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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113938666 | 11393866 | 6 | F | 20160812 | 20150819 | 20160823 | EXP | CA-ROCHE-1622898 | ROCHE | 0.00 | F | Y | 0.00000 | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113938666 | 11393866 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | U | S0065E,S0001E | 103976 | 225 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 113938666 | 11393866 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0001E | 103976 | SOLUTION FOR INJECTION | |||||||
| 113938666 | 11393866 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0001E | 103976 | SOLUTION FOR INJECTION | |||||||
| 113938666 | 11393866 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0001E | 103976 | SOLUTION FOR INJECTION | |||||||
| 113938666 | 11393866 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0065E,S0001E | 103976 | SOLUTION FOR INJECTION | |||||||
| 113938666 | 11393866 | 6 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 113938666 | 11393866 | 7 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 113938666 | 11393866 | 8 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 113938666 | 11393866 | 9 | C | REACTINE (CANADA) | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 113938666 | 11393866 | 10 | C | BECONASE AQ | BECLOMETHASONE DIPROPIONATE MONOHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 113938666 | 11393866 | 11 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 113938666 | 11393866 | 12 | C | PANTOLOC | PANTOPRAZOLE SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 113938666 | 11393866 | 13 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | U | 0 | ||||||||||
| 113938666 | 11393866 | 14 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113938666 | 11393866 | 1 | Asthma |
| 113938666 | 11393866 | 6 | Product used for unknown indication |
| 113938666 | 11393866 | 7 | Product used for unknown indication |
| 113938666 | 11393866 | 8 | Product used for unknown indication |
| 113938666 | 11393866 | 9 | Product used for unknown indication |
| 113938666 | 11393866 | 10 | Product used for unknown indication |
| 113938666 | 11393866 | 11 | Product used for unknown indication |
| 113938666 | 11393866 | 12 | Product used for unknown indication |
| 113938666 | 11393866 | 13 | Product used for unknown indication |
| 113938666 | 11393866 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113938666 | 11393866 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113938666 | 11393866 | Anaphylactic reaction | |
| 113938666 | 11393866 | Asthenia | |
| 113938666 | 11393866 | Back pain | |
| 113938666 | 11393866 | Diarrhoea | |
| 113938666 | 11393866 | Dyspnoea | |
| 113938666 | 11393866 | Fatigue | |
| 113938666 | 11393866 | Forced expiratory volume decreased | |
| 113938666 | 11393866 | Functional gastrointestinal disorder | |
| 113938666 | 11393866 | Gastric dilatation | |
| 113938666 | 11393866 | Hypoventilation | |
| 113938666 | 11393866 | Middle insomnia | |
| 113938666 | 11393866 | Muscular weakness | |
| 113938666 | 11393866 | Productive cough | |
| 113938666 | 11393866 | Sputum discoloured | |
| 113938666 | 11393866 | 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 |
|---|---|---|---|---|---|---|
| 113938666 | 11393866 | 1 | 20150810 | 0 | ||
| 113938666 | 11393866 | 2 | 20160418 | 0 | ||
| 113938666 | 11393866 | 3 | 20160615 | 0 | ||
| 113938666 | 11393866 | 4 | 20160628 | 0 | ||
| 113938666 | 11393866 | 5 | 20160714 | 0 |