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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125321321 | 12532132 | 1 | I | 20151028 | 20160608 | 20160706 | 20160706 | EXP | GB-SAOL THERAPEUTICS-2016SAO00109 | SAOL THERAPEUTICS | 51.78 | YR | F | Y | 0.00000 | 20160706 | CN | COUNTRY NOT SPECIFIED | GB |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125321321 | 12532132 | 1 | PS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 57.5 ?G, DAY | 646 | UG | 20075 | 57.5 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 2 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 66.19 ?G, DAY | 646 | UG | 20075 | 66.19 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 3 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 76.18 ?G, DAY | 646 | UG | 20075 | 76.18 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 4 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 100.8 ?G, DAY | 646 | UG | 20075 | 100.8 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 5 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 115.88 ?G, DAY | 646 | UG | 20075 | 115.88 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 6 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 133.14 ?G, DAY | 646 | UG | 20075 | 133.14 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 7 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 176.68 ?G, DAY | 646 | UG | 20075 | 176.68 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 8 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 203.36 ?G, DAY | 646 | UG | 20075 | 203.36 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 9 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 233.5 ?G, DAY | 646 | UG | 20075 | 233.5 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 10 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 267.82 ?G, DAY | 646 | UG | 20075 | 267.82 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 11 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 306.71 ?G, DAY | 646 | UG | 20075 | 306.71 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 12 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 353.36 ?G, DAY | 646 | UG | 20075 | 353.36 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 13 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 465.8 ?G, DAY | 646 | UG | 20075 | 465.8 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 14 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 535.6 ?G, DAY | 646 | UG | 20075 | 535.6 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 15 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 615.5 ?G, DAY | 646 | UG | 20075 | 615.5 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 16 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 87.67 ?G, DAY | 646 | UG | 20075 | 87.67 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 17 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 153.36 ?G, DAY | 646 | UG | 20075 | 153.36 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 18 | SS | LIORESAL | BACLOFEN | 1 | Intravenous (not otherwise specified) | 404.94 ?G, DAY | 646 | UG | 20075 | 404.94 | UG | INJECTION | QD | ||||
125321321 | 12532132 | 19 | C | BACLOFEN. | BACLOFEN | 1 | Oral | UNK | 260 | MG | U | 0 | ORAL SUSPENSION | ||||||
125321321 | 12532132 | 20 | C | BACLOFEN. | BACLOFEN | 1 | Oral | 30 MG, 3X/DAY | 260 | MG | U | 0 | 30 | MG | ORAL SUSPENSION | TID | |||
