Trial Outcomes & Findings for Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX) (NCT NCT00278889)
NCT ID: NCT00278889
Last Updated: 2012-10-24
Results Overview
Number of months from randomisation to the earlier date of objective progression or death
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
215 participants
Primary outcome timeframe
Randomisation to data cut-off date of November 2007
Results posted on
2012-10-24
Participant Flow
Participant milestones
| Measure |
FOLFOX + Cediranib 20 mg
FOLFOX + Cediranib 20 mg
|
FOLFOX + Cediranib 30 mg
FOLFOX + Cediranib 30 mg
|
FOLFOX + Bevacizumab 10 mg/kg
FOLFOX + Bevacizumab 10 mg/kg
|
|---|---|---|---|
|
Overall Study
STARTED
|
73
|
74
|
68
|
|
Overall Study
Overall Survival Analysis
|
16
|
20
|
19
|
|
Overall Study
COMPLETED
|
48
|
47
|
48
|
|
Overall Study
NOT COMPLETED
|
25
|
27
|
20
|
Reasons for withdrawal
| Measure |
FOLFOX + Cediranib 20 mg
FOLFOX + Cediranib 20 mg
|
FOLFOX + Cediranib 30 mg
FOLFOX + Cediranib 30 mg
|
FOLFOX + Bevacizumab 10 mg/kg
FOLFOX + Bevacizumab 10 mg/kg
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Death
|
24
|
21
|
17
|
Baseline Characteristics
Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)
Baseline characteristics by cohort
| Measure |
FOLFOX + Cediranib 20 mg
n=71 Participants
FOLFOX + Cediranib 20 mg
|
FOLFOX + Cediranib 30 mg
n=73 Participants
FOLFOX + Cediranib 30 mg
|
FOLFOX + Bevacizumab 10 mg/kg
n=66 Participants
FOLFOX + Bevacizumab 10 mg/kg
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
Age
|
63.9 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
63.5 Years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
61.8 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
63.07 Years
STANDARD_DEVIATION 9.63 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Randomisation to data cut-off date of November 2007Number of months from randomisation to the earlier date of objective progression or death
Outcome measures
| Measure |
FOLFOX + Cediranib 20 mg
n=71 Participants
FOLFOX + Cediranib 20 mg
|
FOLFOX + Cediranib 30 mg
n=73 Participants
FOLFOX + Cediranib 30 mg
|
FOLFOX + Bevacizumab 10 mg/kg
n=66 Participants
FOLFOX + Bevacizumab 10 mg/kg
|
|---|---|---|---|
|
Progression Free Survival
|
5.8 Months
Interval 3.9 to 8.9
|
7.2 Months
Interval 4.6 to 8.8
|
7.8 Months
Interval 5.3 to 10.8
|
SECONDARY outcome
Timeframe: Randomisation to data cut-off date of November 2007Per RECIST Criteria (V1.0) and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= ##% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Confirmed Partial Response (PR) or Complete Response (CR) as defined by RECIST.
Outcome measures
| Measure |
FOLFOX + Cediranib 20 mg
n=71 Participants
FOLFOX + Cediranib 20 mg
|
FOLFOX + Cediranib 30 mg
n=73 Participants
FOLFOX + Cediranib 30 mg
|
FOLFOX + Bevacizumab 10 mg/kg
n=66 Participants
FOLFOX + Bevacizumab 10 mg/kg
|
|---|---|---|---|
|
Objective Response Rate
|
13 Participants
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Randomisation to data cut-off date of 30 January 2009Number of months from randomisation to the date of death from any cause
Outcome measures
| Measure |
FOLFOX + Cediranib 20 mg
n=71 Participants
FOLFOX + Cediranib 20 mg
|
FOLFOX + Cediranib 30 mg
n=73 Participants
FOLFOX + Cediranib 30 mg
|
FOLFOX + Bevacizumab 10 mg/kg
n=66 Participants
FOLFOX + Bevacizumab 10 mg/kg
|
|---|---|---|---|
|
Overall Survival
|
14.3 Months
Interval 8.6 to 26.4
|
16.8 Months
Interval 9.4 to 31.1
|
19.6 Months
Interval 12.1 to 27.1
|
SECONDARY outcome
Timeframe: Randomisation to data cut-off date of November 2007Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires
Outcome measures
| Measure |
FOLFOX + Cediranib 20 mg
n=64 Participants
FOLFOX + Cediranib 20 mg
|
FOLFOX + Cediranib 30 mg
n=67 Participants
FOLFOX + Cediranib 30 mg
|
FOLFOX + Bevacizumab 10 mg/kg
n=60 Participants
FOLFOX + Bevacizumab 10 mg/kg
|
|---|---|---|---|
|
Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)
|
63 Days
Interval 39.0 to 143.0
|
74 Days
Interval 35.0 to 218.0
|
87 Days
Interval 56.0 to 225.0
|
SECONDARY outcome
Timeframe: Randomisation to data cut-off date of November 2007Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires
Outcome measures
| Measure |
FOLFOX + Cediranib 20 mg
n=63 Participants
FOLFOX + Cediranib 20 mg
|
FOLFOX + Cediranib 30 mg
n=67 Participants
FOLFOX + Cediranib 30 mg
|
FOLFOX + Bevacizumab 10 mg/kg
n=59 Participants
FOLFOX + Bevacizumab 10 mg/kg
|
|---|---|---|---|
|
QOL: Time to Worsening of Treatment-free Survival (TFS)
|
98 Days
Interval 43.0 to 171.0
|
112 Days
Interval 54.0 to 218.0
|
147 Days
Interval 61.0 to 231.0
|
SECONDARY outcome
Timeframe: Randomisation to data cut-off date of November 2007Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
Outcome measures
| Measure |
FOLFOX + Cediranib 20 mg
n=64 Participants
FOLFOX + Cediranib 20 mg
|
FOLFOX + Cediranib 30 mg
n=67 Participants
FOLFOX + Cediranib 30 mg
|
FOLFOX + Bevacizumab 10 mg/kg
n=60 Participants
FOLFOX + Bevacizumab 10 mg/kg
|
|---|---|---|---|
|
QOL: Time to Worsening of Clear Cell Sarcoma (CCS)
|
84 Days
Interval 41.0 to 159.0
|
74 Days
Interval 35.0 to 224.0
|
87 Days
Interval 56.0 to 188.0
|
SECONDARY outcome
Timeframe: Randomisation to data cut-off date of November 2007Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
Outcome measures
| Measure |
FOLFOX + Cediranib 20 mg
n=70 Participants
FOLFOX + Cediranib 20 mg
|
FOLFOX + Cediranib 30 mg
n=69 Participants
FOLFOX + Cediranib 30 mg
