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1 of several studies (including two randomized phase III trials).
2 with acceptable safety and tolerability in a phase 1 trial.
3 al blood of patients receiving NKTR-214 in a phase 1 trial.
4 efit, which requires further assessment in a phase 2 trial.
5 with PCa were prospectively enrolled in this phase 2 trial.
6 bstudy of a double-blind, placebo-controlled phase 2 trial.
7 ptoms with an acceptable safety profile in a phase 2 trial.
8 andomized, double-blind, placebo-controlled, phase 2 trial.
9 double-blind, randomised, placebo-controlled phase 3 trial.
10 bicin as second-line therapy in a randomised phase 3 trial.
11 ompared with standard-of-care sorafenib in a phase 3 trial.
12 icentre, open-label, randomised, controlled, phase 3 trial.
13 s was a randomized, controlled, double-blind phase 3 trial.
14 sociated variants (RAVs) among subjects in a Phase 3 trial.
15 entre, double-blind, randomised, controlled, phase 3 trial.
16 Randomized, controlled, double-blind, phase 3 trial.
17 further investigation in a large multicenter phase 3 trial.
18 m patients who participated in the Short-HER phase 3 trial.
19 e systemic dose range considered safe in the Phase I trial.
20 e-blind, placebo-controlled, dose-escalation Phase I trial.
21 showed clinical activity and tolerability in phase 1 trials.
22 ng results in patients with high-risk AML in phase 2 trials.
23 th moderate-to-severe atopic dermatitis in a phase 2b trial.
24 eld with an emphasis on drugs in Phase 2 and Phase 3 trials.
25 ed liposomal ciprofloxacin (ARD-3150) in two phase 3 trials.
26 cal trials, and 1.00 (95% CI = 0.95-1.06) in phase 3 trials.
27 ulvestrant warrants further investigation in phase 3 trials.
28 recurring pancreatic cancer in a prospective phase II trial.
29 ients enrolled in our investigator-initiated phase II trial.
30 90)Y-DOTATOC in the setting of a prospective phase II trial.
31 ebo in a double-blinded, placebo-controlled, phase IIb trial.
32 bo, in a double-blinded, placebo-controlled, phase IIb trial.
33 lase for Intracerebral Hemorrhage Evacuation Phase III trial.
34 This was a randomized, open-label, phase III trial.
35 ntrolled series, although was not in a small phase III trial.
36 t with the results coming from past clinical phase IIa trials.
37 overall survival (OS) benefit in randomized phase III trials.
38 ble formulation for HIV PrEP being tested in Phase III trials.
39 new agents are currently being evaluated in phase III trials.
40 vaccine candidates, and many have moved into phase III trials.
41 ce this combinatorial treatment toward early-phase human trials.
42 hibitors are currently being tested in early phase clinical trials.
43 ing therapeutic candidate currently in early-phase clinical trials.
44 dings into improved patient outcomes in late-phase clinical trials.
45 previously reported primary analysis of this phase 3 trial, 12 months of adjuvant dabrafenib plus tra
47 In this double-blind, placebo-controlled, phase 2 trial, 140 patients with noncirrhotic NASH, diag
48 irst stage of this adaptive, non-comparative phase 2 trial, 67 patients with metastatic TNBC were ran
51 ive probability of success in a hypothetical phase III trial, adjusting for biomarker covariates.
54 asone (KRd), has shown promising efficacy in phase 2 trials and might improve outcomes compared with
55 s Perspectives, we highlight key elements of phase I trials and discuss how each one of them contribu
56 of efficacy between proof-of-concept (i.e., Phase II trials) and pivotal, confirmatory (Phase III tr
58 cell trophic factor BAFF, was ineffective in phase III trials, and efgartigimod, which depletes antib
65 o-controlled, parallel-group, registrational phase 2 trial at 11 institutions in the United States, E
66 double-blind, randomised, placebo-controlled phase 2 trial at 70 centres in Australia, Belgium, Canad
71 s randomised, active-controlled, open-label, phase 3 trial at 16 clinical sites, we enrolled children
72 label, sponsor-blind, randomised, controlled phase 3 trial at 209 cancer treatment centres in 23 coun
73 We did an open-label randomised controlled phase 3 trial at 32 head and neck treatment centres in I
79 data from 3 Indonesian randomized controlled phase 2 trials comparing oral rifampicin 450 mg (~10 mg/
80 Here, we report results of IMmotion151, a phase 3 trial comparing atezolizumab plus bevacizumab ve
81 andomised, double-blind, placebo-controlled, phase 3 trial comparing dabrafenib 150 mg orally twice d
82 ucted a multicenter, randomized, open-label, phase 3 trial comparing the efficacy and safety of oral
84 ntrolled, observer-blinded, dose-escalation, phase 1 trial conducted in the United States, we randoml
85 novel drug targets, interpretation of early-phase clinical trial data, and development of predictive
90 This study was an open-label, single-arm, phase 2 trial done at 38 clinics or hospitals in France,
92 was an open-label, single-arm, three-cohort phase 2 trial done at the National Cancer Institute (Bet
93 double-blind, randomised, placebo-controlled phase 2a trial done at eight sites in Brazil, Malawi, So
94 s an international, multicentre, randomised, phase 3 trial done across 117 hospitals in the UK, Austr
95 en-label, active-controlled, parallel-group, phase 3 trial done at 111 academic and community practic
96 andomised, double-blind, placebo-controlled, phase 3 trial done at 147 hospitals in 36 countries.
