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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 981979515 | 9819795 | 15 | F | 2007 | 20160627 | 20140116 | 20160707 | EXP | BR-ROCHE-1333990 | ROCHE | 43.10 | YR | F | Y | 61.00000 | KG | 20160707 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 981979515 | 9819795 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 1 DF, QMO (AMPOULE) | Y | S0003B,S0004,S0003,S0004B,S0003E,S0 | 103976 | 1 | DF | SOLUTION FOR INJECTION | /month | ||||
| 981979515 | 9819795 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 2 DF(AMPOULES), QMO | Y | S0003B,S0004,S0003,S0004B,S0003E,S0 | 103976 | 2 | DF | SOLUTION FOR INJECTION | /month | ||||
| 981979515 | 9819795 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 150 AMPOULES | Y | S0003B,S0004,S0003,S0004B,S0003E,S0 | 103976 | 2 | DF | SOLUTION FOR INJECTION | |||||
| 981979515 | 9819795 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 2 DF (150 MG AMPOULES) PER MONTH | Y | S0003B,S0004,S0003,S0004B,S0003E,S0 | 103976 | 2 | DF | SOLUTION FOR INJECTION | /month | ||||
| 981979515 | 9819795 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | S0003B,S0004,S0003,S0004B,S0003E,S0 | 103976 | 1 | DF | ||||||
| 981979515 | 9819795 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | S0003B,S0004,S0003,S0004B,S0003E,S0 | 103976 | SOLUTION FOR INJECTION | |||||||
| 981979515 | 9819795 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | S0003B,S0004,S0003,S0004B,S0003E,S0 | 103976 | 1 | DF | SOLUTION FOR INJECTION | |||||
| 981979515 | 9819795 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 1 DF, (AMPOULE) | Y | S0003B,S0004,S0003,S0004B,S0003E,S0 | 103976 | 2 | DF | SOLUTION FOR INJECTION | |||||
| 981979515 | 9819795 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 2 AMPOULES PER MONTH | Y | S0003B,S0004,S0003,S0004B,S0003E,S0 | 103976 | 150 | MG | SOLUTION FOR INJECTION | |||||
| 981979515 | 9819795 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, QMO | Y | S0003B,S0004,S0003,S0004B,S0003E,S0 | 103976 | 300 | MG | SOLUTION FOR INJECTION | /month | ||||
| 981979515 | 9819795 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | Y | S0003B,S0004,S0003,S0004B,S0003E,S0 | 103976 | SOLUTION FOR INJECTION | |||||||
| 981979515 | 9819795 | 12 | SS | HYDROCORTISONE. | HYDROCORTISONE | 1 | Unknown | UNK | U | 0 | |||||||||
| 981979515 | 9819795 | 13 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | 1 DF, UNK | U | 302084A | 0 | 1 | DF | ||||||
| 981979515 | 9819795 | 14 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | 1 DF, QD (JET) | U | 302084A | 0 | 1 | DF | QD | |||||
| 981979515 | 9819795 | 15 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 2.5 UG, BID (1 ASPIRATION) | U | 302084A | 0 | 2.5 | UG | BID | |||||
| 981979515 | 9819795 | 16 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | UNK, BID | U | 302084A | 0 | BID | |||||||
| 981979515 | 9819795 | 17 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Oral | UNK | U | 302084A | 0 | ||||||||
| 981979515 | 9819795 | 18 | C | SERETIDE | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | 2 DF, QD (JET) | 32O0631 | 0 | 2 | DF | QD | ||||||
| 981979515 | 9819795 | 19 | C | MONTELAIR | MONTELUKAST SODIUM | 1 | Oral | 1 DF, QD | U | 0 | 10 | MG | TABLET | QD | |||||
