for unknown indication |
| 108606375 | 10860637 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108606375 | 10860637 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108606375 | 10860637 | Aphonia | |
| 108606375 | 10860637 | Arthralgia | |
| 108606375 | 10860637 | Blood pressure increased | |
| 108606375 | 10860637 | Bronchitis | |
| 108606375 | 10860637 | Diarrhoea | |
| 108606375 | 10860637 | Fall | |
| 108606375 | 10860637 | Fatigue | |
| 108606375 | 10860637 | Haematoma | |
| 108606375 | 10860637 | Influenza | |
| 108606375 | 10860637 | Injection site haematoma | |
| 108606375 | 10860637 | Laryngitis | |
| 108606375 | 10860637 | Ligament sprain | |
| 108606375 | 10860637 | Lower respiratory tract congestion | |
| 108606375 | 10860637 | Nasopharyngitis | |
| 108606375 | 10860637 | Oropharyngeal pain | |
| 108606375 | 10860637 | Pain in extremity | |
| 108606375 | 10860637 | Paronychia | |
| 108606375 | 10860637 | Rhinorrhoea | |
| 108606375 | 10860637 | Sinus pain | |
| 108606375 | 10860637 | Sinusitis | |
| 108606375 | 10860637 | Sputum discoloured | |
| 108606375 | 10860637 | Torticollis | |
| 108606375 | 10860637 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 108606375 | 10860637 | 1 | 20130814 | 0 | ||
| 108606375 | 10860637 | 2 | 20130827 | 0 | ||
| 108606375 | 10860637 | 3 | 20130923 | 0 | ||
| 108606375 | 10860637 | 4 | 20131104 | 0 | ||
| 108606375 | 10860637 | 5 | 20131230 | 0 | ||
| 108606375 | 10860637 | 6 | 20141229 | 0 | ||
| 108606375 | 10860637 | 7 | 20160108 | 0 | ||
| 108606375 | 10860637 | 8 | 20160614 | 20160614 | 0 | |
| 108606375 | 10860637 | 9 | 20130814 | 0 | ||
| 108606375 | 10860637 | 10 | 20130827 | 0 | ||
| 108606375 | 10860637 | 11 | 20130923 | 0 | ||
| 108606375 | 10860637 | 12 | 20131104 | 0 | ||
| 108606375 | 10860637 | 13 | 20131230 | 0 | ||
| 108606375 | 10860637 | 14 | 20141229 | 0 | ||
| 108606375 | 10860637 | 15 | 20160108 | 0 | ||
| 108606375 | 10860637 | 16 | 20160614 | 20160614 | 0 |