ライフサイエンスコーパス: serious adverse event

1 2.90, p = 0.6176; 1 death was reported as a serious adverse event).

2 roup had an adverse event and 63 [20%] had a serious adverse event).

3 No RCT reported any serious adverse event.

4 (8%) patients in the usual care group had a serious adverse event.

5 arthropathy in one participant was the only serious adverse event.

6 16 (2%) of 664 participants had serious adverse events.

7 icipants who had lower versus higher ARIs in serious adverse events.

8 ular disease (CVD) events but can cause some serious adverse events.

9 mortality at 90 days, and procedure-related serious adverse events.

10 t rate of TPV nonimplantation and procedural serious adverse events.

11 s (OR) for objective response rate (ORR) and serious adverse events.

12 and posttransplantation, with a low rate of serious adverse events.

13 5.0%; 95% CI, 1.6%-8.4%; P = .005), with no serious adverse events.

14 overall survival, response to treatment, and serious adverse events.

15 There were no serious adverse events.

16 ts most likely to benefit and not experience serious adverse events.

17 rectly identify absolute risk difference for serious adverse events.

18 dverse events leading to discontinuation, or serious adverse events.

19 relapsed and 2 discontinued treatment due to serious adverse events.

20 Study drugs were well tolerated with no serious adverse events.

21 and fall (n=6; 20%); four patients (13%) had serious adverse events.

22 f-care identification of persons at risk for serious adverse events.

23 s required discontinuation of therapy due to serious adverse events.

24 ences in the risk of death, cancer, or other serious adverse events.

25 t strategy, however, could be an increase in serious adverse events.

26 and PD-1 were associated with lowest risk of serious adverse events.

27 lled studies reported low rates of death and serious adverse events (0% to 1.25%) in nontransported p

28 atient-year [95% CI, 5.26 to 7.77]), as were serious adverse events (0.29 events per patient-year [95

29 t (29 [13%] of 223 vs 141 [64%] of 219) or a serious adverse event (11 [5%] of 223 vs 63 [29%] of 219

30 Respiratory failure was the most common serious adverse event (12 [8%] vs seven [5%]).

31 e); 12 discontinued (six, five, one); 24 had serious adverse events (12, nine, three).

32 treated patients had a higher rate of CV/CBV serious adverse events (13.4 per 1,000 person years [PYs

33 rse event and 71 [23%] of 312 patients had a serious adverse event; 288 [91%] of 315 patients in the

34 17 serious adverse events (3%) were reported during the stu

35 of 78 patients vs 81 [99%] of 82 patients), serious adverse events (36 [46%] vs 38 [46%]), and death

36 nal hemodialysis group; chemotherapy-related serious adverse events, 39% vs 37%, respectively; and at

37 The clinical efficacy (99.2% vs 98.8%) and serious adverse events (6.4% vs 7.5%) were similar for b

38 leading to death (eight [4%] vs four [4%]), serious adverse events (65 [29%] vs 31 [28%]), and adver

39 plus bendamustine; however, the incidence of serious adverse events (65%) and 2 deaths on study led t

40 Incident decompensation was the most common serious adverse event (7% overall).

41 Only one serious adverse event, a high temperature and refusal to

42 umber needed to harm (NNH) of 27 to induce 1 serious adverse event (absolute risk increase [ARI] = 0.

43 No deaths, serious adverse events (AEs), Grade 4 AEs or AEs leading

44 140 in the placebo group; the most frequent serious adverse events (affecting >/=2% of patients) wer

45 tients in the placebo group; the most common serious adverse events (affecting >/=2% of patients) wer

46 Serious adverse events (all grades) occurred in 91 (34%)

47 Four serious adverse events (all in the ceftazidime-avibactam

48 Eight (3%) patients (n=4 per group) reported serious adverse events; all except one event in the plac

49 was <1%, whereas the cumulative incidence of serious adverse events and musculoskeletal events was >1

50 There were no serious adverse events and no withdrawals from the study

51 infarction, and heart failure), and safety (serious adverse events and renal failure) were evaluated

52 nt difference between groups in the rates of serious adverse events and serious infections.

