Trial Outcomes & Findings for Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma (NCT NCT00777153)

NCT ID: NCT00777153

Last Updated: 2016-12-28

Results Overview

For patients with measurable disease at entry (at least one lesion that has a shortest diameter ≥10 mm at baseline on 2 axial slices), PFS will be defined as the earliest time that: 1. The sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions has increased by a greater than or equal to 25% in comparison to the nadir scan as long as the shortest diameter is ≥15 mm. If the dose of steroids has been reduced within the 10 days prior to the scan being conducted, progression will be based on a follow-up scan performed after the dose of steroids has been stabilized for 10 days. 2. The patient has died from any cause. 3. A new lesion is detected that is outside the original tumor volume and has a shortest diameter ≥10 mm.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 423 participants
• Primary outcome timeframe: Baseline at 6 weeks and then every 6 weeks to discontinuation
• Results posted on: 2016-12-28

Participant Flow

423 patients were enrolled in to the study but did not start the study. They did not go on to be randomized.

Randomised=Full Analysis Set (ITT): Cediranib 30 mg=131, Cediranib 20 mg + Lomustine=129, Placebo + Lomustine=65; ITT with measurable disease at baseline (based on site review): Cediranib 30 mg=115, Cediranib 20 mg + Lomustine=112, Placebo + Lomustine=55; Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64

Participant milestones

Measure	Cediranib 30mg Cediranib 30mg/Day	Cediranib 20mg + Lomustine 110mg Cediranib 20mg/Day + Lomustine 110mg/m2/Day	Lomustine 110mg Lomustine 110mg/m2/Day + Placebo cediranib
Overall Study STARTED	131	129	65
Overall Study COMPLETED	41	46	28
Overall Study NOT COMPLETED	90	83	37

Reasons for withdrawal

Measure	Cediranib 30mg Cediranib 30mg/Day	Cediranib 20mg + Lomustine 110mg Cediranib 20mg/Day + Lomustine 110mg/m2/Day	Lomustine 110mg Lomustine 110mg/m2/Day + Placebo cediranib
Overall Study Lost to Follow-up	1	1	0
Overall Study Death	85	73	33
Overall Study Withdrawal by Subject	3	4	3
Overall Study Incorrect enrol/elig crit not fulfilled	1	5	1

Baseline Characteristics

Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma

Baseline characteristics by cohort

Measure	Cediranib 30mg n=131 Participants Cediranib 30mg/Day	Cediranib 20mg + Lomustine 110mg n=129 Participants Cediranib 20mg/Day + Lomustine 110mg/m2/Day	Lomustine 110mg n=65 Participants Lomustine 110mg/m2/Day + Placebo cediranib	Total n=325 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 11.81 • n=5 Participants	53.7 years STANDARD_DEVIATION 10.78 • n=7 Participants	52.0 years STANDARD_DEVIATION 13.09 • n=5 Participants	53.3 years STANDARD_DEVIATION 11.67 • n=4 Participants
Gender Female	46 Participants n=5 Participants	44 Participants n=7 Participants	24 Participants n=5 Participants	114 Participants n=4 Participants
Gender Male	85 Participants n=5 Participants	85 Participants n=7 Participants	41 Participants n=5 Participants	211 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline at 6 weeks and then every 6 weeks to discontinuation

For patients with measurable disease at entry (at least one lesion that has a shortest diameter

≥10 mm at baseline on 2 axial slices), PFS will be defined as the earliest time that:

1. The sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions has increased by a greater than or equal to 25% in comparison to the nadir scan as long as the shortest diameter is ≥15 mm. If the dose of steroids has been reduced within the 10 days prior to the scan being conducted, progression will be based on a follow-up scan performed after the dose of steroids has been stabilized for 10 days.

2. The patient has died from any cause.

3. A new lesion is detected that is outside the original tumor volume and has a shortest diameter ≥10 mm.

Outcome measures

Measure	Cediranib 30mg n=131 Participants Cediranib 30mg/Day	Cediranib 20mg+ Lomustine 110mg n=129 Participants Cediranib 20mg/Day + Lomustine 110mg/m2/Day	Lomustine 110mg n=65 Participants Lomustine 110mg/m2/Day + Placebo cediranib
Progression Free Survival (PFS)	92 Days Interval 80.0 to 128.0	125 Days Interval 83.0 to 201.0	82 Days Interval 42.0 to 168.0

SECONDARY outcome

Timeframe: Baseline through to date of death up to 25th April 2010

Number of months from randomisation to the date of death from any cause

Outcome measures

Measure	Cediranib 30mg n=131 Participants Cediranib 30mg/Day	Cediranib 20mg+ Lomustine 110mg n=129 Participants Cediranib 20mg/Day + Lomustine 110mg/m2/Day	Lomustine 110mg n=65 Participants Lomustine 110mg/m2/Day + Placebo cediranib
Overall Survival (OS)	8.0 Months Interval 4.1 to 14.5	9.4 Months Interval 6.2 to 14.5	9.8 Months Interval 4.9 to Third quartile has not been reached.

