ライフサイエンスコーパス: phase @1 trial

1 ractory AML (rrAML) patients with mIDH2 in a phase 1 trial.

2 600E)-positive papillary thyroid cancer in a phase 1 trial.

3 inical activity will require validation in a phase 2 trial.

4 nduction therapy for ulcerative colitis in a phase 2 trial.

5 agent ibrutinib on an investigator-initiated phase 2 trial.

6 These findings warrant a phase 3 trial.

7 d within the multicenter African RTS,S/AS01E phase 3 trial.

8 were tested in phase 2 trials preceding the phase 3 trial.

9 rial do not support continuation to a larger phase 3 trial.

10 e, in men with low-risk prostate cancer in a phase 3 trial.

11 ia enrolled in an open-label, non-randomised phase 3 trial.

12 e double-blind randomized placebo-controlled phase 3 trial.

13 ficacy and safety analyses from a subsequent phase 3 trial.

14 f eculizumab in this patient population in a phase 3 trial.

15 enicity of RG7787 is now being assessed in a phase I trial.

16 homa) and A051202 (follicular lymphoma) were phase 1 trials.

17 advanced solid tumours in a dose-escalation phase 1a trial.

18 PMBCL as part of the KEYNOTE-013 multicohort phase 1b trial.

19 against GI cancers and is currently awaiting Phase 2 trials.

20 dy to CD25, has shown encouraging results in phase 2 trials.

21 ilteritinib at 120 mg/day is being tested in phase 3 trials.

22 sis and pulmonary embolism has been shown in phase 3 trials.

23 , this new vaccine is under investigation in phase 3 trials.

24 sites to pilot the roll-out of RTS,S/AS01 in phase 4 trials.

25 ponses in two subjects that were part of the phase II trial.

26 -arm, single-stage, open-label, multicenter, phase II trial.

27 s evaluated in 43 patients in a prospective, phase II trial.

28 to assess the benefit of MDT in a randomized phase II trial.

29 mismatched Gag immunogens in the TamoVac 01 phase IIa trial.

30 inating event to clinically definite MS in a phase III trial.

31 ently randomized stratified subgroup of this phase III trial.

32 t vaccine Butantan-DV, which is currently in phase III trials.

33 finitions were chosen in accordance with the Phase III trials.

34 sentative of the participating sites in both Phase III trials.

35 s) of action and enhance planning of pivotal Phase III trials.

36 sting that MDT should be explored further in phase III trials.

37 umerous therapies that are currently in late-phase clinical trials.

38 nt in pro-cognitive drug discovery and early-phase clinical trials.

39 therapeutic in preclinical studies and early-phase clinical trials.

40 ul in monitoring treatment response in early phase clinical trials.

41 ed 67 heavily pretreated patients on 3 early phase clinical trials.

42 this prospective, international, multicenter phase II trial, 152 treatment-naive adult solid organ tr

43 and Methods In this multicenter, open-label, phase III trial, 2,012 women with early TOP2A-normal bre

44 In this randomised, open-label, multicentre, phase 2 trial, 29 academic medical centres in the USA as

45 nd Methods In this prospective, neoadjuvant, phase II trial, 375 patients with early breast cancer wi

46 In this multicenter phase 2 trial, 72 patients were randomized to receive 24

47 b monotherapy in clinical studies, including phase III trials; 86 (10%) had mucosal melanoma and 665

48 Large Phase III trials across Asia and Latin America have rece

49 In this randomised, controlled, phase 3 trial, adult patients (aged 18 years or older) f

50 In this single-arm phase 2 trial, adults with laboratory-confirmed EVD rece

51 afety data from a single-centre, open-label, phase 2 trial, after a median of 83 months follow up.

52 Minnelide has just completed Phase 1 trial against GI cancers and is currently awaiti

53 In this multicentre, randomised, open-label phase 3 trial (AGATE-I), treatment-naive and interferon

54 data for 333 patients from Myeloma XI, a UK phase 3 trial and 434 patients from the CoMMpass study,

55 Encouragingly, randomized phase 3 trials are assessing novel agents, including bre

56 eeks as the dose for further development and phase 3 trials are ongoing.

57 We report results of the first phase 3 trial assessing long-acting intramuscular pasire

58 d this interim analysis of a non-randomised, phase 2 trial at 20 hospitals in the UK.

