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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114673818 | 11467381 | 8 | F | 20140903 | 20160708 | 20150908 | 20160718 | EXP | CA-ROCHE-1631126 | ROCHE | 72.19 | YR | M | Y | 112.00000 | KG | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114673818 | 11467381 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW (EVERY 2 WEEKS) | U | S0060A,S0066B,S0001E | 103976 | 375 | MG | QOW | |||||
| 114673818 | 11467381 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A,S0066B,S0001E | 103976 | ||||||||
| 114673818 | 11467381 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A,S0066B,S0001E | 103976 | 375 | MG | QOW | |||||
| 114673818 | 11467381 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A,S0066B,S0001E | 103976 | ||||||||
| 114673818 | 11467381 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A,S0066B,S0001E | 103976 | ||||||||
| 114673818 | 11467381 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A,S0066B,S0001E | 103976 | ||||||||
| 114673818 | 11467381 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A,S0066B,S0001E | 103976 | ||||||||
| 114673818 | 11467381 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A,S0066B,S0001E | 103976 | ||||||||
| 114673818 | 11467381 | 9 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 114673818 | 11467381 | 10 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 114673818 | 11467381 | 11 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 114673818 | 11467381 | 12 | C | AVAMYS | FLUTICASONE FUROATE | 1 | Unknown | U | 0 | ||||||||||
| 114673818 | 11467381 | 13 | C | INSULIN | INSULIN NOS | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114673818 | 11467381 | 1 | Asthma |
| 114673818 | 11467381 | 9 | Product used for unknown indication |
| 114673818 | 11467381 | 10 | Product used for unknown indication |
| 114673818 | 11467381 | 11 | Product used for unknown indication |
| 114673818 | 11467381 | 12 | Product used for unknown indication |
| 114673818 | 11467381 | 13 | Type 2 diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114673818 | 11467381 | OT |
| 114673818 | 11467381 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114673818 | 11467381 | Blood pressure systolic increased | |
| 114673818 | 11467381 | Drug ineffective | |
| 114673818 | 11467381 | Fall | |
| 114673818 | 11467381 | Heart rate increased | |
| 114673818 | 11467381 | Hypoglycaemia | |
| 114673818 | 11467381 | Lower respiratory tract infection | |
| 114673818 | 11467381 | Pneumonia | |
| 114673818 | 11467381 | Poor quality sleep | |
| 114673818 | 11467381 | Pruritus | |
| 114673818 | 11467381 | Pruritus generalised | |
| 114673818 | 11467381 | Pulmonary congestion | |
| 114673818 | 11467381 | Respiratory disorder | |
| 114673818 | 11467381 | Respiratory rate increased | |
| 114673818 | 11467381 | Seizure | |
| 114673818 | 11467381 | Suffocation feeling | |
| 114673818 | 11467381 | Weight decreased | |
| 114673818 | 11467381 | 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 |
|---|---|---|---|---|---|---|
| 114673818 | 11467381 | 1 | 20140903 | 0 | ||
| 114673818 | 11467381 | 2 | 20141126 | 0 | ||
| 114673818 | 11467381 | 3 | 20150305 | 0 | ||
| 114673818 | 11467381 | 4 | 20150902 | 0 | ||
| 114673818 | 11467381 | 5 | 20141015 | 0 | ||
| 114673818 | 11467381 | 6 | 20160205 | 0 | ||
| 114673818 | 11467381 | 7 | 20160511 | 0 | ||
| 114673818 | 11467381 | 8 | 20160608 | 0 |