ライフサイエンスコーパス: adverse event

1 2W group had at least one treatment-emergent adverse event.

2 Anemia was the main adverse event.

3 r two of the four patients developed serious adverse events.

4 s associated with an increased risk of major adverse events.

5 n-free survival and was associated with more adverse events.

6 s associated with transient mild to moderate adverse events.

7 difference in positive microbial cultures or adverse events.

8 (3.3%) vs 9 (6.1%) experienced other serious adverse events.

9 (9%) patients had serious treatment-related adverse events.

10 fined by the Common Terminology Criteria for Adverse Events.

11 ICU discharge date to identify and classify adverse events.

12 Four subjects withdrew due to adverse events.

13 st be weighed against its cost and potential adverse events.

14 rs for discontinuation due to inefficacy and adverse events.

15 rding to the Common Terminology Criteria for Adverse Events.

16 of 59 patients in the azathioprine group had adverse events.

17 on cardiac contractility can lead to serious adverse events.

18 linical failure, microbiological failure, or adverse events.

19 nt neointima after stenting, associated with adverse events.

20 ents) or nonrespiratory (27.9%, 43 patients) adverse events.

21 rican Thyroid Association guidelines and the adverse events.

22 he number and severity of treatment-emergent adverse events.

23 condary endpoints were treatment failure and adverse events.

24 There were no fatal adverse events.

25 ects completed the study without any serious adverse events.

26 , discontinuation, mortality, and individual adverse events.

27 sure of cancer therapies can induce unwanted adverse events.

28 ion rates and dropout/discontinuation due to adverse events.

29 hPSCs), unwanted tissues, and other types of adverse events.

30 s (n = 5) had treatment-related grade 3 or 4 adverse events.

31 of study drug in terms of treatment-emergent adverse events.

32 ty, as measured by the occurrence of serious adverse events.

33 occurring, yet preventable hospital-acquired adverse events.

34 ificant between-group differences in serious adverse events.

35 gression were conducted to assess risk of GI adverse events.

36 0-mug dose group reported one or more severe adverse events.

37 tibodies, which often inflict immune-related adverse events.

38 nal management, with a lower risk of serious adverse events.

39 ded cumulative incidence rates for (serious) adverse events.

40 linically relevant treatment-related serious adverse events.

41 to identify the risk factors associated with adverse events.

42 decreases in LOS had a higher risk of severe adverse events [1.22 (1.11-1.34)] and death [1.17 (1.04-

43 3/98] vs 25.5% [25/98]; P = .01) and serious adverse events (27.6% [27/98] vs 12.2% [12/98]; P = .012

44 Few participants in either group had serious adverse events (3 [2.4%] vs. 5 [4.0%]).

45 There were no differences in the rate of adverse events (3 in the CMR group and 2 in the PVI-alon

46 roportions of participants with Grade 3 or 4 adverse events (43.9% [43/98] vs 25.5% [25/98]; P = .01)

47 n follow-up of 6.6 years, there were 8 major adverse events: 6 relapses, 1 treatment-related death (f

48 he control group reported at least 1 serious adverse event (adjusted RR, 1.72 [95% CI, 0.7 to 4.3]).

49 1 [95% CI, 1.13 - 2.03], P=0.0058), and limb adverse events (adjusted HR, 8.37, P<0.001).

50 /SAM was generally well tolerated, with most adverse events (AEs) being mild or moderate in severity.

51 Seventy-seven percent of patients had adverse events (AEs) during open-label titration, most o

52 There were 3 grade 5 adverse events (AEs) in the SD arm and 9 in the HD arm.

53 Serious adverse events (AEs) occurred in 10% of imipenem/relebac

54 Grade 3 or 4 treatment-related adverse events (AEs) occurred in 75% and 87% of patients

55 nducted a disproportionality analysis of the adverse events (AEs) of EGFR-TKIs (gefitinib, erlotinib,

56 There were 277 mild adverse events (AEs) recorded through the passive pharma

57 Rates of adverse events (AEs) were similar between both groups.

58 through 100 days after HCT, and grade 3 or 4 adverse events (AEs) within 2 weeks after vaccination th

59 Detailed study of ophthalmic immune-related adverse events (AEs), including determination of inciden

60 Safety was assessed by adverse events (AEs), laboratory tests, and electrocardi

61 l reactions (LRs) and systemic events (SEs), adverse events (AEs), serious AEs, newly diagnosed chron

62 ere used to compare treatment completion and adverse events (AEs).