59 andomised, single-blind, placebo-controlled, phase 2 trial at 25 sites in Australia, Poland, and Spai

60 We did a prospective, single-group, phase 2 trial at 28 hospitals in France, with patients r

61 We did this single-arm, multicentre, phase 2 trial at ten academic centres in the USA.

62 We did a phase 2 trial at the University of Texas MD Anderson Can

63 We did a single-arm, phase 2 trial at two academic hospitals in the USA, enro

64 We did two single-arm phase 2 trials at six centres in the USA and Poland.

65 ouble-blind, randomised, placebo-controlled, phase 2a trial at ten sites in the USA.

66 andomised, double-blind, placebo-controlled, phase 3 trial at 54 sites in 18 countries located in Nor

67 ouble-blind, randomised, placebo-controlled, phase 3 trial at 75 centres in the USA and Europe.

68 In a phase 1 trial, axicabtagene ciloleucel (axi-cel), an aut

69 There are only 2 phase III trials, both on remote ischemic conditioning i

70 R3 that has shown promising results in early-phase clinical trials, but an optimal target population

71 Some are making the transition into early-phase patient trials, but the lack of validated biomarke

72 specimens collected as part of the Alliance phase III trial, C9581.

73 okinetic and pharmacodynamic substudy from 4 phase 2 trials, circulating PCSK9 levels were measured a

74 12 months in the immunogenicity subsets of 2 phase 3 trials (clinical trials registration NCT01373281

75 To improve this figure, several early phase clinical trials combining novel immunotherapeutics

76 The EORTC 18071 phase 3 trial compared adjuvant ipilimumab with placebo

77 and Methods This randomized (1:1) open-label phase II trial compared the efficacy of pazopanib 800 mg

78 This randomized phase III trial compared lenalidomide as maintenance the

79 On the basis of these results, we did a phase 2 trial comparing bictegravir with dolutegravir.

80 Cytomegalovirus genotyping results from a phase 2 trial comparing brincidofovir to placebo for pro

81 We report a phase 3 trial comparing the benefit-risk profile of ipil

82 Phase III trials comparing non-vitamin K antagonist oral

83 randomised, double-blind, placebo-controlled phase 2b trial, comprised of 6-month run-in, 9-month tre

84 Transplant Clinical Trials Network (BMT CTN) phase 2 trial conducted from 2008 to 2014 enrolled 30 ch

85 randomized double-blind, placebo-controlled phase 3 trial conducted at National Cancer Centre Singap

86 Data from 8 Phase 3 trials conducted with background statin (n = 462

87 om 22,654 patients enrolled in 28 randomized phase III trials contained in the ARCAD (Aide et Recherc

88 andomised, double-blind, placebo-controlled, phase 3 trial (CONTINUUM) was done at 111 hospitals, med

89 lish safety in ARDS are in progress, and two phase 1 trials did not report any serious adverse events

90 The findings of this phase 2b trial do not support continuation to a larger p

91 This was an open-label, dose-escalation phase 1 trial done at two study sites in Japan.

92 s an international, multicentre, single-arm, phase 2 trial done at 29 centres in eight European count

93 In this open-label, multicentre, phase 2 trial done in Canada, Spain, and the USA, patien

94 MINE was a double-blind, placebo-controlled, phase 2b trial done at 105 study centres across 19 count

95 is randomised, double-blind, parallel-group, phase 3 trial done at 152 sites in 21 countries, adults

96 In this open-label, randomised, controlled phase 3 trial done at two sites in the USA, individuals

97 The GeDDiS trial was a randomised controlled phase 3 trial done in 24 UK hospitals and one Swiss Grou

98 andomised, double-blind, placebo-controlled, phase 3 trial done in 97 centres in 25 countries worldwi

99 bicentre, open-label, randomised, three-arm phase 3 trial done in Lisungi health centre in DR Congo,

100 SIRFLOX, and FOXFIRE-Global were randomised, phase 3 trials done in hospitals and specialist liver ce

101 o similar, double-blind, randomized, 6-month phase 3 trials (Elaris Endometriosis I and II [EM-I and

102 andomised, double-blind, placebo-controlled, phase 3 trial, eligible women aged 18 years or older (>/

103 ght in patients with advanced melanoma, this phase 3 trial evaluated ipilimumab at a dose of 10 mg pe

104 ouble-blind, randomised, placebo-controlled, phase 3 trial evaluated olaparib tablet maintenance trea

105 Purpose This phase I trial evaluated epigenetic modulation of vascula

106 This phase II trial evaluated whether complete clinical respo

107 We report the results of a phase 2 trial evaluating ibrutinib in recurrent FL.

108 GELA designed a randomized phase 2 trial evaluating the efficacy of either rituxima

109 Early-phase clinical trials evaluating CD8(+) T cell-eliciting

110 A phase 1 trial followed by a phase 2 efficacy trial was c

111 Phase 2 trials for (18)F-TFB as an hNIS imaging agent ar

112 uat (compound 24, BAY 1021189), currently in phase 3 trials for chronic heart failure, are now report

113 foundation for more than 50 active advanced-phase clinical trials for AD prevention and therapy.