SECONDARY outcome

Timeframe: Baseline at 6 weeks and then every 6 weeks to discontinuation

Population: Patients are only included in the analysis if they have measurable disease at baseline based on central.

An individual visit response of PR was defined as a greater than or equal to 50% reduction in the sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions compared to baseline as long as the steroid dose has not been increased within the previous 10 days and no new lesions are present.

An individual visit response of CR was defined as the complete disappearance of all tumor on MRI scan.

Outcome measures

Measure	Cediranib 30mg n=118 Participants Cediranib 30mg/Day	Cediranib 20mg+ Lomustine 110mg n=122 Participants Cediranib 20mg/Day + Lomustine 110mg/m2/Day	Lomustine 110mg n=56 Participants Lomustine 110mg/m2/Day + Placebo cediranib
Response Rate	18 Participants	21 Participants	5 Participants

SECONDARY outcome

Timeframe: 6 Months

Proportion of patients alive and progression free at 6 months (based on central review) as estimated from Kaplan-Meier techniques. Values are percentages.

Outcome measures

Measure	Cediranib 30mg n=131 Participants Cediranib 30mg/Day	Cediranib 20mg+ Lomustine 110mg n=129 Participants Cediranib 20mg/Day + Lomustine 110mg/m2/Day	Lomustine 110mg n=65 Participants Lomustine 110mg/m2/Day + Placebo cediranib
Alive and Progression Free Rate at 6 Months (APF6)	16.2 % of patients alive and progression free	34.5 % of patients alive and progression free	24.5 % of patients alive and progression free

SECONDARY outcome

Timeframe: Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assed up to 2014-April-25

The mean steroid dosage prior to treatment will be considered as the patient's baseline. The percent change in average daily steroid dosage from baseline is calculated by following formula: PC = (md - bm)/bm*100; where PC is the percent change in average daily steroid dosage from baseline; md the mean daily steroid dosage recorded from the first day of therapy to progression; and bm the baseline mean.

Outcome measures

Measure	Cediranib 30mg n=61 Participants Cediranib 30mg/Day	Cediranib 20mg+ Lomustine 110mg n=68 Participants Cediranib 20mg/Day + Lomustine 110mg/m2/Day	Lomustine 110mg n=26 Participants Lomustine 110mg/m2/Day + Placebo cediranib
Daily Steroid Dose	-17.6 percentage of change	-1.8 percentage of change	36.6 percentage of change

SECONDARY outcome

Timeframe: Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assessed up to 2014-April-25

Number of days known not to have used any steroids prior to progression

Outcome measures

Measure	Cediranib 30mg n=128 Participants Cediranib 30mg/Day	Cediranib 20mg+ Lomustine 110mg n=123 Participants Cediranib 20mg/Day + Lomustine 110mg/m2/Day	Lomustine 110mg n=64 Participants Lomustine 110mg/m2/Day + Placebo cediranib
Steroid Free Days	75.8 Days Standard Deviation 110.1	74.8 Days Standard Deviation 91.7	92.3 Days Standard Deviation 122.0