63 Pembrolizumab-related adverse events affected 71% of the patients, and 4 (7%)

64 Subdeltoid bursitis has been reported as an adverse event after intramuscular vaccination in the del

65 xisting evidence for serious and non-serious adverse events after ivermectin exposure in pregnant wom

66 Five adverse events (all grade 3) were assessed as being poss

67 sual acuity, central subfield thickness, and adverse events also were collected.

68 Adverse events, although mild, were more common in both

69 One adverse event (an allergic reaction) was reported in 1 p

70 e for the development of this immune-related adverse event and to ultimately predict or prevent its d

71 ytokine release syndrome was the most common adverse event and was observed in 19 patients (91%); thr

72 k PE, there were no deaths or device-related adverse events and a significant reduction in right vent

73 Safety was evaluated by adverse events and ACM through follow-up.

74 ella use was associated with higher rates of adverse events and costs.

75 (HCC) because of the potential for profound adverse events and large variations in survival outcome.

76 lerated a total of 17 FUS treatments with no adverse events and neither cognitive nor neurological wo

77 There were no drug-related serious adverse events and no treatment-related deaths.

78 Adverse events and pharmacokinetic measurements were ass

79 Adverse events and serious adverse events were minimal,

80 28 days after each dose, including solicited adverse events and serious adverse events, and immunogen

81 points were safety (assessed by incidence of adverse events) and pharmacokinetics (assessed by serum

82 t solid organ transplants, recent reports of adverse events, and ethical and regulatory consideration

83 cluding solicited adverse events and serious adverse events, and immunogenicity (seroprotection rates

84 fety end points were device related death or adverse events, and major bleeding within 72 hours after

85 Adverse events are common after ICU discharge to hospita

86 No grade 3 or higher adverse events are seen.

87 the probable cause for grade 3-4 hematologic adverse events, as they occurred before CAR-NKT cell inf

88 and 2 and treatment-associated grade 3 or 4 adverse events at least possibly related to study treatm

89 >=75 years were also more likely to have an adverse event attributable to TB medication and were mor

90 oled proportion for grade 3-4 cardiovascular adverse events, based on 77 studies (n=14 351 patients),

91 There was no difference in adverse events between randomised groups.

92 BCAR) within 60 weeks after transplantation; adverse event coding was centralised.

93 d with an increased risk of death or serious adverse events compared with allopurinol.

94 Adverse events consisted primarily of elevated liver tes

95 patients (21%) with grade >=3 immune-related adverse events, consisting of asymptomatic laboratory ab

96 Adverse events could be minimised by using non-isoniazid

97 rding to the Common Terminology Criteria for Adverse Events (CTCAE), version 5, and its relationship

98 rated by the Common Terminology Criteria for Adverse Events (CTCAE; v4.03) classification.

99 Combined adverse event data and BCAR episodes from all six CTG tr

100 les that include the incidence of high-grade adverse events, defined by the Common Terminology Criter

101 At least 1 serious adverse event developed in 12 patients (24%) in the ritu

102 the placebo group (with 6 infectious serious adverse events developing among 4 patients [9%]).

103 Proportions of patients with adverse events did not differ significantly among groups

104 fined by the Common Terminology Criteria for Adverse Events, do not provide information on the time p

105 Incidences of adverse events, drug continuation, implantable cardiover

106 adverse event (OR 1.55, 95% CI: 1.03-2.33), adverse events due to decreased appetite (OR 3.56, 95% C

107 Many adverse events during surgery occur due to errors in vis

108 Among participants with adverse events, eight participants (six participants in

109 sthetic joint infections (PJI) are a serious adverse event following joint replacement surgeries; ant

110 Adverse events from these agents might affect the abilit

111 Maternal adverse events from treatment were infrequent and minor

112 Primary endpoints were adverse events (grade 3 or higher) and dolutegravir popu

113 biological and pharmacokinetic measures, and adverse events graded 2 or higher.

114 atezolizumab died due to a treatment-related adverse event (haemophagocytic syndrome).

115 Medical prevention of adverse events has increased considerably over time in p

116 lozin versus placebo including limb ischemic adverse events (HR, 1.07 [95% CI, 0.90-1.26]) and amputa

117 to lack or loss of efficacy in 74 patients, adverse event in 34 patients, and sustained quiescence i

118 The primary outcome was any severe adverse event in a per patient analysis.

119 randomised to rosuvastatin, and one serious adverse event in each group.

120 Pneumonia was the only serious adverse event in more than 2% of patients (seven [3%] in

121 one death resulting from a treatment-related adverse event in the subcutaneous daratumumab group (feb

122 Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) pat

123 No severe adverse events in any patient were deemed likely related

124 e most common grade 3 or 4 treatment-related adverse events in both safety populations were increased

125 explored, but they have been associated with adverse events in clinical trials.