53 Serious adverse events and study drug discontinuations d

54 treatment costs, treatment-related risks of serious adverse events and subsequent costs, and quality

55 Overall rates of serious adverse events and treatment discontinuation wer

56 Four (33%) patients had a serious adverse event, and 12 (100%) patients had treatm

57 first adverse event, 0.32 (0.15 to 0.68) for serious adverse events, and 0.23 (0.13 to 0.41) for nons

58 ortions of patients with any adverse events, serious adverse events, and adverse events leading to di

59 Overall, reported adverse events, serious adverse events, and adverse events leading to pe

60 2330672 was generally well tolerated without serious adverse events, and demonstrated efficacy in red

61 primary safety end point was adverse events, serious adverse events, and major adverse cardiac event.

62 30 days after surgery; delirium; mortality; serious adverse events; and neurocognition.

63 idences of blood-product use, infection, and serious adverse events, as well as 28-day mortality, did

64 within 28 days after each injection, and all serious adverse events, assessed in toddlers and infants

65 verse events at 30 days or treatment-related serious adverse events at 12 months.

66 There were no treatment-emergent serious adverse events at 30 days or treatment-related s

67 The primary endpoint was the incidence of serious adverse events at 6 months.

68 Mortality and overall serious adverse events at 90 days were not significantly

69 No other serious adverse events attributable to angiotensin II we

70 loss in children and is not associated with serious adverse events attributed to its use.

71 was no significant difference in the risk of serious adverse events between chemotherapy and PD-1 (OR

72 een groups; there was no difference in other serious adverse events between the groups.

73 d no significant difference in the number of serious adverse events between the two groups (six [4%]

74 nce of large differences in risk of systemic serious adverse events between these two anti-VEGF drugs

75 Two serious adverse events (biliary colic and abdominal pain

76 Cooking-related serious adverse events (burns) were seen in 19 children;

77 The seven serious adverse events categorised as psychiatric disord

78 The model for serious adverse events chosen through elastic net regula

79 One fatal serious adverse event deemed unrelated to study treatmen

80 Overall and serious adverse events did not differ between the flecai

81 The overall rate of serious adverse events did not differ between treatment

82 tic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly betw

83 IV infusions and 208 SC injections, with no serious adverse events, dose-limiting toxicities, nor ev

84 One serious adverse event during deferred treatment (interst

85 Serious adverse events during maintenance were reported

86 Three serious adverse events-febrile neutropenia, intestinal p

87 Serious adverse events for all patients included anastom

88 lipids were associated with greater risk of serious adverse events from intensive treatment.

89 There were no serious adverse events (grade 2-4) and asexual parasites

90 There was no difference between groups in serious adverse events, grade 3 or 4 adverse events (tot

91 Five serious adverse events had occurred in four patients (13

92 12 patients reported serious adverse events; haemolysis and pyrexia were the

93 fit) and absolute increase in probability of serious adverse events (harm) for each individual from i

94 stive heart failure, or CVD death), and (ii) serious adverse events (hypotension, syncope, electrolyt

95 There was no serious adverse event in both groups.

96 The most common serious adverse event in the active surveillance group w

97 5%) and 22 (8%) patients had an on-treatment serious adverse event in the mepolizumab and placebo gro

98 Four of 73 (5.5%) patients had a serious adverse event in the placebo group, ten of 71 (1

99 The most common serious adverse event in the vascular-targeted photodyna

100 of 456 patients in the bortezomib group, and serious adverse events in 273 (59%) patients in the carf

101 y outcome as percentage of participants with serious adverse events in all participants who were inje

102 266 (84%) patients who received placebo, and serious adverse events in nine (3%), four (4%), and 16 (

103 d, were febrile neutropenia (27 [17%] of 155 serious adverse events in patients who received doxorubi

104 who received doxorubicin and 15 [12%] of 130 serious adverse events in patients who received gemcitab

105 ed in central Africa, because of the risk of serious adverse events in people with high Loa loa micro

106 ity and heart failure and absolute risks for serious adverse events in SPRINT were used to estimate t

107 cardiovascular adverse event; there were no serious adverse events in the 180-mg risankizumab group.

108 hose in the placebo group, or in the risk of serious adverse events (in 8.3% in the vaccine group and

109 g assessments of adverse event incidence and serious adverse event incidence, changes in safety labor

110 Serious adverse events included a superficial wound infe

111 Serious adverse events included grade 3 lung infection i

112 Serious adverse events included seizure (18 [5%] vs 22 [

113 44 (5.9%) of 740 patients reported serious adverse events, including 8 cases of sepsis.

