ライフサイエンスコーパス: safety

1 4 points in the WI-NRS score at week 12, and safety.

2 en evoked during threat and inhibited during safety.

3 owder reservoir patch delivery showed a good safety.

4 based), its cost-effectiveness and long-term safety.

5 DOR), clinical-benefit rate, biomarkers, and safety.

6 latile anaesthetics, thereby improving their safety.

7 patient-reported outcomes, tolerability, and safety.

8 owever, few data support its feasibility and safety.

9 ated patients were analysed for activity and safety.

10 g radiation exposure, and increasing patient safety.

11 s, providing reassuring data on efficacy and safety.

12 s evaluating its efficacy, tolerability, and safety.

13 survival, and progression-free survival and safety.

14 r society and future improvements in nuclear safety.

15 surgeon proficiency and may threaten patient safety.

16 understanding of this potential risk to food safety.

17 m outcomes, including efficacy and long-term safety.

18 e is widespread and consequential for public safety.

19 learer guidance regarding its cardiovascular safety.

20 ary end points included overall survival and safety.

21 emain attractive given their cost and retina safety.

22 ned beverages, have raised interest in water safety, access, and consumption.

23 PFA) is a nonthermal energy that may provide safety advantages over radiofrequency ablation (RFA).

24 ith a centrally confirmed BRCA mutation, and safety analyses included all patients who received at le

25 feeding at day 42, but were included in the safety analyses.

26 th data available for the primary endpoints; safety analysis included all randomly assigned patients

27 We present an integrated efficacy and safety analysis of patients with metastatic or locally a

28 d all assigned patients were included in the safety analysis.

29 In this subgroup analysis, we focused on the safety and activity of enasidenib as main outcomes.

30 Overall safety and activity of liso-cel did not differ by dose l

31 This study was done to assess the long-term safety and activity of siltuximab over up to 6 years of

32 tre, phase 1 clinical trials to evaluate the safety and antileukaemic activity of UCART19.

33 mmune cell therapies, increasing potency and safety and broadening their potential for treatment of d

34 To assess the safety and clinical outcomes of multi-probe stereotactic

35 e data provide a 10-year interim analysis of safety and effectiveness in TOP.

36 The safety and effectiveness of dual therapy (direct oral an

37 tention-to-treat population was used for the safety and efficacy analyses; all analyses, and their ti

38 Safety and efficacy are summarized for the initial 48 we

39 Safety and efficacy assessment of a hypocaloric HP-diet

40 e aim of this study was to provide long-term safety and efficacy data for evolocumab in patients with

41 ustained-release of GRFT, and to examine its safety and efficacy in a murine model of lethal HSV-2 in

42 senchymal stem cell (MSCs), we evaluated the safety and efficacy of an allogenic MSC-based intramamma

43 This study evaluates the safety and efficacy of an intracameral combination of 2

44 ndomised controlled trials have compared the safety and efficacy of any integrase inhibitor to efavir

45 The long-term safety and efficacy of apomorphine sublingual film are c

46 In this study, we assessed the safety and efficacy of apomorphine sublingual film as an

47 In this article, we have assessed the safety and efficacy of belimumab, a fully human IgG1 mon

48 Our understanding of the safety and efficacy of cannabis has been limited by deca

49 le with HIV, the increasing evidence for the safety and efficacy of immunotherapies in the context of

50 Data on the safety and efficacy of IPT in pregnant women living with

51 We evaluated the safety and efficacy of pegcetacoplan, a complement C3 in

52 d controlled trials (RCTs) investigating the safety and efficacy of systemic treatments for AD up to

53 We sought to evaluate safety and efficacy of the JAK1/2 inhibitor ruxolitinib

54 Our multicenter trial demonstrated safety and efficacy of transplantation of 30 HCV-viremic

55 n proprietary vaccines and allows the bar on safety and efficacy to be lowered, risking people's heal

56 y considered the gold standard for assessing safety and efficacy, CTs, especially phase III CTs, are

57 velopment and our approach to optimizing for safety and efficacy.