114 ral solid tumor types, and the initiation of phase I trials for A2AR antagonists in oncology, this ap

115 nd other neurodegenerative disorders, with a phase II trial for RP under way.

116 valproic acid (VPA), currently undergoing a phase II trial for RP, has both beneficial and detriment

117 e clinical solution to challenges arising in phase I trials from the dose-dependent side effects of t

118 his ongoing, placebo-controlled, randomised, phase 3 trial, had metastatic or unresectable disease, E

119 duration of tuberculosis treatment in costly phase 3 trials has raised serious questions about the re

120 t exploratory subgroup analyses of the large phase 3 trials have demonstrated that patients with chro

121 pectrum of HF, preliminary results from many phase II trials have been promising but are frequently f

122 mor, and only four randomized trials and one phase III trial have been completed so far, all in the f

123 randomised, double-blind, placebo-controlled phase 2 trial, healthy adults aged 18-31 years were rand

124 andomised, double-blind, placebo-controlled, phase 3 trial if they had symptomatic disease requiring

125 We conducted a multicenter phase 1 trial in 34 patients to establish the maximum to

126 Pilot data in a phase 2 trial in non-ST elevation MI indicated that the

127 andomised, double-blind, placebo-controlled, phase 2 trial in patients with the basal-cell nevus (Gor

128 domized, parallel, single-blind dose-ranging phase 2 trial in the Lao People's Democratic Republic in

129 earranged lung cancers, we did a prospective phase 2 trial in this molecular subgroup.

130 on concealed, randomised, placebo-controlled phase 2 trial in two intensive care units in the UK, inv

131 e, placebo-controlled, randomised withdrawal phase 2a trial in 25 secondary care centres in Denmark,

132 We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic ur

133 CheckMate 141 was a randomised, open-label, phase 3 trial in patients with recurrent or metastatic s

134 s a multinational, double-blind, randomised, phase 3 trial in patients with stage III cutaneous melan

135 s measured among participants in traditional phase 3 trials in high-incidence settings and then apply

136 Ruxolitinib is in late-phase clinical trials in essential thrombocythemia, in w

137 METHODS AND A randomised, open-label phase I trial in Lambarene, Gabon, studied 5 single intr

138 A phase I trial in patients with NHL was conducted to dete

139 changes in this single-season, dose-finding, phase IIb trial in patients allergic to birch pollen.

140 thout a leukotriene receptor antagonist in a phase III trial in adolescent patients with moderate sym

141 same domains that had at least one completed phase III trial in the same time frame, but failed to re

142 Methods This randomized, double-blind, phase III trial included AI-treated postmenopausal women

143 icentre, open-label, randomised, controlled, phase 3 trial, included postmenopausal patients with ear

144 randomised, double-blind, active-controlled, phase 4 trial (INTREPID, we recruited adults aged 18-70

145 In a phase 3 trial involving 299 patients who were younger th

146 ive response rate than ipilimumab alone in a phase 3 trial involving patients with advanced melanoma.

147 We conducted two phase 3 trials involving patients who had been previousl

148 were no new safety signals; investigation in phase 3 trials is encouraged.

149 which has progressed into healthy volunteer Phase 1 trials, making it the "first-in-class" small-mol

150 this randomised, open-label, international, phase 3 trial, men with radiographically documented meta

151 om smaller individual postoperative adjuvant phase 3 trials, meta-analyses, retrospective analyses, r

152 andomised, double-blind, placebo-controlled, phase 3 trial (METOP) at 16 sites in Germany, France, th

153 ebo-controlled, parallel-group, multicentre, phase 3b trial (MUSCA) in 146 hospitals or research cent