114 Central Africa because of the occurrence of serious adverse events, including death, in persons with

115 Serious adverse events, including febrile neutropenia, p

116 15%), and 3 patients (8%), respectively, had serious adverse events, including two basal-cell carcino

117 we estimated the deaths prevented and excess serious adverse events incurred if the SPRINT intensive

118 deaths and heart failure cases prevented and serious adverse events incurred with intensive SBP treat

119 here was no evidence of greater incidence of serious adverse events, injuries, or falls in interventi

120 Serious adverse events irrespective of cause occurred in

121 No serious adverse events led to withdrawal from the study.

122 Seven (44%) of 16 patients had serious adverse events, most of which were related to th

123 The outcomes assessed were cumulative serious adverse events, musculoskeletal adverse events,

124 Two (1%) of 166 patients had serious adverse events; neither were considered related

125 There were no treatment-related serious adverse events, no treatment-related unsolicited

126 11 (8%) patients had serious adverse events, none of which were deemed relate

127 An FFR-related serious adverse event occurred in 2 patients (both in th

128 No serious adverse event occurred in more than one particip

129 No serious adverse events occurred during or after vector i

130 Treatment-emergent serious adverse events occurred in 103 (7%) women in the

131 Serious adverse events occurred in 11% of the patients w

132 Serious adverse events occurred in 13 (6%) participants

133 A total of 38 serious adverse events occurred in 15 patients (5 events

134 Serious adverse events occurred in 15% of the patients i

135 Serious adverse events occurred in 18 (17%) patients, wi

136 Serious adverse events occurred in 19 patients (33%) in

137 Serious adverse events occurred in 2 patients in the IFN

138 76 serious adverse events occurred in 23 of 40 patients wit

139 Serious adverse events occurred in 23.1% of the patients

140 Drug-related serious adverse events occurred in 28 (38%) of 74 patien

141 Serious adverse events occurred in 3 patients.

142 Serious adverse events occurred in 34 (22%) participants

143 Five serious adverse events occurred in 4 cases (15%), includ

144 Serious adverse events occurred in 4% of the patients wh

145 Serious adverse events occurred in 6% of patients in the

146 Serious adverse events occurred in 72 patients (34%) in

147 Serious adverse events occurred in 72 patients (8.4%), r

148 Serious adverse events occurred in 75 (19%) patients in

149 Eight serious adverse events occurred in each group.

150 12 serious adverse events occurred in six patients, includi

151 Serious adverse events occurred in ten patients (32%) an

152 Serious adverse events occurred in two (2%) patients eac

153 Treatment-related serious adverse events occurred in two patients in the i

154 Three serious adverse events occurred that were unrelated to t

155 Two unexpected serious adverse events occurred, both for the first pati

156 o episodes of serious hypoglycaemia or other serious adverse events occurred.

157 ccine was well tolerated: no vaccine-related serious adverse events occurred.

158 No serious adverse events occurred.

159 No vaccine-related serious adverse events occurred; 15 (3%) of 562 particip

160 Serious adverse events occurring in 5% or more of patien

161 Serious adverse events occurring in more than 2% of pati

162 Serious adverse events occurring in more than two patien

163 n the initial treatment phase, there was one serious adverse event of pneumonia, which led to treatme

164 hree patients in the amitriptyline group had serious adverse events of altered mood, and one patient

165 Serious adverse events of any grade occurred in 244 (43%

166 svir, and uprifosbuvir plus ribavirin due to serious adverse events of vomiting and tachycardia.

167 Eight serious adverse events (one with placebo, two with 30 mu

168 Six (3%) patients had 11 serious adverse events: one (2%) patient in the placebo

169 quartile range, 20-30 mo), no patients had a serious adverse event or relapse of vasculitis.