58 een instrumental in demonstrating short-term safety and efficacy; however, most patients do not have

59 highly desirable for the purpose of nuclear safety and environmental protection, but currently not a

60 The primary objectives were to assess the safety and evaluate the efficacy and stability of bioche

61 Anetumab ravtansine exhibited a manageable safety and favorable pharmacokinetic profile with encour

62 ormed a phase 1 clinical trial to assess the safety and feasibility of fecal microbiota transplantati

63 This study assessed the safety and feasibility of temporary percutaneous electri

64 The study had 2 primary analysis groups: safety and hemostatic efficacy.

65 Interim safety and immunogenicity data about the vaccine candida

66 1222), in young adults, and now describe the safety and immunogenicity of this vaccine in a wider ran

67 alent recombinant influenza vaccine [RIV4]), safety and immunogenicity trial of qNIV (in 5 different

68 cipants per group), not included in the main safety and immunological analysis, received HD-MAPs deli

69 Primary endpoints were safety and infectivity of the new isolate.

70 For more safety and longer survival, blood loss, bile leakage, an

71 This study assesses the safety and outcomes of the largest cohort of pancreatect

72 The aim of this study was to investigate the safety and performance of the second generation of an im

73 We obtained descriptive safety and pharmacokinetics statistics, and estimated ef

74 endations for needed interventions to ensure safety and review best practices and US regulatory requi

75 xidized functionalities, as well as in their safety and scalability.

76 Methods: Safety and survival of patients with metastatic castrati

77 his review summarizes the clinical efficacy, safety and tolerability of pitolisant in treating the sy

78 A detailed assessment of safety and tolerability of the study drugs was done in a

79 Safety and tolerability were similar to placebo.

80 Primary endpoints were safety and tolerability, and 12-week disease control rat

81 entation and access, street furnishings, and safety and traffic calming measures.

82 We are studying the safety and utility of (89)Zr-IAB22M2C, a radiolabeled mi

83 The primary endpoint was safety and we observed 6 of 28 patients (21%) with grade

84 the fields of environmental monitoring, food safety, and clinical diagnosis.

85 estimate that confidence in the importance, safety, and effectiveness of vaccines fell in Afghanista

86 ium.Objectives: To evaluate the feasibility, safety, and initial outcomes of bronchial rheoplasty in

87 This study reports immunogenicity, safety, and interchangeability of a single-dose, inactiv

88 enges in achieving high energy density, high safety, and long cycle life.

89 f the study was to evaluate the possibility, safety, and outcomes of pregnancy after TMVI in this pop

90 , freedom from non-protocol hormone therapy, safety, and patient-reported outcomes.

91 th unclear impacts on human physiology, drug safety, and response.

92 fraction with T2DM to assess their efficacy, safety, and risk-benefit profile.

93 The primary outcome of the study was safety, and secondary outcomes included visual acuity, m

94 Our aim was to determine the efficacy, safety, and tolerability of berotralstat in patients wit

95 chanisms that could yield superior efficacy, safety, and tolerability.

96 mized clinical trials (AMAGINE -1 [Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab i

97 ials and is being evaluated for efficacy and safety as monotherapy in patients with mild to moderate

98 didates are important for their efficacy and safety as therapeutics.

99 matic, virologically confirmed COVID-19, and safety, as measured by the occurrence of serious adverse

100 Co-primary endpoints were safety (assessed by incidence of adverse events) and pha

101 Although general aspects on the safety assessment of microbial cultures have been sugges

102 Nevertheless, ongoing safety assessments are important in sustaining vaccine u

103 Safety assessments were performed through week 18.

104 However, the enhanced safety benefits of iTrEnDi coupled with its ease of use

105 te to the impact of shift working on patient safety/care).

106 including Safety Emphasis subscales from the Safety Climate Scale, Face-Saving Scale, the Index of Hi

107 rging controls are used, alleviating a major safety concern (short-circuiting related to Li dendrite

108 s at the higher doses, there were no notable safety concerns after subretinal delivery of an adeno-as

109 herosclerotic cardiovascular disease without safety concerns around using aspirin and meeting trial e

110 ssociated with any statistically significant safety concerns in the population studied.

111 mumab-CyBorD was well tolerated, with no new safety concerns versus the intravenous formulation, and

112 s in all participants, and no trial-limiting safety concerns were identified.

113 episodes from all six CTG trials revealed no safety concerns when compared with the RGT.

114 of alendronate was well-tolerated, showed no safety concerns, and significantly improved LS and whole

115 y clinical trials from poor exposure to drug safety concerns, such as drug-induced liver injury (DILI

116 positive health impact and resolve remaining safety concerns, wider roll-out could be recommended fro

117 est drives, 16 (8.5%) were terminated due to safety concerns.

118 hat utilizes standing dead trees removed for safety concerns.

119 eatment of ulcerative colitis, but there are safety concerns.

120 rmation is critical to balance the competing safety considerations of reducing SARS-CoV-2 exposure an

121 valuate their biodistribution for health and safety considerations.

