Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
...(72%/71%),dysphagia (65%/63%), asthenia (56%/49%), nausea (49%/37%),constipation (35%/30%) and vomiting (29%...%), asthenia/malaise(73%/48%), diarrhea (72%/25%), nausea (55%/29%), abdominal pain(45%/26%), vomiting (41%/25%), fever (34%/27%), constipation(30%/26%), and ......placebo arm were rash (20 percent vs. 10 percent), nausea (14percent vs. 12 percent), diarrhea (12 percent v.... 9 percent), diarrhea (18 percentvs. 20 percent), nausea (14 percent vs. 10 percent), injection sitereaction (13 percent vs. 15 percent), headache (9 percent...... regardless of severity werediarrhea (32 percent), nausea (18 percent), nasopharyngitis (12percent), headach...eported adverse events were diarrhea (42 percent), nausea (21percent) and nasopharyngitis (11 percent). Grade 2-4 diarrheaoccurred in 8 percent of patients ta...... 49% (Grade 3/4: 8%); alopecia 48% (Grade3/4: 0%); nausea 42% (Grade 3/4: 2%); stomatitis/mucositis 29%(Grade 3/4: 7%); vomiting 29% (Grade 3/4: 1%); diarrhea 22% (Grade3/4: 1%); and musculoskeletal pain 20% (Grade 3/4: 3%).Treatment-related hematological adverse events greater than orequal to 20% included:......4.6%), headache (cethromycin 3.1%,Biaxin(R) 6.5%), nausea (cethromycin 2.7%, Biaxin(R) 3.8%),vomiting (cethromycin 2.7%, Biaxin(R) 1.5%), abdominal pain(cethromycin 1.5%, Biaxin(R) 3.1%) and taste disturbance(cethromycin 11.1%, Biaxin(R) 6.2%). No drug-related seriousadverse events were observed in any stud......rted adverse eventswere asthenic conditions (64%), nausea (55%) in single-agentVELCADE, diarrhea (52%), constipation (41%), peripheral neuropathy(39%), thrombocytopenia (36%), appetite decrease, including reportsof anorexia (36%), pyrexia (34%), vomiting (33%) and anemia (29%).Twenty percent of patients rep......rted adverse eventswere asthenic conditions (64%), nausea (55%) in single-agentVELCADE, diarrhea (52%), constipation (41%), peripheral neuropathy(39%), thrombocytopenia (36%), appetite decrease, including reportsof anorexia (36%), pyrexia (34%), vomiting (33%) and anemia (29%).Twenty percent of patients rep......rted adverse eventswere asthenic conditions (64%), nausea (55%) in single-agentVELCADE, diarrhea (52%), constipation (41%), peripheral neuropathy(39%), thrombocytopenia (36%), appetite decrease, including reportsof anorexia (36%), pyrexia (34%), vomiting (33%) and anemia (29%).Twenty percent of patients rep......dominal pain (JANUVIA 100 mg, 2.3%; placebo,2.1%), nausea (1.4%, 0.6%), and diarrhea (3.0%, 2.3%). No clinically meaningful changes in vital signs or in ECG(including in QTc interval) were observed in patients treated withJANUVIA. Laboratory Tests The incidence of laboratory adverse reactions in pa......e, 2/6 onplacebo+metformin, 1/2 on placebo alone), nausea (n=5; 4/19 ondapagliflozin+metformin, 1/6 on placebo+metformin), and diarrhea(n=4; 3/19 on dapagliflozin+metformin, 1/6 onplacebo+metformin). Preclinical Data Also Presented at 2007 American DiabetesAssociation Annual Meeting In a second presentati...... diarrhea (9%versus 4%), gastritis (7% vs. 0%) and nausea (7% versus 2%). Nosubject had a treatment-related increase in liraglutideantibodies. About liraglutide Currently in phase 3 clinical trials, liraglutide is a humananalog of the naturally occurring hormone, Glucagon-Like Peptide-1(GLP-1), which is r......dominal pain (JANUVIA 100 mg, 2.3%; placebo,2.1%), nausea (1.4%, 0.6%), and diarrhea (3.0%, 2.3%). No clinically meaningful changes in vital signs or in ECG(including in QTc interval) were observed in patients treated withJANUVIA. Laboratory Tests The incidence of laboratory adverse reactions in pa...Liraglutide provides significantly better glucose control than insulin glargine in phase 3 study
