The patients were followed up from diagnosis until death, emigration or to the end of 2005, whichever came first: for a few (0.13%), the follow-up was terminated owing to emigration.
Translation of these studies to treat hamartomas clinically with rapalogs has proven successful in tuberous sclerosis and lymphangioleiomyomatosis patients with the MILES trial (Bissler et al, 2008; McCormack et al, 2011), whereas early phase clinical trial for PJS patients was terminated owing to low enrolment.
A phase II study of PD0325901 was assessed in 34 advanced non-small cell lung carcinoma patients, but was eventually terminated owing to lack of objective responses and increasing concerns about ocular function and neurotoxicity at therapeutic doses.
One clamp study was prematurely terminated owing to transient hypotension.
The ACCORD trial was prematurely terminated, owing to an excess of cardiovascular mortality in the intensive treatment group, possibly related to a three-fold higher rate of hypoglycemia.
Indeed, one clinical trial of atacicept in SLE, in combined regiments with mycophenolate mofetil, was prematurely terminated owing to an increase in infectious diseases (ClinicalTrial.gov identifier: NCT00573157).
In Frumin et al.'s experiments, two of eight human trials were prematurely terminated owing to development of ventricular arrhythmias [ 13], and in Draper et al.'s experiments, one of the 12 dogs died, most likely from carbon dioxide toxicity [ 11].
Evaluation of DAA was terminated early owing to its withdrawal from the market by Lilly [34].
30 This trial was terminated prematurely owing to overwhelming benefit, albeit in a small cohort.
Moreover, one clinical trial (ClinicalTrial.gov identifier: NCT00573157) with atacicept was terminated prematurely owing to an increased incidence of grade III infections in the group treated with atacicept.