| 981979515 | 9819795 | 20 | C | MONTELAIR | MONTELUKAST SODIUM | 1 | Oral | 200 MG, BID | U | 0 | 200 | MG | TABLET | BID | |||||
| 981979515 | 9819795 | 21 | C | MONTELAIR | MONTELUKAST SODIUM | 1 | Oral | 25 MG, QD | U | 0 | 25 | MG | TABLET | QD | |||||
| 981979515 | 9819795 | 22 | C | SERETIDE | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Respiratory (inhalation) | 1 DF (50/250 MG), QD (JET) | 32O0631 | 0 | 1 | DF | TABLET | QD | |||||
| 981979515 | 9819795 | 23 | C | SERETIDE | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | 50/500, 2 PUFFS, (1 PUFF IN THE MORNING/ 1 PUFF AT NIGHT) | 32O0631 | 0 | 2 | DF | TABLET | QD | |||||
| 981979515 | 9819795 | 24 | C | SERETIDE | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Oral | UNK, BID | 32O0631 | 0 | TABLET | BID | |||||||
| 981979515 | 9819795 | 25 | C | BEROTEC | FENOTEROL HYDROBROMIDE | 1 | Unknown | 3 DF, QD (JET) | 0 | 3 | DF | TABLET | QD | ||||||
| 981979515 | 9819795 | 26 | C | ATROVENT | IPRATROPIUM BROMIDE | 1 | Unknown | 7 DRP, QD | 0 | 7 | GTT | TABLET | QD | ||||||
| 981979515 | 9819795 | 27 | C | TIOTROPIUM BROMIDE | TIOTROPIUM BROMIDE | 1 | Respiratory (inhalation) | 1 DF, QD | 0 | 1 | DF | QD | |||||||
| 981979515 | 9819795 | 28 | C | TIOTROPIUM BROMIDE | TIOTROPIUM BROMIDE | 1 | Respiratory (inhalation) | 0 | 1 | DF | QD | ||||||||
| 981979515 | 9819795 | 29 | C | TEOLONG | 2 | Oral | 1 DF, BID | 0 | 1 | DF | TABLET | BID | |||||||
| 981979515 | 9819795 | 30 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | U | 0 | TABLET | |||||||||
| 981979515 | 9819795 | 31 | C | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Unknown | 500 MG, QW | U | 0 | 500 | MG | TABLET | /wk | |||||
| 981979515 | 9819795 | 32 | C | AMINOPHYLLINE. | AMINOPHYLLINE | 1 | Unknown | UNK, QW | U | 0 | TABLET | /wk | |||||||
| 981979515 | 9819795 | 33 | C | RELVAR | FLUTICASONE FUROATEVILANTEROL TRIFENATATE | 1 | Respiratory (inhalation) | 200/250 MCG, 1 ASPIRATION | U | 0 | 1 | DF | TABLET | BID | |||||
| 981979515 | 9819795 | 34 | C | RELVAR | FLUTICASONE FUROATEVILANTEROL TRIFENATATE | 1 | Oral | 250 MG, QD | U | 0 | 250 | MG | TABLET | QD | |||||
| 981979515 | 9819795 | 35 | C | RELVAR | FLUTICASONE FUROATEVILANTEROL TRIFENATATE | 1 | Respiratory (inhalation) | BID RESPIRATORY INHALATION | U | 0 | TABLET | BID | |||||||
| 981979515 | 9819795 | 36 | C | FORASEQ (BRAZIL) | BUDESONIDEFORMOTEROL FUMARATE | 1 | Respiratory (inhalation) | 12/400 MCG, 1 ASPIRATION | 0 | 1 | DF | TABLET | QD | ||||||
| 981979515 | 9819795 | 37 | C | FLIXOTIDE | FLUTICASONE PROPIONATE | 1 | Respiratory (inhalation) | 1 DF (250 UG), QD (1 ASPIRATION) | U | 0 | 1 | DF | TABLET | QD | |||||
| 981979515 | 9819795 | 38 | C | FLIXOTIDE | FLUTICASONE PROPIONATE | 1 | Oral | UNK, BID | U | 0 | TABLET | BID | |||||||
| 981979515 | 9819795 | 39 | C | DIOVAN | VALSARTAN | 1 | Oral | 25 MG, QD | U | 0 | 25 | MG | TABLET | QD | |||||
| 981979515 | 9819795 | 40 | C | PREDSIN | 2 | Oral | 20 MG, QD (FOR 2 MONTHS) | U | 0 | 20 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 981979515 | 9819795 | 1 | Asthma |
| 981979515 | 9819795 | 12 | Product used for unknown indication |
| 981979515 | 9819795 | 13 | Asthma |
| 981979515 | 9819795 | 18 | Asthma |
| 981979515 | 9819795 | 19 | Asthma |