126 the incidence of reported episodes of AF/AFL adverse events in high-risk patients with type 2 diabete

127 Serious treatment-emergent adverse events in more than one patient were pneumonia (

128 rmal drug taste." The most commonly reported adverse events in patients aged 6 to <12 years were vomi

129 The absence of adverse events in patients imaged under DBS vendor guide

130 CTs) and observational studies that reported adverse events in pregnant women.

131 The most commonly reported adverse events in the CGM and BGM groups were severe hyp

132 The most common adverse events in the intensive treatment and standard t

133 e were ten (43%) grade 3-4 treatment related adverse events in the ipilimumab group, three (16%) in t

134 The most common treatment-emergent adverse events in the ixekizumab groups were nasopharyng

135 Serious adverse events in the lower-threshold group included con

136 event POAF and to decrease the risk of major adverse events in these high-risk patients.

137 Serious adverse events included 1 suicide attempt, related to co

138 The outcomes of these serious adverse events included 16 deaths, 4 of which were compl

139 Adverse events included rearrest, pulmonary edema on che

140 patients, treatment-related grade 3 or worse adverse events included thrombocytopenia (three [3%]), n

141 Adverse events included transient symptoms of hypomania,

142 cacy, there is also the potential for severe adverse events, including cytokine release syndrome (CRS

143 incident tuberculosis cases, and additional adverse events increased with age.

144 Adverse event information available from FDA product lab

145 However, immune-related adverse events (irAEs) and the risk of infections are no

146 ommonly evoke a wide range of immune-related adverse events (irAEs) that can affect any organ system

147 ncy, phenotypes, co-occurring immune-related adverse events (irAEs), and long-term outcomes of severe

148 ors have been associated with immune-related adverse events (irAEs), immune toxicities thought to be

149 -limiting toxicity (DLT) from immune-related adverse events (irAEs).

150 Clinical response, adverse events, laboratory results, imaging and liver bi

151 B medication and were more likely to have an adverse event later in therapy.

152 In the run-in period, 4 patients had adverse events leading to the discontinuation of rilonac

153 The frequency of adverse events leading to treatment discontinuation was

154 ept group than in the placebo group, and few adverse events led to the discontinuation of treatment.

155 nts for severe (grade 3 or 4) immune-related adverse events like neurotoxicity and pneumonitis.

156 Treatment-related adverse events (mainly mild or moderate local reactions)

157 Costs contained drugs, monitoring and adverse events measured in US Dollars.

158 or trial registration, and poor reporting of adverse events, methods of sequence generation and alloc

159 was safe, with no treatment-related serious adverse events observed.

160 At least one adverse event occurred during the trial in 22 participan

161 Results: No adverse events occurred after injection of (18)F-SKI.

162 Serious adverse events occurred equally between groups.

163 Nonfatal serious adverse events occurred in 12/72 (16.7%) in the oral gro

164 In IPV-vaccinated participants, solicited adverse events occurred in 16 (94%) of 17 who received n

165 Serious adverse events occurred in 22.7% and 21.7%, respectively

166 Treatment-related serious adverse events occurred in 25 (24%) patients and treatme

167 Grade 3 or 4 nonhematologic adverse events occurred in 25 patients (28%) on lenalido

168 s were 5(IQR: 4-6) and 6(IQR: 5-7) min, mild adverse events occurred in 4(9.4%) and 4(14.2%) of cases

169 Grade 3 to 5 treatment-related adverse events occurred in 5.7% (n = 6) of patients.

170 Treatment-related adverse events occurred in 66.7% of patients (n = 70), t

171 Grade 3-4 adverse events occurred in 71 (91%) of 78 patients in th

172 Adverse events occurred in 89.3% of patients, the most c

173 Grade 1-2 treatment-related adverse events occurred in 93% of patients, most commonl

174 No severe adverse events occurred in any of the procedures.

175 Treatment-related serious adverse events occurred in seven (12%) patients in the a

176 No intervention-related serious adverse events occurred, and few adverse effects occurre

177 No drug-related serious treatment-emergent adverse events occurred.

178 e rituximab group (with 9 infectious serious adverse events occurring among 6 patients [12%]) versus

179 One 3-year-old patient had a serious adverse event of accidental ribavirin overdose requiring

180 The Data Collection on Adverse Events of Anti-HIV Drugs (DAD) study has reporte

181 The most common adverse events of grade 3 or higher were hypertension (i

182 Overall, 21 adverse events of grade 3 or higher were recorded.

183 The incidence of dental and skin adverse events of special interest was higher with the 1

184 (32%) patients experienced grade 3 or worse adverse events, of which the most common were anaemia (f

185 There were three adverse events (one episode of angina, one fall during a

186 ide information on the time profile of these adverse events or reflect the continuous, lower grade sy

187 No vaccine-related serious adverse events or severe dengue virus disease were repor

188 hioprine (AZA) or mercaptopurine (MP) due to adverse events or suboptimal response.

