Date of first round report: 1 September 2016 Date of second round report: 30 January 2017



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Safety questions/responses

  1. Safety clinical question 1


QUESTION 1

The sponsor is requested to provide a table which integrates from all clinical studies (referencing the source studies) and presents:

    1. the total number of patients treated to date:

  1. at the proposed dose level and regimen (palbociclib 125 md QD 3/1)

  2. 1. in combination with fulvestrant

        1. 2. in combination with letrozole at the proposed dose

        2. 3. in combination with letrozole at any dose level

  3. as monotherapy

  1. at the proposed dose and schedule

  2. at any other dose

  1. b. the median duration of treatment for all those patients and an interquartile range

  2. in combination with fulvestrant

  3. in combination with letrozole at the proposed dose

  4. in combination with letrozole at any dose level

Sponsor Response


Table 40 summarises the number of patients treated from clinical studies as requested:

Table 40: Number of patients treated from clinical studies



Table 41 summarises the median duration of treatment for the patients treated including an interquartile range as requested:

Table 41: Median duration of treatment


Evaluator comment:


It is presumed that ‘Table’ in the response refers to ‘Table Median Duration of Treatment’.

The sponsor’s response is accepted.


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