Table 3

Changes made in round 1 related to the responses to specific questions

QuestionChanges made
2When is Bondronat used in breast cancer?Original long sentence with multiple bracketing incorporated into 2 new subheadings, separated into dedicated bullet points
3What is the purpose of this report?Original text in italics in box at beginning became part of main document under new heading ‘Who is this report for’
4What can the tablets do to the oesophagus or food pipe?In original, mentioned both in the ‘How is Bondronat used’ section and ‘What is the risk’ section in isolation. Changed so clear in both places what problem was, and how it related to necessary actions
5Who made the decision about Bondronat described in this report?Original did not make clear the membership of CHMP—remedied in revised version under the heading ‘Who made the decision?’ in first section of the document
11In the studies looking into bone problems or complications, what was looked at to see if Bondronat was working?Answer was number of new bone complications—in original in middle of paragraph containing variety of pieces of information about the study. Revision included new subheading ‘What did the studies look for’
13How many people receiving a Bondronat infusion got a fever?Original listed side effects in long paragraph with long sentences. Revision bulleted the side effects, and separated out those relating to ‘drip’ and tablets
15Suppose you want more information on how the decision was made about Bondronat, what should you do?Information moved from original boxed italicised text into a new subsection titled ‘Where to get more information’
16How many people taking the Bondronat tablet got an inflamed food pipe?Information became part of bulleted list of side effects (see above), and frequency simplified from ‘seen in between 1 and 10 patients in a hundred’ to ‘affects less than 1 in 10 people’