189 pneumonia (OR 5.37, 95% CI: 1.17-24.65), any adverse event (OR 1.55, 95% CI: 1.03-2.33), adverse even

190 ts (OR 2.65, 95% CI: 1.04-6.80), any serious adverse event (OR 2.30, 95% CI: 1.18-4.48), serious adve

191 eason (OR 2.61, 95% CI: 1.38-4.96) or due to adverse events (OR 2.65, 95% CI: 1.04-6.80), any serious

192 afety outcome (a composite of death, serious adverse events, or clinical grade 3 or 4 adverse events

193 ontributions to exPH independently predicted adverse events (p < 0.001 for both).

194 ary outcome was safety, defined as number of adverse events per total number of sessions.

195 itial complication may provoke a sequence of adverse events potentially leading to mortality after pa

196 duced durable responses and had a manageable adverse events profile in patients with relapsed or refr

197 acting immunosuppressive drugs with superior adverse event profiles, including biologics (in particul

198 Overall adverse event rate was 14% (43 of 307), including 11 gra

199 e tone averages (PTA), and procedure-related adverse events rated by the Common Terminology Criteria

200 ciated with similar hypertrophy severity and adverse event rates as observed with truncating variants

201 We compare adverse event rates associated with IV iron vs red cell

202 Adverse event rates at 3 years were higher for patients

203 Serious adverse event rates could not be determined with meta-an

204 ts implanted for at least 10 years, quantify adverse event rates, and identify predictive factors of

205 gan reducing payments to hospitals with high adverse event rates.

206 event (OR 2.30, 95% CI: 1.18-4.48), serious adverse events related to abnormal liver function tests

207 There were no adverse events related to contrast agent administration.

208 No adverse events related to the injection of (99m)Tc-PSMA

209 response rates and potential immune-related adverse events remain two major challenges.

210 b, osimertinib) by data mining using the FDA adverse event reporting system (AERS) database, and by c

211 e system, the WHO VigiBase, and from the FDA Adverse Event Reporting System), 87 from Boehringer Inge

212 As we discuss in this paper, adverse events represent a violation of the expectable e

213 e data at week 16-17, or sooner if a serious adverse event requiring knowledge of the study drug occu

214 All potentially related adverse events resolved without clinical sequelae.

215 Most adverse events resulted only in symptoms (77%) and 36% w

216 associated with a risk of procedural serious adverse events (SAE) and exposure to ionizing radiation.

217 The total incidence of AE and serious adverse events (SAE) was calculated.

218 comes, culture-conversion rates, and serious adverse events (SAEs) during treatment.

219 oints were solicited/unsolicited and serious adverse events (SAEs), biochemical/hematological paramet

220 These delayed and often lethal adverse events should be studied further to improve clin

221 No adverse events such as hypo/hyperpigmentation, skin infe

222 The most common treatment-emergent adverse events (TEAEs) across all groups were nausea (ra

223 ersensitivity" alone or in combination with "adverse events," "testing," "evaluation," "effects," "la

224 The most common grade 3-4 adverse events that occurred in the phase 2 single-agent

225 (11%) patients had serious treatment-related adverse events, the most common of which were nervous sy

226 y and simultaneously identify immune-related adverse events, there are several challenges in interpre

227 at were included had no reported significant adverse events, therefore, these 10 nonpharmacological i

228 ous adverse events, or clinical grade 3 or 4 adverse events through day 5) was similar in the LY-CoV5

229 Grade >=3 treatment-related adverse events (TRAEs) were experienced by 72% of patien

230 the most common grade 3-4 study drug-related adverse event (two [1%] of 157 patients, both grade 3),

231 Serious adverse events up to week 24 occurred in no patients rec

232 eloped a preliminary approach to predict 135 adverse events using post-market safety data from market

233 The most frequent adverse event was fatigue with a pooled prevalence of 16

234 The most common grade 3-4 adverse event was neutropenia (200 [49%] of 408 patients

235 At least one treatment-related serious adverse event was reported in 25 (10%) patients in the i

236 71-243.57) per 100 patient-years and serious adverse events was 12.63 (95% CI 11.41-13.94) per 100 pa

237 ocrelizumab exposure population, the rate of adverse events was 238.09 (95% CI 232.71-243.57) per 100

238 The frequency of participants experiencing adverse events was higher in the hydroxychloroquine grou

239 The incidence of serious adverse events was low and was similar in the vaccine an

240 ence in the incidence or severity of serious adverse events was reported during the follow-up period.

