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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117765683 | 11776568 | 3 | F | 20160212 | 20160921 | 20151125 | 20160923 | PER | PHEH2015US024491 | NOVARTIS | 73.42 | YR | F | Y | 58.50000 | KG | 20160923 | CN | COUNTRY NOT SPECIFIED | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117765683 | 11776568 | 1 | PS | PROMACTA | ELTROMBOPAG OLAMINE | 1 | Oral | 50 MG, UNK | D | 22291 | 50 | MG | TABLET | ||||||
| 117765683 | 11776568 | 2 | SS | PROMACTA | ELTROMBOPAG OLAMINE | 1 | D | 22291 | TABLET | ||||||||||
| 117765683 | 11776568 | 3 | C | NACL | SODIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 1000 ML, UNK | D | 0 | 1000 | ML | |||||||
| 117765683 | 11776568 | 4 | C | KCL | POTASSIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 1000 ML, UNK | D | 0 | 1000 | ML | |||||||
| 117765683 | 11776568 | 5 | C | ALBUTEROL. | ALBUTEROL | 1 | Respiratory (inhalation) | 1.25 MG/3ML, Q4H PRN | D | 0 | 1.25 | MG | INHALATION SOLUTION | Q4H | |||||
| 117765683 | 11776568 | 6 | C | ALBUTEROL. | ALBUTEROL | 1 | Respiratory (inhalation) | 2 DF, PRN QID | D | 0 | 2 | DF | INHALATION SOLUTION | ||||||
| 117765683 | 11776568 | 7 | C | ATIVAN | LORAZEPAM | 1 | Oral | 1 DF, Q4H PRN | D | 0 | 1 | DF | TABLET | Q4H | |||||
| 117765683 | 11776568 | 8 | C | BENTYL | DICYCLOMINE HYDROCHLORIDE | 1 | Oral | 10 MG, TID PRN | D | 0 | 10 | MG | CAPSULE | TID | |||||
| 117765683 | 11776568 | 9 | C | BETAPACE | SOTALOL HYDROCHLORIDE | 1 | Oral | 1 DF, BID | D | 0 | 1 | DF | TABLET | BID | |||||
| 117765683 | 11776568 | 10 | C | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Oral | 1 DF, Q8H | D | 0 | 1 | DF | TABLET | Q8H | |||||
| 117765683 | 11776568 | 11 | C | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 3 ML, Q8H | D | 0 | 3 | ML | TABLET | Q8H | |||||
| 117765683 | 11776568 | 12 | C | TYLENOL | ACETAMINOPHEN | 1 | Oral | 2 DF, Q4H PRN | D | 0 | 2 | DF | TABLET | Q4H | |||||
| 117765683 | 11776568 | 13 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 2 ML, Q4H PRN | D | 0 | 1 | DF | INJECTION | Q4H | |||||
| 117765683 | 11776568 | 14 | C | BENICAR | OLMESARTAN MEDOXOMIL | 1 | Oral | 40 MG, QD | D | 0 | 40 | MG | TABLET | QD | |||||
| 117765683 | 11776568 | 15 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Oral | 1 DF, QHS | D | 0 | 1 | DF | TABLET | ||||||
| 117765683 | 11776568 | 16 | C | SOTALOL. | SOTALOL | 1 | Oral | 1 DF, BID | D | 0 | 1 | DF | TABLET | BID | |||||
| 117765683 | 11776568 | 17 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 2 DF, BID | D | 0 | 2 | DF | AEROSOL | BID | |||||
| 117765683 | 11776568 | 18 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 2 DF, QD | D | 0 | 2 | DF | TABLET | QD | |||||
| 117765683 | 11776568 | 19 | C | LEVAQUIN | LEVOFLOXACIN | 1 | Unknown | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117765683 | 11776568 | 1 | Immune thrombocytopenic purpura |
| 117765683 | 11776568 | 2 | Myelodysplastic syndrome |
| 117765683 | 11776568 | 3 | Product used for unknown indication |
| 117765683 | 11776568 | 4 | Product used for unknown indication |
| 117765683 | 11776568 | 5 | Product used for unknown indication |
| 117765683 | 11776568 | 7 | Product used for unknown indication |
| 117765683 | 11776568 | 8 | Product used for unknown indication |
| 117765683 | 11776568 | 9 | Product used for unknown indication |
| 117765683 | 11776568 | 10 | Product used for unknown indication |
| 117765683 | 11776568 | 12 | Product used for unknown indication |
| 117765683 | 11776568 | 13 | Product used for unknown indication |
| 117765683 | 11776568 | 14 | Product used for unknown indication |
| 117765683 | 11776568 | 15 | Product used for unknown indication |
| 117765683 | 11776568 | 16 | Product used for unknown indication |
| 117765683 | 11776568 | 17 | Product used for unknown indication |
| 117765683 | 11776568 | 18 | Product used for unknown indication |
| 117765683 | 11776568 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117765683 | 11776568 | HO |
| 117765683 | 11776568 | DE |
| 117765683 | 11776568 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117765683 | 11776568 | Abdominal distension | |
| 117765683 | 11776568 | Abdominal pain | |
| 117765683 | 11776568 | Abdominal pain lower | |
| 117765683 | 11776568 | Bronchospasm | |
| 117765683 | 11776568 | Chronic obstructive pulmonary disease | |
| 117765683 | 11776568 | Colitis | |
| 117765683 | 11776568 | Coronary artery disease | |
| 117765683 | 11776568 | Death | |
| 117765683 | 11776568 | Diarrhoea | |
| 117765683 | 11776568 | Diverticulitis | |
| 117765683 | 11776568 | Dyspnoea | |
| 117765683 | 11776568 | Epigastric discomfort | |
| 117765683 | 11776568 | Fatigue | |
| 117765683 | 11776568 | Feeding disorder | |
| 117765683 | 11776568 | Feeling abnormal | |
| 117765683 | 11776568 | Gastritis | |
| 117765683 | 11776568 | Gastroenteritis | |
| 117765683 | 11776568 | Haemoglobin decreased | |
| 117765683 | 11776568 | Hyperkalaemia | |
| 117765683 | 11776568 | Myocardial infarction | |
| 117765683 | 11776568 | Nausea | |
| 117765683 | 11776568 | Therapy non-responder |
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 |
|---|---|---|---|---|---|---|
| 117765683 | 11776568 | 1 | 20151013 | 20151210 | 0 |