125321321 | 12532132 | 21 | C | BACLOFEN. | BACLOFEN | 1 | Oral | UNK | 260 | MG | U | 0 | ORAL SUSPENSION | ||||||
125321321 | 12532132 | 22 | C | BACLOFEN. | BACLOFEN | 1 | UNK | 260 | MG | U | 0 | ORAL SUSPENSION | |||||||
125321321 | 12532132 | 23 | C | BACLOFEN. | BACLOFEN | 1 | Oral | UNK | 260 | MG | U | 0 | ORAL SUSPENSION | ||||||
125321321 | 12532132 | 24 | C | BACLOFEN. | BACLOFEN | 1 | Oral | 10 MG, 2X/DAY | 260 | MG | U | 0 | 10 | MG | ORAL SUSPENSION | BID | |||
125321321 | 12532132 | 25 | C | BACLOFEN. | BACLOFEN | 1 | 10 MG, 1X/DAY | 260 | MG | U | 0 | 10 | MG | ORAL SUSPENSION | QD | ||||
125321321 | 12532132 | 26 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 75 MG, DAY | 0 | 75 | MG | QD | |||||||
125321321 | 12532132 | 27 | C | SENNA | SENNA LEAFSENNOSIDESSENNOSIDES A AND B | 1 | Oral | 7.5 MG, AS NEEDED | 0 | 7.5 | MG | ||||||||
125321321 | 12532132 | 28 | C | TOLTERODINE | TOLTERODINE | 1 | Oral | 2 MG, 2X/DAY | 0 | 2 | MG | BID | |||||||
125321321 | 12532132 | 29 | C | SALBUTAMOL | ALBUTEROL | 1 | Respiratory (inhalation) | 100 ?G, AS NEEDED | 0 | 100 | UG | ||||||||
125321321 | 12532132 | 30 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | Respiratory (inhalation) | 500 ?G, 2X/DAY | 0 | 500 | UG | BID | |||||||
125321321 | 12532132 | 31 | C | SALMETEROL | SALMETEROL | 1 | Respiratory (inhalation) | 50 ?G, 2X/DAY | 0 | 50 | UG | BID | |||||||
125321321 | 12532132 | 32 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 40 MG, 1X/DAY | 0 | 40 | MG | QD | |||||||
125321321 | 12532132 | 33 | C | TIZANIDINE. | TIZANIDINE | 1 | Oral | 12 MG, 3X/DAY | 50328 | MG | 0 | 12 | MG | TID | |||||
125321321 | 12532132 | 34 | C | TIZANIDINE. | TIZANIDINE | 1 | Oral | UNK | 50328 | MG | 0 | ||||||||
125321321 | 12532132 | 35 | C | TIZANIDINE. | TIZANIDINE | 1 | Oral | UNK | 50328 | MG | 0 | ||||||||
125321321 | 12532132 | 36 | C | TIZANIDINE. | TIZANIDINE | 1 | Oral | 8 UNK, UNK | 50328 | MG | 0 | 8 | MG | TID | |||||
125321321 | 12532132 | 37 | C | TIZANIDINE. | TIZANIDINE | 1 | Oral | UNK | 50328 | MG | 0 | ||||||||
125321321 | 12532132 | 38 | C | TIZANIDINE. | TIZANIDINE | 1 | Oral | UNK | 50328 | MG | 0 | ||||||||
125321321 | 12532132 | 39 | C | TIZANIDINE. | TIZANIDINE | 1 | Oral | UNK | 50328 | MG | 0 | ||||||||
125321321 | 12532132 | 40 | C | LIDOCAINE. | LIDOCAINE | 1 | UNK | 0 | |||||||||||
125321321 | 12532132 | 41 | C | IBUPROFEN. | IBUPROFEN | 1 | Oral | 200 MG, AS NEEDED | 0 | 200 | MG | ||||||||
125321321 | 12532132 | 42 | C | CITALOPRAM HYDROCHLORIDE | CITALOPRAM HYDROCHLORIDE | 1 | Oral | 40 MG, 1X/DAY | 22400 | MG | 0 | 40 | MG | QD | |||||
125321321 | 12532132 | 43 | C | CITALOPRAM HYDROCHLORIDE | CITALOPRAM HYDROCHLORIDE | 1 | Oral | 20 MG, 1X/DAY | 22400 | MG | 0 | 20 | MG | QD | |||||
125321321 | 12532132 | 44 | C | VITAMIN-B | 2 | Oral | 1 TABLETS, DAY | 0 | 1 | DF | QD | ||||||||
125321321 | 12532132 | 45 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 1000 ?G, 4X/DAY | 0 | 1000 | UG | QID | |||||||
125321321 | 12532132 | 46 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | UNK | 0 | ||||||||||
125321321 | 12532132 | 47 | C | MORPHINE SULFATE. | MORPHINE SULFATE | 1 | Oral | 10 MG, AS NEEDED | 0 | 10 | MG |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125321321 | 12532132 | 1 | Muscle spasticity |
125321321 | 12532132 | 19 | Muscle spasticity |