...y reported adverse event in theliraglutide arm was nausea at an absolute level of between 10 and15%. As expected, the combination of a GLP-1 analogue with asulfonylurea leads to some of the patients experiencinghypoglycaemia. The overall hypoglycaemia event rate in theliraglutide and insulin glargine groups...Cethromycin Achieves Primary Endpoint in Pivotal Phase 3 Pneumonia Clinical Trial
...4.6%),headache (cethromycin 3.1%, Biaxin(R) 6.5%), nausea (cethromycin2.7%, Biaxin(R) 3.8%), vomiting (cethromycin 2.7%, Biaxin(R) 1.5%),abdominal pain (cethromycin 1.5%, Biaxin(R) 3.1%) and tastedisturbance (cethromycin 11.1%, Biaxin(R) 6.2%). No drug-relatedserious adverse events were observed in any stud......rted adverse eventswere asthenic conditions (64%), nausea (55%) in single-agentVELCADE, diarrhea (52%), constipation (41%), peripheral neuropathy(39%), thrombocytopenia (36%), appetite decrease, including reportsof anorexia (36%), pyrexia (34%), vomiting (33%) and anemia (29%).Twenty percent of patients rep...Salix Pharmaceuticals Announces Positive Top Line Results of Balsalazide Tablets Registration Study
... headache(8%); abdominal pain (6%); diarrhea (5%); nausea (5%); vomiting(4%); respiratory infection (4%); and arthralgia (4%). Withdrawalfrom therapy due to adverse events was comparable to placebo. Salix also markets XIFAXAN(R) (rifaximin) tablets 200 mg ,OSMOPREP(TM) Tablets (sodium phosphate monobasic m......fection, headache, abdominal pain, vomiting, and nausea occurred more frequently than in adults -- The kinds of infections reported were generally mild and similar to those usually seen in children -- Other serious adverse reactions were reported rarely, including serious infection (2%......d with the use of ZYFLO CR andZYFLO are sinusitis, nausea and pharyngolaryngeal pain andabdominal pain, upset stomach and nausea, respectively. For full prescribing information for ZYFLO CR, please visitwww.zyflocr.com or call the Company's toll free telephone number1-866-835-8216 to request medical inform......reupper respiratory tract infection (37 patients), nausea (36patients), and dizziness (31 patients). Most ad...ely reduce thedebilitating symptoms, such as pain, nausea and vomiting, nor themigraine's duration. For more information about MM, visit<a target="_blank"...NuPathe Reports Positive Phase One Results for NP101 Transdermal Therapy for Acute Migraine
...s who experience gastrointestinaldisorders such as nausea and vomiting during their migraineattack." According to Jane Hollingsworth, CEO of NuPathe, "Patients needbetter options for treatment of acute migraine attacks. Triptans,which are considered the gold standard in treatment today, areproven to be eff......morphine * Statistically significant reduction in nausea in the femalepatient population compared to morphi...phine but inducedsignificantly less post-operative nausea and vomiting (PONV). Sedation Analysis of the sedation data from the M6G022 trial showedstatistica...... thinking, seizures, chest pain, unexplained nausea or vomiting, or signs or symptoms of a stroke. You or your caregiver should seek immediate medical attention if these symptoms or other unusual symptoms occur. -- In order to prevent a possibly dangerous increase in blood pressure, ......drelief of migraine-associated symptoms, including nausea andsensitivity to light and sound, and improved functional disabilitytwo hours post dose, as well as reduced patients' need for rescuemedication. However, the study was not powered to evaluate astatistical response to these measures. In the study, t...Extensive Clinical Data on Erbitux Presented at the 2007 ASCO Annual Meeting