122 The effectiveness, safety, cost of care.

123 is safe and may reduce healthcare costs, 2) safety criteria should be provided, 3) a protocolized or

124 he inhibition of a conditioned response to a safety cue.

125 predict 135 adverse events using post-market safety data from marketed drugs.

126 The primary outcome was safety, defined as number of adverse events per total nu

127 ined in brief, as well as an introduction to safety designations and nomenclature put forth by the Am

128 e specifically impaired in rapid uncertainty-safety discrimination.

129 gineering strategies in order to improve the safety, efficacy and applicability of this therapeutic m

130 of autonomous AI, and understand its design, safety, efficacy and equity, validation, and liability,

131 providing accurate information about vaccine safety, efficacy, and timing in the pre- and posttranspl

132 Safety, efficacy, predictability, astigmatic vector chan

133 nts completed four questionnaires, including Safety Emphasis subscales from the Safety Climate Scale,

134 The primary safety end points were device related death or adverse e

135 Two primary safety end-point events occurred in the ablation group (

136 strategy on the combination of efficacy and safety events (net clinical benefit).

137 o major device-related or procedural-related safety events occurred up to 3 months.

138 Safety, feasibility, cognitive tests and MRI measures of

139 lant uninfected recipients while maintaining safety for health care systems in the backdrop of a viru

140 by energy resources disruption, and finally safety for human gut tissues.

141 why the intervention did or did not lead to safety improvements, and how this intervention can be ap

142 and evaluated the diagnostic performance and safety in a phase III study of patients with SSTR-expres

143 The primary endpoints (safety in GEN501 and overall response rate in SIRIUS) ha

144 accountable evidence on its suitability and safety in healthy infants.

145 e essential to depend on careful analysis of safety in humans as immune interventions for COVID-19 mo

146 February 2018, the Ministry of Food and Drug Safety in Korea approved tenofovir disoproxil fumarate a

147 eaningful, durable responses; and acceptable safety in primarily elderly patients with R/M cSCC, supp

148 After a mean follow-up of 12 months, the safety index was mean 1.40 +/- 0.70 in the T-ICL group a

149 h process such as bedside and research staff safety, infection control, the informed consent model, p

150 ore and during therapy for effectiveness and safety is recommended.

151 The most common safety issue triggering label modifications was expansio

152 No safety issues related with the technique were detected.

153 -related factor are associated with enhanced safety learning, as measured using a probabilistic compu

154 b bisphenol A, and 1 ppb paraoxon, tested as safety limits.

155 tandardisation and supporting flexibility in safety management.

156 ns involve rules of conduct, procedures, and safety measures that should be introduced in radiology d

157 oints included fatigue, sexual function, and safety measures.

158 The data and safety monitoring board halted the trial when the number

159 ta monitoring committees (DMCs), or data and safety monitoring boards, protect clinical trial partici

160 Substrate oxidation was unchanged, and safety monitoring revealed that the drug was well tolera

161 ent by improving patient selection criteria, safety monitoring, endpoint selection, and more.

162 early graft outcomes and the presence of a "safety net" would further encourage program participatio

163 SNAP) is the cornerstone of the US nutrition safety net.

164 and uninsured patients were categorized into safety-net burden (SNB) quartiles.

165 In 2017, the Health Center Program provided safety-net care to more than 27 million persons, includi

166 brain activation linked to insecurity (lower safety neural evoked responses during the video task and

167 Here, we evaluated the utility and safety of a new low-seroprevalence gorilla adenovirus (G

168 describe the duration of hospitalisation and safety of ambulatory management compared with standard c

169 d, Controlled Clinical Trial to Evaluate the Safety of Apixaban vs Vitamin K Antagonist and Aspirin v

170 We aimed to assess the efficacy and safety of atezolizumab (anti-PD-L1) alone and combined w

171 IMpassion031 compared efficacy and safety of atezolizumab versus placebo combined with nab-

172 However, the perioperative safety of bariatric surgery in this patient population i

173 ha antagonists, (2) comparative efficacy and safety of biologic monotherapy vs combination therapy wi

174 Evidence supports the efficacy and safety of both in-office and facility-based surgery for

175 vere Plaque Psoriasis], and -3 [Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinum

176 this review was to compare the efficacy and safety of conservative surgery with or without adjunctiv

177 In the United States, the efficacy and safety of convalescent plasma for treating coronavirus d

178 limited guidance on comparative efficacy and safety of different treatments, leading to considerable

179 clinical trials to evaluate the efficacy and safety of DOACs in patients with CAT.