Adverse Events

Cediranib 30mg

Serious events: 55 serious events

Other events: 124 other events

Deaths: 0 deaths

Cediranib 20mg + Lomustine 110mg

Serious events: 45 serious events

Other events: 120 other events

Deaths: 0 deaths

Lomustine 110mg

Serious events: 26 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cediranib 30mg n=128 participants at risk Cediranib 30mg/Day	Cediranib 20mg + Lomustine 110mg n=123 participants at risk Cediranib 20mg/Day + Lomustine 110mg/m2/Day	Lomustine 110mg n=64 participants at risk Lomustine 110mg/m2/Day + Placebo cediranib
Blood and lymphatic system disorders Thrombocytopenia	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	6.5% 8/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Blood and lymphatic system disorders Neutropenia	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.1% 5/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Blood and lymphatic system disorders Anaemia	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	2.4% 3/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 2/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Blood and lymphatic system disorders Pancytopenia	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Cardiac disorders Acute Myocardial Infarction	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Cardiac disorders Angina Unstable	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Cardiac disorders Tachycardia	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Endocrine disorders Addison's Disease	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Endocrine disorders Hypothyroidism	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Abdominal Pain	1.6% 2/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Diarrhoea	1.6% 2/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 2/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Nausea	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 2/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Vomiting	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 2/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Dysphagia	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Rectal Haemorrhage	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Rectal Perforation	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
General disorders General Physical Health Deterioration	1.6% 2/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
General disorders Death	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
General disorders Fatigue	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
General disorders Gait Disturbance	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
General disorders Pyrexia	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Hepatobiliary disorders Cholecystitis	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Hepatobiliary disorders Hepatic Steatosis	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Immune system disorders Hypersensitivity	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Infections and infestations Pneumonia	3.1% 4/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	2.4% 3/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Infections and infestations Bronchitis	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 2/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Infections and infestations Bronchopneumonia	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Infections and infestations Cellulitis	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Infections and infestations Herpes Zoster	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Infections and infestations Herpes Zoster Ophthalmic	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Infections and infestations Influenza	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Infections and infestations Rectal Abscess	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Infections and infestations Sepsis	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Infections and infestations Wound Infection	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Injury, poisoning and procedural complications Concussion	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Injury, poisoning and procedural complications Feeding Tube Complication	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Injury, poisoning and procedural complications Head Injury	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Injury, poisoning and procedural complications Joint Dislocation	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Injury, poisoning and procedural complications Subdural Haematoma	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Investigations Alanine Aminotransferase Increased	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Metabolism and nutrition disorders Dehydration	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Metabolism and nutrition disorders Hypokalaemia	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Musculoskeletal and connective tissue disorders Arthralgia	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Musculoskeletal and connective tissue disorders Back Pain	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Musculoskeletal and connective tissue disorders Mobility Decreased	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Musculoskeletal and connective tissue disorders Muscle Haemorrhage	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Musculoskeletal and connective tissue disorders Muscular Weakness	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Haemorrhage	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Convulsion	8.6% 11/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	2.4% 3/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Grand Mal Convulsion	2.3% 3/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Hemiparesis	2.3% 3/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Cerebral Haemorrhage	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Headache	1.6% 2/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Hydrocephalus	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 2/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Ischaemic Stroke	1.6% 2/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Neurological Symptom	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Partial Seizures	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Aphasia	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Ataxia	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Cerebral Cyst	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Cerebral Haematoma	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Cerebral Venous Thrombosis	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Complex Partial Seizures	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Encephalopathy	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Intracranial Pressure Increased	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Ischaemic Cerebral Infarction	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Neurological Decompensation	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Peripheral Motor Neuropathy	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Sinus Headache	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Somnolence	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Speech Disorder	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Syncope	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Psychiatric disorders Confusional State	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 2/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Psychiatric disorders Mental Status Changes	1.6% 2/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Psychiatric disorders Aggression	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Psychiatric disorders Anxiety	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Psychiatric disorders Personality Change	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Psychiatric disorders Suicide Attempt	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Reproductive system and breast disorders Menorrhagia	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	3.1% 4/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.9% 6/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.7% 3/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Skin and subcutaneous tissue disorders Rash	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Skin and subcutaneous tissue disorders Skin Disorder	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Vascular disorders Deep Vein Thrombosis	1.6% 2/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.3% 4/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Vascular disorders Hypertension	2.3% 3/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Vascular disorders Haematoma	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Vascular disorders Phlebitis	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64

