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Following the meeting the protocol was approved for implementation.
Analyses in a 'per protocol set (PPS)', the population meeting the protocol criteria, were also performed.
Patients meeting the protocol criteria were informed about the study aims and procedures.
The reasons why they had not been dosed included not meeting the protocol selection criteria or cancellation of the studies.
Of these, 159 patients meeting the protocol stipulation and condition were recruited and randomized to receive either progesterone (n = 82) or placebo (n = 77).
The investigator must report every event meeting the protocol definition of an SAE to the coordinating investigator until the next working day after having become aware of the event.
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Patients not meeting the protocol-defined responder criteria were also randomized and followed in the study.
* Includes patients not meeting the protocol-specified, progressively stricter glycemic rescue criteria and/or not meeting the investigator's expectations of glycemic improvement.
Hypoglycaemia was the most frequently reported TEAE in the lixisenatide group — 66 (42.9%) lixisenatide-treated patients and 37 (23.6%) placebo-treated patients reported symptomatic hypoglycaemia meeting the protocol-specified definition.
Events of hypoglycemia were classified as not requiring assistance, requiring the (nonmedical) assistance of others, and meeting the protocol-specified definition of severity (i.e., requiring medical intervention or exhibiting markedly depressed level of consciousness, including loss of consciousness or seizure).
The 6-month PFS rate for patients who received TMZ was 21%, which met the protocol objective.
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