...(72%/71%),dysphagia (65%/63%), asthenia (56%/49%), nausea (49%/37%),constipation (35%/30%) and vomiting (29%...%), asthenia/malaise(73%/48%), diarrhea (72%/25%), nausea (55%/29%), abdominal pain(45%/26%), vomiting (41%/25%), fever (34%/27%), constipation(30%/26%), and ......e 15symptom scales, including pain (p<0.0001), nausea (p<0.0001)and global health status (p=0.047). “The first set of data from the EPIC trial demonstratedthat progression-free survival and tumor shrinkage increasedsignificantly when Erbitux was administered to this patientpopulation. It is t......nthe enhanced protection from chemotherapy-induced nausea andvomiting (CINV) observed with Aloxi in clinical...r rescue medication), no emesis, and nosignificant nausea (Visual Analogue Score (VAS; 0-100) less than25) on Day 1, during the delayed period of Days 2-5, an...Clinical Data Reported on Vidaza in Hematologic Malignancies and Advanced Solid Tumors
...mmonly occurring adversereactions by SC route were nausea (70.5%), anemia (69.5%),thrombocytopenia (65.5%), ... the mostcommonly occurring adverse reactions were nausea (70.5%), anemia(69.5%), thrombocytopenia (65.5%), vomiting (54.1%), pyrexia(51.8%), leukopenia (48.2......n the enhanced protection fromchemotherapy-induced nausea and vomiting (CINV) observed with Aloxiin clinical...r rescue medication), no emesis, and nosignificant nausea (Visual Analogue Score (VAS; 0-100) less than25) on Day 1, during the delayed period of Days 2-5, an......t for the prevention of chemotherapy-induced nausea and vomiting associated with carboplatin-containing chemotherapy regimen in patients with ovarian cancer, primary peritoneal or fallopian tube carcinoma (stage I-IV) or papillary serous cancer of the uterus -- Craig Reynolds, M.D......rted adverse eventswere asthenic conditions (64%), nausea (55%) in single-agentVELCADE, diarrhea (52%), constipation (41%), peripheral neuropathy(39%), thrombocytopenia (36%), appetite decrease, including reportsof anorexia (36%), pyrexia (34%), vomiting (33%) and anemia (29%).Twenty percent of patients rep......in the ONTAK-treated patientsincluded fever (56%), nausea (54%), fatigue (45%), rigors (45%),headache (27%), vomiting (25%), peripheral edema (23%), rash (22%),diarrhea (22%), myalgia (19%), cough (19%), asthenia (18%),pruritus (17%), back pain (17%), anorexia (15%), arthralgia (14%)and upper respiratory tr......grade 3 or 4gastrointestinal toxicities, including nausea (1.3%), vomiting(1.6%), diarrhea (2.1%) and constipation (2.1%). Additionally, 5%or less of patients in the satraplatin arm experienced grade 3 or 4fatigue (1.7%), grade 3 or 4 infections (4.0%) andpulmonary/respiratory grade 3 or 4 toxicities (3.0%)......grade 3 or 4gastrointestinal toxicities, including nausea (1.3%), vomiting(1.6%), diarrhea (2.1%) and constipation (2.1%). Additionally, 5%or less of patients in the satraplatin arm experienced grade 3 or 4fatigue (1.7%), grade 3 or 4 infections (4.0%) andpulmonary/respiratory grade 3 or 4 toxicities (3.0%)......or fatigue. Thepercentage of patients with grade 0 nausea (N), vomiting (V),diarrhea (D) and fatigue (F) for lower dose perifosine (76patients) was 46, 49, 38 and 55% respectively compared to 26, 32,20 and 58 percent for higher dose perifosine (69 patients). Theproportion of patients with grade 2+ N, V, D a...Lilly Studies Try to Shed Light on Impact of Race on Lung Cancer Treatment
...penia (2%); fatigue(17%); thrombsis/embolism (6%); nausea (12%); vomiting (11%);dyspnea (11%); and chest pai...ades) were fatigue (80%);thrombosis/embolism (7%); nausea (84%); vomiting (58%);constipation (44%); anorexia (35%); stomatitis/pharyngitis (28%);diarrhea (26%...... somnolence (27 percent), fatigue (9.4 percent)and nausea (5.1 percent). Small to modest changes in bloodpressure, pulse rate, and ECG were observed with GXR but were notclinically meaningful. Long-Term ADHD Symptom Improvement with GXR Trial 303 was a long-term, open-label, safety follow-up study of240 p...Investigational Study Evaluates the Effectiveness of Aripiprazole in Adolescents With Schizophrenia