Other adverse events

Measure	Cediranib 30mg n=128 participants at risk Cediranib 30mg/Day	Cediranib 20mg + Lomustine 110mg n=123 participants at risk Cediranib 20mg/Day + Lomustine 110mg/m2/Day	Lomustine 110mg n=64 participants at risk Lomustine 110mg/m2/Day + Placebo cediranib
Blood and lymphatic system disorders Thrombocytopenia	4.7% 6/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	56.1% 69/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	43.8% 28/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Blood and lymphatic system disorders Neutropenia	1.6% 2/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	22.8% 28/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	12.5% 8/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Blood and lymphatic system disorders Leukopenia	1.6% 2/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	20.3% 25/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	17.2% 11/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Blood and lymphatic system disorders Anaemia	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	8.1% 10/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Blood and lymphatic system disorders Lymphopenia	4.7% 6/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	6.5% 8/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	12.5% 8/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Endocrine disorders Hypothyroidism	18.8% 24/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	8.1% 10/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Eye disorders Vision Blurred	3.9% 5/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.9% 6/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	6.2% 4/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Diarrhoea	71.1% 91/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	70.7% 87/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	17.2% 11/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Nausea	20.3% 26/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	29.3% 36/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	34.4% 22/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Constipation	20.3% 26/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	21.1% 26/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	25.0% 16/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Vomiting	7.8% 10/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	20.3% 25/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	10.9% 7/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Stomatitis	10.9% 14/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	2.4% 3/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Abdominal Pain	5.5% 7/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	8.9% 11/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Oral Pain	6.2% 8/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.1% 5/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	6.2% 4/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Abdominal Pain Upper	3.9% 5/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	5.7% 7/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	6.2% 4/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Dry Mouth	3.9% 5/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	5.7% 7/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Gastrointestinal disorders Faecal Incontinence	5.5% 7/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
General disorders Fatigue	50.8% 65/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	58.5% 72/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	46.9% 30/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
General disorders Oedema Peripheral	13.3% 17/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	13.0% 16/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	12.5% 8/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
General disorders Asthenia	3.9% 5/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	9.8% 12/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	7.8% 5/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Infections and infestations Upper Respiratory Tract Infection	4.7% 6/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	7.3% 9/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.7% 3/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Infections and infestations Urinary Tract Infection	3.9% 5/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	6.5% 8/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Injury, poisoning and procedural complications Contusion	5.5% 7/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	8.1% 10/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Injury, poisoning and procedural complications Fall	3.9% 5/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.9% 6/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	7.8% 5/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Investigations Platelet Count Decreased	2.3% 3/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	17.1% 21/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	14.1% 9/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Investigations White Blood Cell Count Decreased	0.00% 0/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	12.2% 15/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	10.9% 7/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Investigations Weight Decreased	4.7% 6/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	11.4% 14/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Investigations Alanine Aminotransferase Increased	3.1% 4/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	10.6% 13/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Investigations Gamma-Glutamyltransferase Increased	1.6% 2/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	10.6% 13/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Investigations Aspartate Aminotransferase Increased	1.6% 2/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	7.3% 9/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Metabolism and nutrition disorders Decreased Appetite	12.5% 16/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	22.8% 28/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	6.2% 4/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Musculoskeletal and connective tissue disorders Pain In Extremity	3.1% 4/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	9.8% 12/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	6.2% 4/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Musculoskeletal and connective tissue disorders Back Pain	5.5% 7/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	8.1% 10/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	10.9% 7/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Musculoskeletal and connective tissue disorders Muscular Weakness	7.8% 10/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	6.5% 8/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	9.4% 6/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 8/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	6.5% 8/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Musculoskeletal and connective tissue disorders Muscle Spasms	1.6% 2/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	5.7% 7/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.7% 3/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Headache	27.3% 35/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	32.5% 40/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	37.5% 24/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Convulsion	13.3% 17/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	7.3% 9/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	10.9% 7/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Dizziness	10.2% 13/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	5.7% 7/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	6.2% 4/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Aphasia	9.4% 12/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.3% 4/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.7% 3/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Lethargy	3.9% 5/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	5.7% 7/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.7% 3/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Nervous system disorders Hemiparesis	3.1% 4/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.3% 4/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	7.8% 5/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Psychiatric disorders Confusional State	7.8% 10/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.9% 6/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Psychiatric disorders Depression	5.5% 7/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	8.1% 10/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.7% 3/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Psychiatric disorders Anxiety	3.9% 5/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	7.3% 9/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.7% 3/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Psychiatric disorders Insomnia	7.0% 9/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	7.3% 9/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	12.5% 8/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Psychiatric disorders Agitation	6.2% 8/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Renal and urinary disorders Urinary Incontinence	7.8% 10/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.3% 4/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Renal and urinary disorders Polyuria	0.78% 1/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	6.2% 4/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Respiratory, thoracic and mediastinal disorders Dysphonia	30.5% 39/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	29.3% 36/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	9.4% 6/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Respiratory, thoracic and mediastinal disorders Cough	10.2% 13/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	13.0% 16/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	7.8% 5/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Respiratory, thoracic and mediastinal disorders Epistaxis	2.3% 3/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	8.9% 11/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.5% 7/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	8.1% 10/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Skin and subcutaneous tissue disorders Rash	10.2% 13/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	8.1% 10/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	1.6% 1/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Skin and subcutaneous tissue disorders Alopecia	8.6% 11/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	7.3% 9/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysaesthesia Syndrome	7.0% 9/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.81% 1/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	3.1% 2/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Skin and subcutaneous tissue disorders Dry Skin	5.5% 7/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.9% 6/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.7% 3/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Skin and subcutaneous tissue disorders Petechiae	3.1% 4/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	5.7% 7/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	0.00% 0/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Skin and subcutaneous tissue disorders Pruritus	3.9% 5/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	4.1% 5/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	6.2% 4/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64
Vascular disorders Hypertension	50.0% 64/128 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	46.3% 57/123 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64	6.2% 4/64 Adverse events are assessed on all patients who meet the Safety set criteria i.e. all patients who were randomized and received at least one dose of study drug. Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64

Additional Information

Gerard Lynch

AstraZeneca

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee If a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.
• Publication restrictions are in place

Restriction type: OTHER