180 Long-term efficacy and safety of Fluticasone propionate/formoterol fumarate hyd

181 We aimed to measure the efficacy and safety of gabapentin in women with chronic pelvic pain a

182 ist clinicians to promote the efficiency and safety of healthcare in the future.

183 hase 3 ASPEN study compared the efficacy and safety of ibrutinib, a first-generation BTK inhibitor, w

184 A phase 1 trial assessed the safety of intravitreal OPT-302 as monotherapy or combine

185 -year study to monitor the effectiveness and safety of IVT-AFL in patients with nAMD in clinical prac

186 rformed a trial to evaluate the efficacy and safety of IW-3718, a bile acid sequestrant, as an adjunc

187 We aimed to evaluate the efficacy and safety of ixekizumab, an IL-17 inhibitor, in non-radiogr

188 ol for the screening of both the quality and safety of ketchup samples.

189 Long-term safety of living kidney donation (LKD), especially for y

190 sess the terminal phase pharmacokinetics and safety of long-acting injectable cabotegravir in partici

191 n long-term outcome focusing on efficacy and safety of long-term use of rituximab maintenance.

192 We aimed to assess the efficacy and safety of mavacamten, a first-in-class cardiac myosin in

193 spective study, we compared the efficacy and safety of mechanical adjuvants in mucosal-sparing, mecha

194 aimed to assess the antitumour activity and safety of neoadjuvant chemoimmunotherapy for resectable

195 Herein, the 12-month efficacy and safety of netarsudil/latanoprost FDC are reported.

196 hase 2 trial to investigate the efficacy and safety of once-weekly insulin icodec as compared with on

197 3 clinical trial assessing the efficacy and safety of pembrolizumab versus placebo in combination wi

198 further determining the clinical utility and safety of pharmacological knockdown of HDAC8 in diseased

199 environment and test measures to improve the safety of shift workers.

200 s are necessary to evaluate the efficacy and safety of sodium phenylbutyrate-taurursodiol in persons

201 nalyses of these trials have established the safety of statins with regard to nonvascular mortality a

202 was to evaluate the feasibility and initial safety of the BEC in patients with acute intermediate-ri

203 nal framework exists in the EU to ensure the safety of the feed-food chain, while such an integrated

204 disposing factors for treatment response and safety of the intervention.

205 The reproducibility and safety of the method were validated by MRI and histology

206 tic anticoagulation postoperatively, yet the safety of this practice remains unknown.

207 application can be investigated, data on the safety of this technique is indicated.

208 We assessed the efficacy and safety of ticagrelor versus prasugrel in a head-to-head

209 ADVANCE compared the efficacy and safety of two antiretroviral first-line combinations (do

210 2 clinical study evaluated the efficacy and safety of VT-1161 versus fluconazole in subjects with mo

211 The Observational Study of the Use and Safety of Xolair (omalizumab) during Pregnancy (EXPECT)

212 diets reduced urinary sodium without adverse safety or quality of life signals, a larger trial, with

213 The percentage of patients with the primary safety outcome (a composite of death, serious adverse ev

214 efficacy outcome was stroke and the primary safety outcome was major bleeding.

215 ed by intention-to-treat), and the principal safety outcome, major or clinically relevant non-major b

216 We examined clinical safety outcomes (mortality, complications, and reinterve

217 Primary safety outcomes included cumulative incidence rates for

218 Safety outcomes included death, severe disability or dea

219 Prespecified safety outcomes included major bleeding (fatal, critical

220 Systematic collation of certain important safety outcomes was rare.

221 663 patients were included and assessed for safety outcomes.

222 ce risk measures and health care quality and safety outcomes.

223 of general well-being and other clinical and safety outcomes.

224 about facility-level variation in short-term safety outcomes.

225 condary end points included angiographic and safety outcomes.

226 ndpoints analysed within this report include safety, overall survival, and duration of response, in k

227 The food safety parameters and contaminants (PAH, 3-MCPD ester, 2

228 ns have shown advantages in tolerability and safety, particularly in the treatment of older patients

229 from scientists for the advantages of better safety performance.

230 The safety population included patients who received any dos

231 At Week 48, DOR at 100 mg had a favorable safety profile compared with EFV or DRV+r and a favorabl

232 The possibility of an ameliorated safety profile driven by significantly selective (>100-f

233 hritis signs and symptoms with an acceptable safety profile in a phase 2 trial.

234 MTP(10)-HDL's favorable biodistribution and safety profile in non-human primates.

235 ve as single-agent therapy with a manageable safety profile in patients with treatment-naive, or rela

236 dditionally, compound 28 has shown excellent safety profile in phase 1 clinical trials and is being e

237 ective study was to compare the efficacy and safety profile of a single XEN-microstent in different t

238 The safety profile of BNT162b2 was characterized by short-te

239 icity in mice, demonstrating the exceptional safety profile of the vector vis-a-vis systemic utility.