...renia or bipolar mania the following was reported: nausea (9% vs 3%). Treatment-emergent adverse even..., anxiety (20% vs 17%), insomnia (19% vs 14%), nausea (16% vs 12%), vomiting (12% vs 6%), dizziness (11% vs 8%), constipation (11% vs 7%), dyspepsia (...Study Suggests Strattera Improved ADHD Symptoms in Patients With Comorbid Alcohol Abuse
...cal studies wereupset stomach, decreased appetite, nausea and vomiting, dizziness,tiredness and mood swings. In adults, the most common side effectswere constipation, dry mouth, nausea, decreased appetite,dizziness, problems sleeping, sexual side effects, problemsurinating and menstrual cramps. For Medicat...... trial were decreasedappetite, headache, insomnia, nausea and vomiting. Boys in theDAYTRANA group had a higher incidence of vomiting (9 boys vs. 1girl), tic (7 vs. 0), upper abdominal pain (6 vs. 1), irritability(7 vs. 0) and affect lability (6 vs. 0). The study was supported by funding from Shire. About ......), eructation (16% vs. 15%), pain (14% vs. 8%) and nausea (13%vs. 15%); for the maintenance of remission of UC, the most frequentadverse events were headache (50% vs. 50%), rhinitis (42% vs. 36%),diarrhea (35% vs. 50%), abdominal pain (32% vs. 44%) and flatulence(24% vs. 30%). Asacol is contraindicated in ......ost frequent treatment-emergentadverse events were nausea and headache. Nausea generally wastransient, usual...te/desvenlafaxine succinate group. Theincidence of nausea was highest for the placebo/desvenlafaxinesuccinate group during the first week of treatment and dec......grade 3 or 4 gastrointestinaltoxicities, including nausea (1.3%), vomiting (1.6%), diarrhea(2.1%) and constipation (2.1%). Five percent or less of patients inthe satraplatin arm experienced grade 3 or 4 fatigue, grade 3 or 4infections and pulmonary/respiratory grade 3 or 4 toxicities. About Satraplatin Sa......renia or bipolar mania the following was reported: nausea (9% vs 3%). Treatment-emergent adverse ev...anxiety (20% vs 17%), insomnia (19% vs 14%), nausea (16% vs 12%), vomiting (12% vs 6%), dizziness (11% vs 8%), constipation (11% vs 7%), dyspepsia...FDA approves IND on Lead Product M6G
...phine but inducedsignificantly less post-operative nausea and vomiting (PONV). Theopening trial under this I...n the unpleasant sideeffects experienced, of which nausea and vomiting are the mostcommon. PONV is rated among patients as one of the most distressingafter-ef......NICAR HCT and more frequently than placeboincluded nausea (3 percent vs 0 percent), hyperuricemia (4 percentvs 2 percent), dizziness (9 percent vs 2 percent), and upperrespiratory tract infection (7 percent vs 0 percent). No initial dosage adjustments are recommended with BENICAR inelderly, in moderate to ......ion (24 mcgBID), the most common adverse event was nausea (31%). Other adverseevents (greater than or equal to 5% of patients) included diarrhea(13%), headache (13%), abdominal distention (7%), abdominal pain(7%), flatulence (6%), sinusitis (5%) and vomiting (5%). For full prescribing information, visi......related adverse events in U.S. clinicaltrials were nausea (1.5%) and diarrhea (1.2%). The safety andefficacy of LEVAQUIN in pediatric patients, adolescents (under 18),pregnant women, and nursing mothers have not been established.LEVAQUIN is contraindicated in persons with a history ofhypersensitivity to LEV......ain, have trouble breathing, have stomach painwith nausea and vomiting, feel cold -- especially in their arms andlegs, feel dizzy or lightheaded, or have a fast or irregularheartbeat, as they may be signs of a serious condition calledlactic acidosis (buildup of an acid in the blood). Lactic acidosis is a m......8.4 percent), fever (10.3percent vs. 8.6 percent), nausea (4.2 percent vs. 4.1 percent),pruritis (3.1 percent vs. 2.8 percent) and dizziness (2.8 percentvs. 2.6 percent). Dosage and administration for GARDASIL GARDASIL is a ready-to-use, three-dose, intramuscular vaccine.GARDASIL should be administered in...Salix Pharmaceuticals Previews Digestive Disease Week 2007