154 In this phase 1 trial, no serious adverse events were observed w

155 We did a randomised, open-label, phase 3 trial (OAK) in 194 academic or community oncolog

156 A phase 1 trial of 45 children and young adults with relap

157 A recent phase 1 trial of the fatty acid amide hydrolase (FAAH) i

158 We present the final results of two phase 1 trials of an attenuated, replication-competent,

159 s and Relevance: In this meta-analysis, most phase 1 trials of targeted agents did not use a biomarke

160 atin, and docetaxel) trial is a prospective, phase 2 trial of 252 patients with resectable or metasta

161 did a randomised, double-blind, multicentre phase 2 trial of a combination of oseltamivir, amantadin

162 ective, multicentre, randomised, open-label, phase 2 trial of adult patients (aged >18 years) with ad

163 A randomised phase 2 trial of alternative dosing strategies of this c

164 Single-center, single-arm, open-label phase 2 trial of CombiDT treatment in patients with BRAF

165 o our knowledge, this is the first completed phase 2 trial of immunotherapy for SCCA.

166 The I-SPY 2 trial, a multicenter, adaptive phase 2 trial of neoadjuvant therapy for high-risk clini

167 A post hoc analysis was performed of the phase 2 trial of NP001 to determine whether stratificati

168 Moreover, a post hoc analysis of the phase 2 trial of NP001 using the same CRP threshold show

169 a 12-week, double-blind, placebo-controlled, phase 2 trial of patients with alkaline phosphatase of a

170 MAJIC is a randomized phase 2 trial of ruxolitinib (JAK1/2 inhibitor) vs best

171 We did a phase 2 trial of ruxolitinib to test this hypothesis.

172 We performed a phase 2 trial of the efficacy and safety of 4, 6, and 8

173 A randomized, placebo-controlled phase 2 trial of two vaccines that was rapidly initiated

174 In a phase 2a trial of patients with moderate to severe Crohn

175 We did an open-label, randomised, phase 3 trial of adult patients (aged >/=18 years) with

176 l of 891 patients with advanced HNSCC from a phase 3 trial of cisplatin plus radiotherapy with or wit

177 ctive, randomized, double-blind, multicenter phase 3 trial of intention-to-treat (full analysis set),

178 ive probability of success in a confirmatory phase 3 trial of neoadjuvant therapy reached a prespecif

179 In a phase 3 trial of patients with Crohn's disease and treat

180 in 215 patients with CBF-AML enrolled in the Phase 3 Trial of Systematic Versus Response-adapted Time

181 initiated a randomized, placebo-controlled, phase 3 trial of the chimpanzee adenovirus 3 vaccine (Ch

182 h 7 additional placebo and active-comparator phase 3 trials of duloxetine (n = 2515).

183 Pooled, retrospective analysis of data from phase 3 trials of nivolumab in treatment-naive patients

184 In phase 3 trials of patients with HCV infection, we did no

185 t populations of the three global randomised phase 3 trials of pirfenidone versus placebo-Clinical St

186 in the first 5 participants enrolled in this phase I trial of virus-based gene transfer in this mitoc

187 -hydroxycamptothecin (SN-38), in an expanded phase II trial of patients with relapsed or refractory m

188 ernational, open-label randomized controlled phase III trial of adjuvant combination chemotherapy com

189 and target population were identified for a phase III trial of IMGN853 monotherapy in patients with

190 ction adenocarcinoma, Intergroup Trial 0116 (Phase III trial of postoperative adjuvant radiochemother

191 or more controller medications, in the first phase III trial of tiotropium in children with severe sy

192 logy of dengue viruses (DENV) in two pivotal phase III trials of the tetravalent dengue vaccine, CYD-

193 In this open-label, non-randomised, phase 2 trial, patients aged 18-55 years, who were treat

194 andomised, double-blind, placebo-controlled, phase 2 trial, patients aged 18-60 years with 4 to 14 mi

195 d Methods In this multicenter, double-blind, phase III trial, patients were randomly assigned (2:1) t

196 This international, multicentre, randomised, phase 3 trial (PERSIST-1) was done at 67 sites in 12 cou

197 agents or combinations (70%) were tested in phase 2 trials preceding the phase 3 trial.

198 b on lymphocyte subsets collected during the phase 3 trial program reveal mechanisms explaining effic

199 This open-label, first-in-man, phase 1 trial recruited adult patients (aged >/=18 years

200 basis of preclinical evidence and a previous phase I trial, respectively.

