It has been reported in Phase 2a challenge trials of RTS,S/AS02A [40], [40], RTS,S/AS01B (personal communication, K. Kester) and heterologous prime-boost immunization regimens with antigen based on thrombospondin-related adhesion protein (TRAP) [41], [42] that elevated antigen-specific IFN-γ responses are associated with a delay in the prepatent period and protection against parasitemia.
Encouraging results have been reported in Phase I [ 94] and II studies [ 95].
A case of serious drug-related hepatotoxicity has been reported in phase IIb/III studies with maraviroc.
Promising responses, some durable, have been reported in phase I and II studies in melanoma, non-small-cell lung cancer [ 42, 43], and, more recently, renal cell cancer.
Favorable results, comparable with the results achieved with carboplatin monotherapy in phase II studies, have been reported in phase II studies for the combination of carboplatin and cyclophosphamide or ifosfamide, but these regimens have never been tested within randomised phase III including only patients with advanced seminoma.
The feasibility of concurrent treatment with single-agent docetaxel and radiotherapy for unresectable advanced NSCLC was established in a series of small phase I studies (Koukourakis et al, 1998; Mauer et al, 1998), and response rates of up to 80% have been reported in phase II trials in this setting (Kim and Khuri, 2002).
bEarthquake related material loss was reported in phase I (1990 1992).
16 One case of systemic lupus erythematosus (SLE) was reported in Phase III clinical trials.
A higher number of injuries were reported in Phase I (n = 2242) than in Phase II (n = 984; p < 0.01) of training, with the highest rate of injury occurring in week two.
No serious adverse haematological events related to drug treatment were reported in phase I studies of YM155 in single-agent therapy (Tolcher et al, 2008; Satoh et al, 2009).
A similar range of response rates (47 76%) was reported in phase III studies of platinum-based combination therapies (Parmar et al, 2003; Pfisterer et al, 2005; Pujade-Lauraine et al, 2010; Ushijima, 2010).