... headache(8%); abdominal pain (6%); diarrhea (5%); nausea (5%); vomiting(4%); respiratory infection (4%); an...als, abdominaldistension, anal discomfort, thirst, nausea and abdominal pain weresome of the most common adverse reactions to MOVIPREPadministration. Vomiting......alleviating the symptoms of migraines suchas pain, nausea and sensitivity to light and sound. Although barbiturates and opioids are considered effective forshort-term migraine relief, many doctors recommend againstprescribing them for long-term use because of the potential foraddiction and abuse. Phys...BDSI Announces Positive Key Secondary Efficacy Endpoint Results for Bema Fentanyl
...her acute treatmentopportunities such as insomnia, nausea and vomiting, andinfections. The company's headquarters are located in Morrisville,North Carolina and its principal laboratory is located in Newark,New Jersey. For more information please visitwww.bdsinternational.com. Forward-Looking Statements No...New England Journal of Medicine Publishes New Data on Gardasil, Merck's Cervical Cancer Vaccine
...8.4 percent), fever (10.3percent vs. 8.6 percent), nausea (4.2 percent vs. 4.1 percent),pruritis (3.1 percent vs. 2.8 percent) and dizziness (2.8 percentvs. 2.6 percent). Dosage and administration for GARDASIL GARDASIL is a ready-to-use, three-dose, intramuscular vaccine.GARDASIL should be administered in...Data Suggest Cymbalta Reduced Severity of Night Pain in Patients with Diabetic Nerve Pain
...rse event cited as areason for discontinuation was nausea (4 percent), followed bysomnolence (2 percent), dizziness (2 percent), fatigue (1 percent)and vomiting (1 percent). Methods: Data were pooled from three double-blind, randomized,placebo-controlled, 12-week studies, to investigate associationsbetwee......esufferers experience traditional symptoms such as nausea orsensitivity to light and sound, migraine attacks...atients experienced traditional migraine symptoms: nausea (27-33percent), sensitivity to light (69-74 percent) and sensitivity tosound (62-69 percent). Additi......ypomagnesemia, paronychia,fatigue, abdominal pain, nausea and diarrhea. Hypomagnesemiaoccurred 6 weeks or longer after the initiation of Vectibix. Insome patients, hypomagnesemia was associated with hypocalcemia. Vectibix is indicated for the treatment of EGFr-expressing,metastatic colorectal cancer with d......ent). The most common side effects included nausea (13 percent), dizziness (13 percent), drowsiness (10 percent), and vomiting (5 percent). Of the 102 patients included in the safety evaluation, 12 withdrew from the study due to adverse events during the titration phase; none were ...BDSI Announces Positive Phase III Clinical Trial Results for BEMA Fentanyl
...her acute treatmentopportunities such as insomnia, nausea and vomiting, andinfections. The company's headquarters are located in Morrisville,North Carolina and its principal laboratory is located in Newark,New Jersey. For more information please visitwww.bdsinternational.com. Forward-Looking Statements No...Idenix Announces Data Presentations at the 2007 Digestive Disease Week Meeting
...(11%), blood CPK increased (9%), cough (7%), nausea and vomiting (7%), influenza and influenza-like symptoms (7%), post-procedural pain (7%), diarrhea and loose stools (7%), and pharyngolaryngeal pain (5%). -- Grade 3-4 creatine kinase (CK) elevations occurred in 9% of TYZEKA- tre......rted adverse eventswere asthenic conditions (64%), nausea (55%), diarrhea (52%),constipation (41%), peripheral neuropathy (39%), thrombocytopenia(36%), appetite decrease, including reports of anorexia (36%),pyrexia (34%), vomiting (33%) and anemia (29%). Twenty percent ofpatients reported at least one episo...