240 at displayed excellent potency, selectivity, safety profile, and efficacy in vivo.

241 l complete response rates with an acceptable safety profile.

242 overall response rate of 93% and an expected safety profile.

243 50 compared with placebo, with an acceptable safety profile.

244 , is noninferior to sorafenib and to compare safety profiles for patients with advanced HCC.

245 s well as more favorable pharmacokinetic and safety profiles than IP6 after subcutaneous injection.

246 The 2 MIGS devices have similar safety profiles.

247 ynergistic anti-tumor efficacy with improved safety profiles.

248 lation allows PV isolation with good chronic safety; PV isolation success is improving with device en

249 SARs) 2-3 orders of magnitude lower than the safety regulation limit.

250 Considering work-safety regulations, we will identify immanent noise patt

251 valence and characteristics of postapproval, safety-related label changes.

252 There were 58 postapproval, safety-related label modifications associated with 25 va

253 ex critical care events that present patient safety-related risk.

254 and precautions, 8 contraindications, and 1 safety-related withdrawal).

255 However, its efficacy and safety remain unclear.

256 primary surrogate end points of efficacy and safety, respectively.

257 Here we report updated efficacy and safety results from a prespecified, interim, overall sur

258 ts through 96 weeks support the efficacy and safety results reported previously for doravirine at 48

259 reports, and assessments from an independent Safety Review Committee (SRC); and (3) their clinical ex

260 We report results of the 28-patient safety run-in.

261 protocol analysis, and 20 071 (99.9%) in the safety set.

262 zation involving impaired fear regulation by safety signals.

263 Due to their safety, specificity, and potential for rapid advancement

264 In early nonclinical research, discovery and safety studies are normally undertaken separately.

265 rs from a traditional phase III efficacy and safety study in the development of a novel biologic orig

266 rospective cohort trial is the first phase 3 safety study to describe outcomes in children treated wi

267 Secondary outcomes were safety, survival, and functional assessment at hospital

268 interleukin-15, and inducible caspase 9 as a safety switch.

269 to better understand how to improve surgical safety, they have rarely been done.

270 his approach will add an additional level of safety to cell therapies and therefore enable the develo

271 of different formulations support equivalent safety to placebo with less toxicity than oral iron.

272 ging from on-site skin care testing, to food safety to the most frequent in vitro diagnostic tests, p

273 Here we report the available safety, tolerability and immunogenicity data from an ong

274 We aimed to evaluate the safety, tolerability, and antitumour activity of margetu

275 The safety, tolerability, and efficacy of a single IVT brolu

276 d, placebo-controlled study investigated the safety, tolerability, and pharmacokinetics of nilotinib,

277 Therefore, we evaluated the safety, tolerability, pharmacokinetic (PK), pharmacodyna

278 gh-dose intravenous immunoglobulin (IVIg) on safety, tolerability, pharmacokinetics (PK), and pharmac

279 ma tissue influence the hydraulic efficiency-safety trade-off in the basal angiosperms.

280 decitabine exposure, DNA demethylation, and safety vs decitabine 20 mg/m2 IV in the first 2 cycles,

281 Safety was analysed in all participants who received at

282 Safety was analyzed in all patients who received at leas

283 Safety was assessed in all participants who received at

284 Safety was assessed in all patients for whom study treat

285 Safety was assessed in all patients who had received at

286 Safety was assessed in all patients who received at leas

287 Safety was assessed in all patients who received at leas

288 Safety was assessed in all patients who received study d

289 Safety was assessed in the modified intention-to-treat p

290 Safety was assessed up to 48 h post-injection.

291 Overall safety was comparable between OH+ (n = 288, 27.5%) and O

292 tbreak strain") were determined, and vaccine safety was evaluated.

293 Activity and safety were assessed in the modified intention-to-treat

294 with a simple battery configuration and high safety, which is different from traditional molten-salt

295 umab q12-week regimen maintains efficacy and safety while reducing treatment burden associated with r

296 EHR-related intervention to improve patient safety, why the intervention did or did not lead to safe

297 However, long-term safety will hinge upon the prevalence of geochemically r

298 This study demonstrates high efficacy and safety with contemporary S-ICD devices and programming d

299 T did not show any improvement in outcome or safety with the use of DC compared with anthracycline-ba

300 essure adaptation are also important in food safety, with the increasing use of high-pressure food pr