| 981979515 | 9819795 | 22 | Asthma |
| 981979515 | 9819795 | 25 | Asthma |
| 981979515 | 9819795 | 26 | Asthma |
| 981979515 | 9819795 | 27 | Asthma |
| 981979515 | 9819795 | 29 | Asthma |
| 981979515 | 9819795 | 30 | Product used for unknown indication |
| 981979515 | 9819795 | 31 | Product used for unknown indication |
| 981979515 | 9819795 | 32 | Product used for unknown indication |
| 981979515 | 9819795 | 33 | Asthma |
| 981979515 | 9819795 | 36 | Asthma |
| 981979515 | 9819795 | 37 | Asthma |
| 981979515 | 9819795 | 39 | Asthma |
| 981979515 | 9819795 | 40 | Asthma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 981979515 | 9819795 | HO |
| 981979515 | 9819795 | LT |
| 981979515 | 9819795 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 981979515 | 9819795 | Anaemia | |
| 981979515 | 9819795 | Aphonia | |
| 981979515 | 9819795 | Application site bruise | |
| 981979515 | 9819795 | Asthenia | |
| 981979515 | 9819795 | Asthma | Asthma |
| 981979515 | 9819795 | Blister | |
| 981979515 | 9819795 | Blood immunoglobulin E increased | |
| 981979515 | 9819795 | Blood pressure increased | |
| 981979515 | 9819795 | Cardiac arrest | |
| 981979515 | 9819795 | Cerebrovascular accident | |
| 981979515 | 9819795 | Chronic sinusitis | |
| 981979515 | 9819795 | Dental caries | |
| 981979515 | 9819795 | Drug administration error | |
| 981979515 | 9819795 | Drug ineffective | |
| 981979515 | 9819795 | Dry mouth | |
| 981979515 | 9819795 | Fatigue | |
| 981979515 | 9819795 | Feeling abnormal | |
| 981979515 | 9819795 | Generalised erythema | |
| 981979515 | 9819795 | Haematemesis | |
| 981979515 | 9819795 | Haemorrhage | |
| 981979515 | 9819795 | Heart rate increased | |
| 981979515 | 9819795 | Hypotension | |
| 981979515 | 9819795 | Injection site discomfort | |
| 981979515 | 9819795 | Injection site erythema | |
| 981979515 | 9819795 | Injection site pain | |
| 981979515 | 9819795 | Lung disorder | |
| 981979515 | 9819795 | Malaise | |
| 981979515 | 9819795 | Menorrhagia | |
| 981979515 | 9819795 | Pharyngeal oedema | |
| 981979515 | 9819795 | Pneumonia | |
| 981979515 | 9819795 | Post procedural complication | |
| 981979515 | 9819795 | Post procedural haemorrhage | |
| 981979515 | 9819795 | Speech disorder | |
| 981979515 | 9819795 | Tracheal disorder | |
| 981979515 | 9819795 | Visual acuity reduced | |
| 981979515 | 9819795 | Vomiting | |
| 981979515 | 9819795 | 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 |
|---|---|---|---|---|---|---|
| 981979515 | 9819795 | 1 | 2004 | 0 | ||
| 981979515 | 9819795 | 2 | 200507 | 0 | ||
| 981979515 | 9819795 | 4 | 2009 | 2009 | 0 | |
| 981979515 | 9819795 | 5 | 20140930 | 0 | ||
| 981979515 | 9819795 | 6 | 2010 | 2010 | 0 | |
| 981979515 | 9819795 | 7 | 20130613 | 0 | ||
| 981979515 | 9819795 | 8 | 20140930 | 0 | ||
| 981979515 | 9819795 | 9 | 2006 | 2011 | 0 | |
| 981979515 | 9819795 | 11 | 201604 | 0 | ||
| 981979515 | 9819795 | 13 | 20140713 | 20140713 | 0 | |
| 981979515 | 9819795 | 14 | 201408 | 0 | ||
| 981979515 | 9819795 | 18 | 201408 | 0 | ||
| 981979515 | 9819795 | 19 | 201408 | 0 | ||
| 981979515 | 9819795 | 22 | 201408 | 0 | ||
| 981979515 | 9819795 | 25 | 2004 | 0 | ||
| 981979515 | 9819795 | 26 | 2004 | 0 | ||
| 981979515 | 9819795 | 33 | 201502 | 0 | ||
| 981979515 | 9819795 | 37 | 201601 | 0 |