Table 4

European Public Assessment Report summary screen versions: original (round 3) and revised (round 4)

Original (round 3)Revised (round 4)
QuestionsNumber of points found /understoodTarget met?Number found/understoodTarget met?
1Who has this report been written for?  4 / 0No  10 / 9Yes
2When is Bondronat used in breast cancer?  9 / 1No  10 / 9Yes
3What is the purpose of this report?  6 / 0No  9 / 9Yes
4What can the tablets do to the food pipe?  10 / 0No  10 / 10Yes
5Who made the decision about Bondronat described in this report?  9 / 0No  10 / 9Yes
6What group of medicines does Bondronat belong to?  5 / 5No  10 / 10Yes
7What did the Committee for Medicinal Products for Human Use (CHMP) decide about Bondronat?  9 / 8Yes  10 / 9Yes
8The tablets can irritate the food pipe. Which people cannot have the tablets as a result of this?  10 / 9Yes  9 / 8Yes
9What two things were weighed up before the decision was made about whether Bondronat should be approved?  3 / 3No  10 / 10Yes
10How does Bondronat prevent fractures, or broken bones?  10 / 9Yes  7 / 6No
11In the studies looking into bone problems or complications, what was looked at to see if Bondronat was working?  8 / 8No  7 / 7No
12During the studies into high calcium levels, how many people did the 4 mg dose work in?  7 / 7No  10 / 9Yes
13How many people receiving a Bondronat infusion got a fever?  10 / 9Yes  10 / 9Yes
14During the study of bone complications, what was Bondronat compared with?  10 / 8No  10 / 10Yes
15Suppose you want more information on how the decision was made about Bondronat, what should you do?  7 / 2No  10 / 9Yes
16How many people taking the Bondronat tablet got an inflamed food pipe?  9 / 8Yes  10 / 10Yes
17In the research studies of high calcium levels in the blood, what was Bondronat compared against?  7 / 7No  9 / 9Yes
18When Bondronat was studied in the treatment of bone complications, which group of patients got a new bone problem first?  6 / 5No  8 / 5No
19If you are a patient and want more information about Bondronat, what should you do?  9 / 9Yes  10 / 10Yes
Total number of passes616