170 ts tolerated the regimen well; there were no serious adverse events or adverse event-related disconti

171 lesterol and safety outcomes, either for all serious adverse events or any of the other nine prespeci

172 No treatment-related serious adverse events or deaths occurred.

173 No product-related serious adverse events or deleterious immune responses o

174 There were no serious adverse events or discontinuations due to advers

175 TCH was not associated with a higher rate of serious adverse events or hospitalizations, but it was a

176 endent factors associated with the number of serious adverse events (OR 3.07 [95% CI 1.75-5.38; p=0.0

177 suggested no difference in the incidence of serious adverse events (OR, 1.00; 95% confidence interva

178 nuations occurred because of adverse events, serious adverse events, or deaths in patients who receiv

179 Only one serious adverse event (pancreatitis in the study group)

180 Three (6%) patients had treatment-related serious adverse events (pemphigoid, adrenal insufficienc

181 There was no significant excess of serious adverse events prespecified as being of special

182 Serious adverse event rates were generally stable over t

183 se events, representing 111 (39%) of all 285 serious adverse events recorded, were febrile neutropeni

184 Serious adverse events (regardless of relation to study

185 The most common serious adverse events, regardless of relationship to tr

186 No patient had a serious adverse event related to the study drug.

187 19 (8%) of 249 patients had a serious adverse event related to treatment with avelumab

188 16 (9%) of 184 patients had a serious adverse event related to treatment with avelumab

189 Fistula repair was not associated with any serious adverse events related to mesenchymal stem cells

190 of adverse events were mild in severity; no serious adverse events related to study drug and no rele

191 No serious adverse events related to tenofovir use were rep

192 local reactions occurred, and there were no serious adverse events related to the study medication.

193 Of 194 serious adverse events reported in 26 participants who h

194 30672 treatment for 14 days was safe with no serious adverse events reported.

195 ety and regulatory affairs personnel to meet serious adverse event reporting requirements.

196 The three most common serious adverse events, representing 111 (39%) of all 28

197 No serious adverse events requiring hospitalisation were re

198 o significant difference in the incidence of serious adverse events (RR: 1.02; 95% CI: 0.94 to 1.09)

199 deaths but higher rates of treatment-related serious adverse events (SAE) than patients randomized to

200 IS-related serious adverse events (SAE) were reported in 47% of pat

201 days, and 3-, 6-, and 12-months for safety (serious adverse events [SAE]), and efficacy endpoints: e

202 and bevacizumab of the incidence of systemic serious adverse events (SAEs) among patients with neovas

203 No serious adverse events (SAEs) were attributable to study

204 Serious adverse events (SAEs) were more common in CTP cl

205 for IS contraindications were predefined and serious adverse events (SAEs) were reported to ethics co

206 tissue sarcoma group) had treatment-emergent serious adverse events (SAEs), five of whom had immune-r

207 re underpowered to identify risk factors for serious adverse events (SAEs), thereby limiting their in

208 ety of FMT compared to SOC using FMT-related serious adverse events (SAEs).

209 Serious adverse events such as infection, urinary retent

210 opoietin-stimulating agents (ESAs) regarding serious adverse events, such as venous thromboembolism (

211 Serious adverse events suspected to be study drug relate

212 and no placebo recipients experienced fatal serious adverse events suspected to be study drug-relate

213 Monthly IPT-DP was associated with fewer serious adverse events than placebo, daily co-trimoxazol

214 b and 54 (20%) of 265 assigned placebo had a serious adverse event that was judged by the investigato

215 adache days, number of trial completers, and serious adverse events that emerged during treatment.

216 The most common serious adverse events that occurred through week 24 wer

217 ag recipients and two placebo recipients had serious adverse events that were suspected to be study d

218 rial data to estimate risk of CVD events and serious adverse events; the models included terms for in

219 One serious adverse event (transient atrial fibrillation) oc

220 , and factors associated with experiencing a serious adverse event using Poisson regression.

221 experienced at least one treatment-emergent serious adverse event was 16 (23%) of 70 patients in the

222 lated to sodium thiosulfate; the most common serious adverse event was decreased neutrophil count: 26

223 The most common serious adverse event was infection, most of which were

224 p, compared with the midazolam group, and no serious adverse event was observed with sevoflurane.