125321321 | 12532132 | 26 | Cerebrovascular accident |
125321321 | 12532132 | 27 | Constipation |
125321321 | 12532132 | 28 | Urinary incontinence |
125321321 | 12532132 | 29 | Asthma |
125321321 | 12532132 | 30 | Asthma |
125321321 | 12532132 | 31 | Asthma |
125321321 | 12532132 | 32 | Hyperlipidaemia |
125321321 | 12532132 | 33 | Muscle spasticity |
125321321 | 12532132 | 40 | Analgesic therapy |
125321321 | 12532132 | 41 | Analgesic therapy |
125321321 | 12532132 | 42 | Depressed mood |
125321321 | 12532132 | 45 | Analgesic therapy |
125321321 | 12532132 | 47 | Analgesic therapy |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125321321 | 12532132 | Productive cough | |
125321321 | 12532132 | Upper respiratory tract infection | |
125321321 | 12532132 | 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 |
---|---|---|---|---|---|---|
125321321 | 12532132 | 1 | 20150616 | 20150616 | 0 | |
125321321 | 12532132 | 2 | 20150619 | 20150619 | 0 | |
125321321 | 12532132 | 3 | 20150623 | 20150623 | 0 | |
125321321 | 12532132 | 4 | 20150630 | 20150630 | 0 | |
125321321 | 12532132 | 5 | 20150703 | 20150703 | 0 | |
125321321 | 12532132 | 6 | 20150706 | 20150706 | 0 | |
125321321 | 12532132 | 7 | 20150708 | 20150708 | 0 | |
125321321 | 12532132 | 8 | 20150710 | 20150710 | 0 | |
125321321 | 12532132 | 9 | 20150713 | 20150713 | 0 | |
125321321 | 12532132 | 10 | 20150714 | 20150714 | 0 | |
125321321 | 12532132 | 11 | 20150715 | 20150715 | 0 | |
125321321 | 12532132 | 12 | 20150717 | 20150717 | 0 | |
125321321 | 12532132 | 13 | 20150721 | 20150721 | 0 | |
125321321 | 12532132 | 14 | 20150722 | 20150722 | 0 | |
125321321 | 12532132 | 15 | 20150723 | 20150723 | 0 | |
125321321 | 12532132 | 16 | 20150626 | 20150626 | 0 | |
125321321 | 12532132 | 17 | 20150707 | 20150707 | 0 | |
125321321 | 12532132 | 18 | 20150720 | 20150720 | 0 | |
125321321 | 12532132 | 19 | 20110617 | 20150713 | 0 | |
125321321 | 12532132 | 20 | 20150713 | 20150714 | 0 | |
125321321 | 12532132 | 21 | 20150714 | 20150715 | 0 | |
125321321 | 12532132 | 22 | 20150715 | 20150717 | 0 | |
125321321 | 12532132 | 23 | 20150717 | 20150720 | 0 | |
125321321 | 12532132 | 24 | 20150720 | 20150722 | 0 | |
125321321 | 12532132 | 25 | 20150722 | 20150723 | 0 | |
125321321 | 12532132 | 26 | 20150607 | 0 | ||
125321321 | 12532132 | 27 | 20110818 | 0 | ||
125321321 | 12532132 | 28 | 20110611 | 0 | ||
125321321 | 12532132 | 29 | 20110719 | 0 | ||
125321321 | 12532132 | 30 | 20110719 | 0 | ||
125321321 | 12532132 | 31 | 20110719 | 0 | ||
125321321 | 12532132 | 32 | 20090528 | 0 | ||
125321321 | 12532132 | 33 | 20110917 | 20150713 | 0 | |
125321321 | 12532132 | 34 | 20150713 | 20150714 | 0 | |
125321321 | 12532132 | 35 | 20110714 | 20150715 | 0 | |
125321321 | 12532132 | 36 | 20150715 | 20150717 | 0 | |
125321321 | 12532132 | 37 | 20150717 | 20150720 | 0 | |
125321321 | 12532132 | 38 | 20150720 | 20150722 | 0 | |
125321321 | 12532132 | 39 | 20150722 | 20150723 | 0 | |
125321321 | 12532132 | 40 | 20150616 | 20150619 | 0 | |
125321321 | 12532132 | 41 | 20150615 | 20150616 | 0 | |
125321321 | 12532132 | 42 | 20140225 | 20150907 | 0 | |
125321321 | 12532132 | 43 | 20150908 | 0 | ||
125321321 | 12532132 | 44 | 20110719 | 0 | ||
125321321 | 12532132 | 45 | 20110719 | 0 | ||
125321321 | 12532132 | 46 | 20110719 | 0 | ||
125321321 | 12532132 | 47 | 20150614 | 20150615 | 0 |