97 ouble-blind, randomised, placebo-controlled, phase 3 trial done at 182 study locations including acad
99 andomised, double-blind, placebo-controlled, phase 3 trial done at 92 hospitals, clinics, and medical
100 KEYNOTE-185 was a randomised, open-label, phase 3 trial done at 95 medical centres across 15 count
101 s was a randomised, open-label, multicentre, phase 3 trial done at ten centres in Canada and one in A
102 our knowledge, REACH-2 is the first positive phase 3 trial done in a biomarker-selected patient popul
103 andomised, double-blind, placebo-controlled, phase 3b trial done at 64 sites (hospitals, clinics, or
104 HD was an open-label, randomised, controlled phase 4 trial done at Massachusetts General Hospital.
105 el, multicentre, parallel-group, randomised, phase 3 trial (done in 130 UK hospitals) in which postme
106 2503) is an ongoing multicentre, two-cohort, phase 3 trial, done at 108 centres in 22 countries.
107 andomised, placebo-controlled, double-blind, phase 3 trial, done in 209 sites in 29 countries, we ran
108 andomised, placebo-controlled, double-blind, phase 3 trial, done in 246 academic centres and communit
109 vir (DRV+r) and efavirenz (EFV) in 2 ongoing phase 3 trials: DRIVE-FORWARD (NCT02275780) and DRIVE-AH
111 ind, randomized, placebo-controlled, 6-month phase 3 trials (Elaris Uterine Fibroids 1 and 2 [UF-1 an
115 tional, multicentre, randomised, controlled, phase 3 trial evaluating tumour bed boost and hypofracti
117 c approach has been validated in randomised, phase 3 trials, evaluation of response to neoadjuvant ch
118 en-label, investigator-initiated, randomised phase 2 trial following a selection (or pick-the-winner)
119 esmetirom (MGL-3196), which are currently in phase 3 trials for the treatment of NASH, are reviewed.
123 es for glioblastoma multiforme (GBM) in late-phase clinical trials has directed interest toward adopt
124 linical models of neonatal brain injury, and phase 2 trials have suggested possible efficacy; however
127 y and preliminary activity results from this phase 1 trial in all patients with HER2-positive advance
128 andomised, double-blind, placebo-controlled, phase 2 trial in 20 German academic medical centres.
130 , non-randomised, single-arm, single centre, phase 2 trial in patients aged 18 years or older with HE
131 We did a multicentre, single-arm, two-stage, phase 2 trial in patients with advanced Ewing sarcoma or
132 ouble-blind, randomised, placebo-controlled, phase 2 trial in patients with decompensated cirrhosis a
133 randomized, double-blind, placebo-controlled phase 3 trial in 1154 preterm infants of 1 or 2 doses of
135 an open-label, randomised, non-inferiority, phase 3 trial in 31 transplantation centres in France, G
137 BE is an open-label, randomised, controlled, phase 3 trial in patients with untreated, unresectable,
138 mTOR, are currently being evaluated in early phase clinical trials in children with high-risk MYCN-dr
140 dy was a multicenter, open-label, multi-arm, phase II trial in patients with PI3K pathway-activated g
141 This is a French multicenter randomized phase II trial in patients with resectable high-risk T3,
142 o-to-one randomized, controlled, open-label, phase II trial in patients with untreated RAS wild-type
143 se-developed biologics, have been studied in phase II trials in patients with EoE; and (3) novel diet
146 dary outcomes in clinical trials, an ongoing phase III trial in patients with diabetic kidney disease
148 odium falciparum malaria infection completed phase III trials in 2014 and demonstrated efficacy again
153 cytokine trap, were studied previously in a phase 2 trial involving patients with recurrent pericard
155 ed an open-label, international, randomized, phase 3 trial involving patients younger than 18 years o
156 in cancer, including data from several late-phase clinical trials involving FRalpha-targeted therapi
157 activity with low toxicity in a prospective phase II trial involving 30 men with metastatic castrati
158 ducted a post hoc analysis of the vandetanib phase III trial involving patients with advanced medulla
159 randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) at Beth Israel Deacone
160 duced MRI activity in a phase 2 trial, and a phase 3 trial is underway, in patients with relapsing mu
162 n this multicentre, double-blind, randomised phase 3 trial (JADE MONO-1), patients (aged >=12 years)
164 tamol PET and corresponding MR images from a phase II trial (<em>n</em> = 70), including subjects ran
168 specified open-label extension analysis of a phase 1 trial (NCT00412321) and a phase 2 trial (NCT0102
169 escribed here is a participant in an ongoing phase I trial (NCT00902044; active, not recruiting), and
170 lysis of a phase 1 trial (NCT00412321) and a phase 2 trial (NCT01024036), done at 26 hospitals worldw
175 server-blind, randomized, placebo-controlled phase I trial (NCT03300050), safety and immunogenicity o
176 afety and immunogenicity data from this U.S. phase 1 trial of two vaccine candidates in younger and o
183 y videos were prospectively collected from a phase 2 trial of mirikizumab with 249 patients from 14 c