201 These phase 3 trial results point to little benefit to current

202 In this phase 2 trial, selective blockade of interleukin-23 with

203 A previous phase 1 trial showed pyrimethamine lowers SOD1 levels in

204 In a phase 1 trial, single-dose O6-benzylguanine with topical

205 This phase 1b trial studied patients with relapsed/refractory

206 A phase 2 trial suggested increased overall survival and i

207 Data from a phase 2 trial suggested that the addition of bevacizumab

208 Phase 3 trials suggested similar clinical responses and

209 e supported by preclinical studies and early-phase clinical trials suggesting that these approaches m

210 lel-group, international, placebo-controlled phase 3a trial (SUSTAIN 1) at 72 sites in Canada, Italy,

211 parallel-group, multicentre, multinational, phase 3a trial (SUSTAIN 4) at 196 sites in 14 countries.

212 multicentre, randomised, placebo-controlled, phase 3 trial (TACE 2) in 20 hospitals in the UK for pat

213 We report results from a phase 1 trial testing a new CD22-targeted CAR (CD22-CAR)

214 On the basis of data from a phase 2 trial that compared the checkpoint inhibitor ipi

215 MISTIE was an open-label, phase 2 trial that was done in 26 hospitals in the USA,

216 1 was a multicentre, randomised, open-label, phase 3 trial that enrolled participants at 38 participa

217 ropose a recommended schema for a randomised phase 3 trial that might potentially answer this questio

218 years, more than 11571 patients enrolled in phase 3 trials that did not meet the primary end point c

219 pective, multicenter, open-label, randomized phase III trial that compared a busulfan-based RIC with

220 se end points in five prospective randomized phase III trials that enrolled a total of 6,081 patients

221 At the 2 x 10(7) PFU dose (used in phase 3 trials), the most common local adverse events ve

222 In a phase 2 trial, the use of CSL830, a nanofiltered C1 inhi

223 In another phase III trial, the oral combination of netupitant and

224 In one phase III trial, the oral combination of netupitant and

225 INTERPRETATION: In two phase 3 trials, tildrakizumab 200 mg and 100 mg were eff

226 of the nuclear export protein XPO1, in this phase 1 trial to assess safety and determine a recommend

227 We performed a 12-patient, 6-month, phase 1 trial to determine whether autologous mesenchyma

228 We performed a randomized, controlled phase 2 trial to assess the ability of budesonide oral s

229 ndomized, double-masked, placebo-controlled, phase 2b trial to compare the efficacy cross-sectionally

230 We did a phase 3 trial to assess a neoadjuvant regimen for HER2-p

231 We conducted a phase 3 trial to determine whether the addition of midos

232 ble-blind, placebo-controlled, dose-ranging, phase 3 trial to evaluate the efficacy and safety of sel

233 We conducted a multicenter, open-label, phase 3 trial to evaluate the efficacy and safety of tre

234 RISER trial (Adjuvant Rencarex Immunotherapy Phase 3 Trial to Study Efficacy in Nonmetastatic RCC) wa

235 We did two phase 3 trials to investigate whether tildrakizumab is s

236 We designed a Phase II trial to assess whether a neurocritical care ma

237 address this point, we designed a randomized phase III trial to compare rituximab plus cyclophosphami

238 We report a prospective, double-blind phase III trial to investigate the effect of ATLG (Neovi

239 Patients and Methods In this single-center phase II trial, treatment-naive patients received everol

240 Post hoc analysis of 2 similarly designed phase 3 trials, VISTA and VIVID.

241 sis of a subgroup of laser control eyes in 2 phase 3 trials-VISTA (Study of Intravitreal Aflibercept

242 The objective of this first-in-patient phase 1b trial was to evaluate the safety/tolerability a

243 uble-blinded, randomised, placebo-controlled phase 2 trial was conducted in four UK medical centres t

244 andomised, double-blind, placebo-controlled, phase 2 trial was done in 34 centres in 11 countries.