225 At least one serious adverse event was reported in 65 (41%) of 157 pa

226 mon adverse event was nausea and most common serious adverse event was worsening of underlying Crohn'

227 The incidence of serious adverse events was not significantly different i

228 Occurrence of adverse events and serious adverse events was similar between the treatment

229 The incidence of adverse events and serious adverse events was similar between treatment gro

230 The frequency of serious adverse events was similar in the rilotumumab an

231 The most common serious adverse events were anaemia (eight [4%]), upper

232 The most common serious adverse events were ascites (two patients in the

233 No serious adverse events were associated with receipt of i

234 No serious adverse events were attributed to GEN-003.

235 Overall adverse events and serious adverse events were balanced between the two gro

236 The most common serious adverse events were diarrhoea (69 [18%] patients

237 The most frequent serious adverse events were diarrhoea (three patients [4

238 Serious adverse events were documented and did not diffe

239 No vaccine-related serious adverse events were documented.

240 Serious adverse events were experienced by 35 (18%) pati

241 The most common serious adverse events were gastrointestinal (nausea and

242 The most common non-serious adverse events were headache and fatigue.

243 Thirteen serious adverse events were identified among recipients

244 80 serious adverse events were identified, of which two wer

245 Serious adverse events were more frequent the in G-CSF a

246 Serious adverse events were not statistically different

247 No clinically meaningful differences in serious adverse events were noted between the study grou

248 11 treatment-emergent serious adverse events were noted in seven patients (6%)

249 Neither virologic relapses nor serious adverse events were noted.

250 In this phase 1 trial, no serious adverse events were observed with inclisiran.

251 No drug-related serious adverse events were observed.

252 No serious adverse events were observed.

253 Two of 13 serious adverse events were possibly associated with TRF

254 The most common grade 3-4 adverse events or serious adverse events were postoperative neurological d

255 The most common serious adverse events were pyrexia (six [12%]), febrile

256 Serious adverse events were rare (6 patients) and were o

257 who received antitoxin had better survival; serious adverse events were rare.

258 Fourteen serious adverse events were recorded and resolved.

259 26 serious adverse events were recorded in 21 (10%) infants

260 Serious adverse events were recorded in three (3%) patie

261 Serious adverse events were reported by 2.8% (n = 3) and

262 Serious adverse events were reported by 227 (15%) of 150

263 Serious adverse events were reported by seven (2%), six

264 Nine serious adverse events were reported by seven (4%) of 15

265 Four serious adverse events were reported during the conduct

266 Eight serious adverse events were reported during the course o

267 Serious adverse events were reported in 102 (25%) of 403

268 Serious adverse events were reported in 13 (13%) of 103

269 Serious adverse events were reported in 13 patients (11%

270 Treatment-related serious adverse events were reported in 133 (37%) patien

271 Serious adverse events were reported in 134 (23%) of 573

272 Serious adverse events were reported in 145 (46%) of 313

273 Serious adverse events were reported in 155 (49%) versus

274 Serious adverse events were reported in 17 (28%) of 61 p

275 Serious adverse events were reported in 17 (8%) patients

276 Serious adverse events were reported in 20 (22%) patient

277 Treatment-related serious adverse events were reported in 21 (9%) patients

278 Serious adverse events were reported in 24% of the patie

279 Serious adverse events were reported in 49 (43%) of 115

280 Serious adverse events were reported in 56 (58%) eltromb

281 Serious adverse events were reported in 60.7% of the pat

282 Serious adverse events were reported in 64 (22%) of 288

283 Serious adverse events were reported in four (5%) patien

284 11 serious adverse events were reported in seven (25%) pati

285 No severe or serious adverse events were reported in the BIIB074 grou

286 0 (32%) of 156 in the placebo group, and 181 serious adverse events were reported in total, 95 (52%)

287 Three serious adverse events were reported, all in patients in

288 16 serious adverse events were reported, including one fata

289 in severity, and no severe adverse events or serious adverse events were reported.

290 No serious adverse events were reported.

291 reatment was associated with fatigue, but no serious adverse events were reported.

292 Serious adverse events were similar across arms, althoug

293 Serious adverse events were similar and low in all group

294 Treatment-related serious adverse events were similar between groups (13 [

295 ejection (5.7% vs 7.9%), adverse events, and serious adverse events were similar with TacHexal or Pro

296 sthma control without increasing the risk of serious adverse events when compared with optimised usua

297 l adhesions with obstruction as a severe and serious adverse event, which was considered as unrelated

298 pancreatoduodenectomy group had at least one serious adverse event, with the most common being reoper

299 Serious adverse events within 12 months after injection

300 s are the incidence of study product-related serious adverse events within 180 days, grade 3 solicite