184 nducted a 12-week, randomized, double-blind, phase 2 trial of nemolizumab (at a dose of 0.5 mg per ki
193 mmunoglobulin A [IgA]) immune responses in a phase 2 trial of Takeda's bivalent norovirus virus-like
194 andomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D(3) supplementation in c
195 ion in confirmed disability progression in a phase 3 trial of patients with relapsing multiple sclero
198 educed relapse rates and MRI activity in two phase 3 trials of patients with relapsing multiple scler
199 localized-stage FL, uniformly treated within phase 3 trials of the German Low-Grade Lymphoma Study Gr
205 dose escalation by post hoc analysis of the phase III trial of rupatadine for Japanese patients with
206 igh SVR12 rates, equivalent to those seen in Phase III trials of other pangenotypic options, and has
208 a measure of deviation between instantaneous phases of trials) of low frequency local field potential
209 nt advances in preclinical studies and early phase clinical trials offer renewed promise for immunolo
211 andomised, placebo-controlled, double-blind, phase 1 trial, participants were enrolled at the Nationa
215 nt complete) randomised, placebo-controlled, phase 3 trial, patients aged 18 years or older who had p
216 this randomised, double-blind, multicentre, phase 3 trial, patients aged 18 years or older with rela
217 against the allogeneic donor.METHODSIn this phase I trial, patients received either 1.5 x 106 MICs p
220 In a prospective, multicenter, randomized phase III trial, patients with cN0 early breast cancer o
223 andomised, double-blind, placebo-controlled, phase 2 trial, postmenopausal women aged at least 18 yea
225 ies for this group of disorders are in early-phase clinical trial, realistic expectations are that su
230 randomized, placebo-controlled, double-blind phase II trial (SORMAIN; German Clinical Trials Register
231 , and has moved at an unprecedented speed: a phase I trial started in March 2020 and there are curren
235 allel-group, placebo-controlled, multicentre phase 2 trial that evaluated the safety and efficacy of
237 , randomised, open-label, active-controlled, phase 3 trial that enrolled patients between Feb 9, 2015
238 ouble-blind, randomised, placebo-controlled, phase 3 trial that was done at 204 centres in 25 countri
239 T01513239, respectively), global, randomized phase 3 trials that assessed the efficacy and safety of
242 pite promising preclinical results and early-phase clinical trials, the goal of developing safe, effe
244 of efficacy awaits an appropriately powered phase 3 trial, this randomized, controlled, multicenter
245 Network multicenter, open-label, randomized phase 2 trial to estimate the difference in day 28 compl
247 eek, randomized, double-blind, double-dummy, phase 2 trial to investigate the efficacy and safety of
249 andomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus
251 open-label, randomized, multicenter, two-arm phase II trial to investigate cisplatin and gemcitabine
253 820 men with mCRPC randomly assigned in nine phase III trials to DP or a DP-containing regimen were c
257 here have guided the design of confirmatory Phase IV trials using ATIV to provide tools to identify
264 05, to Sept 15, 2009, and enrolment into the phase 2 trial was from Feb 9, 2010, to Feb 3, 2012.
266 ouble-blind, placebo-controlled, randomised, phase 3 trial was done at 16 university-affiliated centr
267 andomised, double-blind, placebo-controlled, phase 3 trial was done at 36 treatment centres in the US
268 ouble-blind, randomised, placebo-controlled, phase 3 trial was done at 86 sites in 13 countries acros
269 entre, double-blind, randomised, controlled, phase 3 trial was done in 130 academic centres, communit
272 ospective, pooled analysis of six randomised phase 3 trials was done to investigate disease-free surv
273 lticenter, double-blind, placebo-controlled, phase III trial was conducted across 39 centers in 13 co
274 ELIANA, a global, single-arm, open-label, phase 2 trial, was done in 25 hospitals across Australia
275 This randomised, open-label, non-inferiority phase 3 trial, was done at two research sites in Johanne
276 This multicentre, open-label, randomised, phase 3 trial, was done in 159 academic centres in Germa
279 andomized, double-blind, placebo-controlled, phase 2 trial, we administered a series of three monthly
280 ncology multicentre, randomised, open-label, phase 2 trial, we enrolled eligible adults (aged >=18 ye
282 In this double-blind, placebo-controlled, phase 2 trial, we enrolled patients with or without hete
286 In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned in a 2:1 ratio 65 pa
288 In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients undergoing
291 s), open-label, non-inferiority, randomised, phase 3 trial, we recruited adult patients (age >=18 yea
293 ospective, pooled analysis of six randomised phase 3 trials, we included patients with stage III colo
298 a novel treatment can be obtained in current phase I trials, which can therefore be considered to hav