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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111343088 | 11134308 | 8 | F | 20150323 | 20160817 | 20150525 | 20160822 | EXP | CA-ROCHE-1581598 | ROCHE | 12.34 | YR | F | Y | 57.00000 | KG | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111343088 | 11134308 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0062,S0066B,S0001E,S0068D | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 111343088 | 11134308 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0062,S0066B,S0001E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111343088 | 11134308 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0062,S0066B,S0001E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111343088 | 11134308 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0062,S0066B,S0001E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111343088 | 11134308 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0062,S0066B,S0001E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111343088 | 11134308 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0062,S0066B,S0001E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111343088 | 11134308 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0062,S0066B,S0001E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111343088 | 11134308 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0062,S0062,S0066B,S0001E,S0068D | 103976 | SOLUTION FOR INJECTION | ||||||||
| 111343088 | 11134308 | 9 | C | ASMANEX | MOMETASONE FUROATE | 1 | Unknown | U | 0 | ||||||||||
| 111343088 | 11134308 | 10 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 111343088 | 11134308 | 11 | C | CLARITIN | LORATADINE | 1 | Unknown | U | 0 | ||||||||||
| 111343088 | 11134308 | 12 | C | BRICANYL | TERBUTALINE SULFATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111343088 | 11134308 | 1 | Asthma |
| 111343088 | 11134308 | 9 | Product used for unknown indication |
| 111343088 | 11134308 | 10 | Product used for unknown indication |
| 111343088 | 11134308 | 11 | Product used for unknown indication |
| 111343088 | 11134308 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111343088 | 11134308 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111343088 | 11134308 | Asthma | |
| 111343088 | 11134308 | Body temperature decreased | |
| 111343088 | 11134308 | Cough | |
| 111343088 | 11134308 | Food allergy | |
| 111343088 | 11134308 | Gastric disorder | |
| 111343088 | 11134308 | Gastrooesophageal reflux disease | |
| 111343088 | 11134308 | Headache | |
| 111343088 | 11134308 | Heart rate increased | |
| 111343088 | 11134308 | Hypersensitivity | |
| 111343088 | 11134308 | Oropharyngeal pain | |
| 111343088 | 11134308 | Pneumonia | |
| 111343088 | 11134308 | Respiratory rate increased | |
| 111343088 | 11134308 | Urticaria | |
| 111343088 | 11134308 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 111343088 | 11134308 | 1 | 20131210 | 0 | ||
| 111343088 | 11134308 | 2 | 20150407 | 0 | ||
| 111343088 | 11134308 | 3 | 20160310 | 0 | ||
| 111343088 | 11134308 | 4 | 20160324 | 0 | ||
| 111343088 | 11134308 | 5 | 20160427 | 0 | ||
| 111343088 | 11134308 | 6 | 20160602 | 0 | ||
| 111343088 | 11134308 | 7 | 20160804 | 0 | ||
| 111343088 | 11134308 | 8 | 20160817 | 0 |