245 ticentre, open-label, randomised, controlled phase 2 trial was done in three UK hospitals and recruit

246 This randomised, double-blind, multiperiod, phase 3 trial was done at 38 clinics in 13 countries.

247 This randomised, double-blind, multicentre, phase 3 trial was done in 87 centres in 21 countries wor

248 The primary end point of this randomized phase 3 trial was not achieved.

249 This multicenter, open-label, randomized phase 3 trial was undertaken by Dutch-Belgium Cooperativ

250 A Fleming phase II trial was designed.

251 ng results in phase II studies, a randomized phase III trial was designed to assess the efficacy of a

252 double-blind, randomized placebo-controlled phase 1 trial, we evaluated the safety and complement in

253 In this phase 1 trial, we randomly assigned healthy volunteers w

254 s single-centre, open-label, dose-escalation phase 1 trial, we recruited adult patients (aged >/=18 y

255 In this multicentre phase 1b trial, we recruited patients aged 18 years or o

256 In this open-label, phase 1b trial, we recruited patients from 12 medical ce

257 In this phase 2 trial, we assessed the safety and efficacy of po

258 ouble-blind, randomized, placebo-controlled, phase 2 trial, we assigned patients to receive low-dose

259 In this multicenter, phase 2 trial, we enrolled 111 patients with diffuse lar

260 andomised, regimen-controlled, double-blind, phase 2 trial, we enrolled adult patients with multiple

261 In this ongoing, multicentre, open-label, phase 2 trial, we enrolled adults (aged >/=18 years) wit

262 f a multicentre, open-label, non-randomised, phase 2 trial, we enrolled patients aged 18 years or old

263 s non-randomised, open-label, single-centre, phase 2 trial, we enrolled patients aged 3-21 years who

264 n this open-label, single group, multicentre phase 2 trial, we recruited HIV-negative adults with de

265 In this randomised, double-blind, phase 2 trial, we recruited patients aged 45-85 years wi

266 In this randomised, double-blind, phase 2 trial, we recruited previously untreated adults

267 In the 24-month MS-STAT phase 2 trial, we showed that high-dose simvastatin sign

268 In an open-label phase 3 trial, we compared first-line nivolumab with che

269 s global, open-label, randomised, controlled phase 3 trial, we enrolled patients with relapsed CLL pr

270 multicenter, randomized, placebo-controlled, phase 3 trial, we evaluated the efficacy and safety of l

271 andomized, placebo-controlled, double-blind, phase 3 trial, we randomly assigned 395 patients, in a 2

272 In this phase 3 trial, we randomly assigned 498 patients with re

273 In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 722 patients who had

274 In this phase 3 trial, we randomly assigned 732 patients with pr

275 In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 870 patients with co

276 In this multi-institutional phase 3 trial, we randomly assigned adults with heavily

277 s multicenter, double-blind, parallel-group, phase 3 trial, we randomly assigned participants with re

278 three-arm, double-blind, placebo-controlled phase 3 trial, we randomly assigned patients aged 18 yea

279 d, active-controlled and placebo-controlled, phase 3 trial, we randomly assigned patients in a 2:2:2:

280 In this phase 3 trial, we randomly assigned patients with chroni

281 nal, randomised, double-blind, double-dummy, phase 3 trial, we recruited patients aged 16 years or ol

282 In this randomised, double-blind, phase 3 trial, we recruited patients aged 18 years and o

283 andomised, double-blind, placebo-controlled, phase 3 trial, we recruited patients aged 18-75 years, w

284 In this randomised, controlled, open-label, phase 3 trial, we recruited patients aged at least 18 ye

285 In this randomised, controlled, phase 3 trial, we recruited patients at a single tertiar

286 In this multicentre, open-label, randomised, phase 3 trial, we recruited patients from 87 academic in

287 andomised, double-blind, placebo-controlled, phase 3 trial, we recruited patients from 87 hospitals a

288 In this randomised, controlled, open-label, phase 3 trial, we recruited patients with metastatic, pe

289 In this randomised, open-label, phase 3 trial, we recruited patients with newly diagnose

290 ntre, international, randomised, open-label, phase 3 trial, we recruited patients with treatment-naiv

291 In two identical phase 3 trials, we randomly assigned 821 and 835 patient

292 In this randomised, double-blind, phase 3b trial, we enrolled adults aged 18-65 years with

293 masked endpoint, randomised, non-inferiority phase 3b trial, we recruited patients aged 18 years or o

294 In this open-label phase III trial, we evaluated the safety, tolerability,

295 Seven published phase III trials were examined for prespecified design a

296 gression, and death obtained from randomized phase III trials were used to determine the likelihood o

297 upport the validation of these approaches in phase 2 trials, which would be a catalyst for active eng

298 andomised, double-blind, placebo-controlled, phase 4 trial, with patients recruited from 176 hospital

299 were pooled from four studies, including two phase III trials, with patients who received nivolumab 3

300 andomised, placebo-controlled, double-blind, phase 2 trial, women aged 18 years or older with measura