Study 1 (Profile 1007)

Question 1

Study design

Answer 1

Randomized, multicenter, open label, active controlled study

Question 2

Total number of patients

Answer 2

347

Question 3

Patients had been previously treat with………

Answer 3

one platinum based chemotherapy regimen

Question 4

Xalkori dose

Answer 4

250mg BID

Question 5

of Xalkori pts

Answer 5

173

Question 6

of chemo pts

Answer 6

174

Question 7

Type of chemo used

Answer 7

Pemetrexed 500 (if naïve to it) or Docetaxil 75 intravenous every 21 days

Question 8

OS

Answer 8

not reached

Question 9

after progression ……….number and % of chemo patients received Xalkori

Answer 9

112 (64%)

Question 10

ORR vs chemo

Answer 10

65% vs. 20%

Question 11

Duration of response vs chemo

Answer 11

7.4 months vs. 5.6

Question 12

Progression free survival vs. chemo

Answer 12

7.7 vs. 3.0

Question 13

Eye disorder %

Answer 13

60%

Question 14

Diarrhea %

Answer 14

60%

Question 15

Nausea %

Answer 15

55%

Question 16

Constipation %

Answer 16

42%

Question 17

Elevation of ALT any grade vs. chemo

Answer 17

76% vs. 38%

Question 18

Elevation of AST any grade vs. chemo

Answer 18

61% vs. 33%

Question 19

% of serious AE reported for Xalkori and Chemo

Answer 19

37.2% vs. 23.4%

Question 20

Most frequent serious AE’s with Xalkori (4)

Answer 20

1. Pneumonia (4.1%)
2. PE (3.5%)
3. Dsypnea (2.3)
4. ILD (2.9%(

Question 21

Fatal AE’s occurred in ….. Xalkori patients

Answer 21

9 (5%)