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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125053773 | 12505377 | 3 | F | 20150827 | 20160816 | 20160628 | 20160825 | EXP | PHEH2016US015573 | NOVARTIS | 82.11 | YR | F | Y | 55.45000 | KG | 20160825 | CN | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125053773 | 12505377 | 1 | PS | GLEEVEC | IMATINIB MESYLATE | 1 | Oral | 400 MG, QD | Y | 21588 | 400 | MG | TABLET | QD | |||||
| 125053773 | 12505377 | 2 | SS | SUTENT | SUNITINIB MALATE | 1 | Oral | 50 MG, QD | Y | 0 | 50 | MG | CAPSULE | QD | |||||
| 125053773 | 12505377 | 3 | SS | SUTENT | SUNITINIB MALATE | 1 | Oral | 50 MG, QD | Y | 0 | 50 | MG | CAPSULE | QD | |||||
| 125053773 | 12505377 | 4 | C | IRON | IRON | 1 | Oral | 325 MG, BID | U | 0 | 325 | MG | BID | ||||||
| 125053773 | 12505377 | 5 | C | LASIX | FUROSEMIDE | 1 | Oral | 20 MG, QD | U | 0 | 20 | MG | QD | ||||||
| 125053773 | 12505377 | 6 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | Oral | 17 G, QD, 17 G/DOSEMIXED WITH 8 OZ WATER, JUICE, SODA, ETC | U | 0 | 17 | G | QD | ||||||
| 125053773 | 12505377 | 7 | C | NYSTATIN. | NYSTATIN | 1 | Oral | 5 ML, QID (100000UNIT/ML) | U | 0 | 5 | ML | ORAL SUSPENSION | QID | |||||
| 125053773 | 12505377 | 8 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 40 MG, QD, BEFORE MEAL | U | 0 | 40 | MG | CAPSULE | QD | |||||
| 125053773 | 12505377 | 9 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 4 MG, PRN | U | 0 | 4 | MG | |||||||
| 125053773 | 12505377 | 10 | C | PHENERGAN | PROMETHAZINE HYDROCHLORIDE | 1 | Oral | 25 MG, PRN | U | 0 | 25 | MG | |||||||
| 125053773 | 12505377 | 11 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Unknown | U | 0 | ||||||||||
| 125053773 | 12505377 | 12 | C | METRONIDAZOL//METRONIDAZOLE | 2 | Unknown | U | 0 | |||||||||||
| 125053773 | 12505377 | 13 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 2 DF, Q6H, AS NEEDED | U | 0 | 2 | DF | TABLET | Q6H | |||||
| 125053773 | 12505377 | 14 | C | ONDANSETRON | ONDANSETRON | 1 | Oral | 4 MG, Q8H | U | 0 | 4 | MG | TABLET | Q8H | |||||
| 125053773 | 12505377 | 15 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | Oral | 100 MG, BID, AT BEDTIME, AS NEEDED | U | 0 | 100 | MG | CAPSULE | BID | |||||
| 125053773 | 12505377 | 16 | C | MELATONIN | MELATONIN | 1 | Unknown | 3 MG, UNK | U | 0 | 3 | MG | TABLET | ||||||
| 125053773 | 12505377 | 17 | C | THERA-M | 2 | Unknown | U | 0 | TABLET | ||||||||||
| 125053773 | 12505377 | 18 | C | ACIDOPHILUS /08551901/ | MINERALSPROBIOTICS NOSVITAMINS | 1 | Unknown | U | 0 | CAPSULE | |||||||||
| 125053773 | 12505377 | 19 | C | PEPCID | FAMOTIDINE | 1 | Oral | 20 MG, BID | Y | 0 | 20 | MG | TABLET | BID | |||||
| 125053773 | 12505377 | 20 | C | VITAMIN C | ASCORBIC ACID | 1 | Unknown | 500 MG, UNK | Y | 0 | 500 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125053773 | 12505377 | 1 | Gastrointestinal stromal tumour |
| 125053773 | 12505377 | 2 | Gastrointestinal stromal tumour |
| 125053773 | 12505377 | 4 | Product used for unknown indication |
| 125053773 | 12505377 | 5 | Product used for unknown indication |
| 125053773 | 12505377 | 6 | Product used for unknown indication |
| 125053773 | 12505377 | 7 | Product used for unknown indication |
| 125053773 | 12505377 | 8 | Product used for unknown indication |
| 125053773 | 12505377 | 9 | Product used for unknown indication |
| 125053773 | 12505377 | 10 | Product used for unknown indication |
| 125053773 | 12505377 | 11 | Product used for unknown indication |
| 125053773 | 12505377 | 12 | Product used for unknown indication |
| 125053773 | 12505377 | 13 | Product used for unknown indication |
| 125053773 | 12505377 | 14 | Nausea |
| 125053773 | 12505377 | 15 | Product used for unknown indication |
| 125053773 | 12505377 | 16 | Product used for unknown indication |
| 125053773 | 12505377 | 17 | Product used for unknown indication |
| 125053773 | 12505377 | 18 | Product used for unknown indication |
| 125053773 | 12505377 | 19 | Product used for unknown indication |
| 125053773 | 12505377 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125053773 | 12505377 | HO |
| 125053773 | 12505377 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125053773 | 12505377 | Abdominal distension | |
| 125053773 | 12505377 | Abdominal mass | |
| 125053773 | 12505377 | Abdominal pain | |
| 125053773 | 12505377 | Appendix disorder | |
| 125053773 | 12505377 | Ascites | |
| 125053773 | 12505377 | Asthenia | |
| 125053773 | 12505377 | Cellulitis | |
| 125053773 | 12505377 | Drug ineffective | |
| 125053773 | 12505377 | Fatigue | |
| 125053773 | 12505377 | Flushing | |
| 125053773 | 12505377 | Gastrointestinal perforation | |
| 125053773 | 12505377 | Gastrointestinal stromal tumour | |
| 125053773 | 12505377 | Gastrointestinal wall thickening | |
| 125053773 | 12505377 | Gastrooesophageal reflux disease | |
| 125053773 | 12505377 | Hepatic lesion | |
| 125053773 | 12505377 | Hyponatraemia | |
| 125053773 | 12505377 | Intestinal perforation | |
| 125053773 | 12505377 | Iron deficiency anaemia | |
| 125053773 | 12505377 | Leukopenia | |
| 125053773 | 12505377 | Lymphadenopathy | |
| 125053773 | 12505377 | Malignant neoplasm progression | |
| 125053773 | 12505377 | Metastases to abdominal cavity | |
| 125053773 | 12505377 | Metastases to liver | |
| 125053773 | 12505377 | Oedema | |
| 125053773 | 12505377 | Oedema peripheral | |
| 125053773 | 12505377 | Pelvic abscess | |
| 125053773 | 12505377 | Peritonitis | |
| 125053773 | 12505377 | Pneumoperitoneum | |
| 125053773 | 12505377 | Tenderness | |
| 125053773 | 12505377 | Thrombocytopenia | |
| 125053773 | 12505377 | Urinary tract infection | |
| 125053773 | 12505377 | Vision blurred | |
| 125053773 | 12505377 | Visual acuity tests abnormal | |
| 125053773 | 12505377 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125053773 | 12505377 | 1 | 201508 | 20160427 | 0 | |
| 125053773 | 12505377 | 2 | 20160501 | 20160510 | 0 | |
| 125053773 | 12505377 | 3 | 20160519 | 20160609 | 0 |