241 The number of serious adverse events was similar in both groups and unrelated

242 ntage of participants with local or systemic adverse events was similar in the two groups.

243 y a stepwise method to capture all available adverse events, we first extracted data on myelodysplast

244 e most frequently reported grade 3 or higher adverse events were abnormal blood chemistry results (33

245 Progression-free survival (PFS), OS, and adverse events were also assessed.

246 The most common grade 3-4 treatment-related adverse events were anaemia (four [4%]) and infusion-rel

247 tivity, endothelial cell count, and possible adverse events were assessed at least 12 months postoper

248 Adverse events were assessed for up to 28 days.

249 Serious adverse events were assessed in all women who received a

250 Adverse events were assessed up to 28 days.

251 No serious adverse events were attributed to dihydroartemisinin-pip

252 All patients had engraftment, and adverse events were consistent with effects of the prepa

253 Adverse events were consistent with those previously obs

254 Such adverse events were dose-dependent and were more common

255 The most common drug-related adverse events were fatigue, nausea, diarrhea, anorexia,

256 The most common grade 3-4 adverse events were febrile neutropenia (22 [66%]), bloo

257 Other adverse events were grade 1 or 2 neurotoxicity in eight

258 The most common (n>1) drug-related adverse events were headache (in nine [30%] participants

259 The most common grade 3 or 4 adverse events were hypertension (88 [27%] of 332 patien

260 r 100 patient-years; the most common serious adverse events were infections at 4.13 (95% CI 3.45-4.91

261 Drug-related adverse events were less common with rifampin than isoni

262 All treatment-related adverse events were mild or moderate in severity and sim

263 Most adverse events were mild.

264 Adverse events and serious adverse events were minimal, but 2 deaths (7.4%) occurre

265 Systemic adverse events were more common after the second vaccina

266 Serious adverse events were more common with systematic treatmen

267 Adverse events were more common with zoledronic acid tha

268 Treatment-emergent adverse events were most frequent in the highest dose gr

269 Adverse events were mostly mild and equally distributed

270 Adverse events were mostly mild or moderate and none wer

271 The most common adverse events were neck or arm or shoulder pain, arm pa

272 The most common treatment-related grade 3-4 adverse events were neutropenia (15 [50%] of 30 patients

273 The most common any-cause grade 3 or worse adverse events were neutropenia (85 [32%] of 266 patient

274 Intraoperative and postoperative adverse events were noted.

275 Lumbar puncture-related adverse events were observed in most participants.

276 The most common grade 3-4 adverse events were raised gamma-glutamyltransferase (13

277 was well tolerated and no study drug-related adverse events were recorded.

278 No serious adverse events were related to vaccination.

279 Two serious adverse events were reported - both resolved without seq

280 Solicited adverse events were reported by 44% of vaccine recipient

281 Serious adverse events were reported for 18 (8%) patients in the

282 Adverse events were reported in 108 (69%) of 156 patient

283 Treatment-emergent adverse events were reported in 122 (53%) of 230 patient

284 Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1

285 Adverse events were reported in 58.4% of patients; most

286 Serious adverse events were reported in five (3%) of 156 patient

287 Eight serious adverse events were reported with capsular release and t

288 No severe vaccine-related adverse events were reported.

289 Serious adverse events were similar between groups (112 [43%] of

290 Cumulative rates of serious adverse events were similar in TAK-003 (4.0%) and placeb

291 Adverse events were similar in the two trial groups, wit

292 Reports of adverse events were similar to those of previous ixekizu

293 mmon (>=20% patients in any group) grade 3-4 adverse events were thrombocytopenia (33 [42%] of 78, 26

294 Serious procedure-related adverse events were uncommon.

295 ad acute grade 3 or worse treatment-emergent adverse events, which accorded with frequently reported

296 36 individuals had 63 serious adverse events, which included 25 suicide attempts and 2

297 There were no unexpected adverse events with (177)Lu-PSMA retreatment.

298 There were decreased Optimizer-related adverse events with the 2-lead system compared with the

299 ities may also affect the risk of developing adverse events with TKIs.

300 patients had grade 3 or 4 treatment-related adverse events, with the most common being weight increa