|
FOLFOX + Bevacizumab 10 mg/kg
n=60 Participants
FOLFOX + Bevacizumab 10 mg/kg
|
|---|---|---|---|
|
QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)
|
106 Days
Interval 51.0 to 163.0
|
92 Days
Interval 35.0 to 221.0
|
155 Days
Interval 56.0 to 232.0
|
Adverse Events
FOLFOX + Cediranib 20 mg
Serious events: 30 serious events
Other events: 69 other events
Deaths: 0 deaths
FOLFOX + Cediranib 30 mg
Serious events: 39 serious events
Other events: 73 other events
Deaths: 0 deaths
FOLFOX + Bevacizumab 10 mg/kg
Serious events: 29 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FOLFOX + Cediranib 20 mg
n=73 participants at risk
FOLFOX + Cediranib 20 mg
|
FOLFOX + Cediranib 30 mg
n=74 participants at risk
FOLFOX + Cediranib 30 mg
|
FOLFOX + Bevacizumab 10 mg/kg
n=68 participants at risk
FOLFOX + Bevacizumab 10 mg/kg
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
1/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Cardiac disorders
Atrial Fibrillation
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Eye disorders
Blindness
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.7%
4/70
|
0.00%
0/73
|
4.5%
3/66
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
2/70
|
4.1%
3/73
|
4.5%
3/66
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
4.3%
3/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/70
|
1.4%
1/73
|
3.0%
2/66
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/70
|
2.7%
2/73
|
0.00%
0/66
|
|
Gastrointestinal disorders
Abdominal Symptom
|
0.00%
0/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Gastrointestinal disorders
Colonic Obstruction
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Gastrointestinal disorders
Gastrointestinal Obstruction
|
0.00%
0/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Gastrointestinal disorders
Gastrointestinal Toxicity
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Gastrointestinal disorders
Ileus
|
1.4%
1/70
|
1.4%
1/73
|
1.5%
1/66
|
|
Gastrointestinal disorders
Ileus Paralytic
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.00%
0/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Gastrointestinal disorders
Small Intestinal Perforation
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
Gastrointestinal disorders
Subileus
|
1.4%
1/70
|
1.4%
1/73
|
1.5%
1/66
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
General disorders
Asthenia
|
0.00%
0/70
|
4.1%
3/73
|
0.00%
0/66
|
|
General disorders
Pyrexia
|
1.4%
1/70
|
2.7%
2/73
|
3.0%
2/66
|
|
General disorders
Fatigue
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
General disorders
Infusion Site Extravasation
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
General disorders
Malaise
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/70
|
0.00%
0/73
|
1.5%
1/66
|
|
General disorders
Sudden Cardiac Death
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Hepatobiliary disorders
Bile Duct Stone
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/70
|
1.4%
1/73
|
1.5%
1/66
|
|
Infections and infestations
Infection
|
0.00%
0/70
|
0.00%
0/73
|
3.0%
2/66
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/70
|
0.00%
0/73
|
3.0%
2/66
|
|
Infections and infestations
Bronchitis
|
0.00%
0/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Infections and infestations
Central Line Infection
|
0.00%
0/70
|
1.4%
1/73
|
1.5%
1/66
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
Infections and infestations
Klebsiella Bacteraemia
|
0.00%
0/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Infections and infestations
Lobar Pneumonia
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
Infections and infestations
Lung Infection
|
1.4%
1/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Infections and infestations
Pneumonia
|
0.00%
0/70
|
1.4%
1/73
|
1.5%
1/66
|
|
Infections and infestations
Respiratory Tract Infection
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
Infections and infestations
Sepsis
|
0.00%
0/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Infections and infestations
Sepsis Syndrome
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
Injury, poisoning and procedural complications
Anastomotic Complication
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
Injury, poisoning and procedural complications
Anastomotic Ulcer
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Injury, poisoning and procedural complications
Blood Creatinine Increased
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
Injury, poisoning and procedural complications
Weight Decreased
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/70
|
4.1%
3/73
|
1.5%
1/66
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/70
|
2.7%
2/73
|
1.5%
1/66
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Nervous system disorders
Convulsion
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Nervous system disorders
Headache
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
Nervous system disorders
Somnolence
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Psychiatric disorders
Confusional State
|
1.4%
1/70
|
2.7%
2/73
|
0.00%
0/66
|
|
Psychiatric disorders
Agitation
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Renal and urinary disorders
Hydronephrosis
|
1.4%
1/70
|
0.00%
0/73
|
0.00%
0/66
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Renal and urinary disorders
Ureteric Obstruction
|
0.00%
0/70
|
0.00%
0/73
|
1.5%
1/66
|
Other adverse events
| Measure |
FOLFOX + Cediranib 20 mg
n=73 participants at risk
FOLFOX + Cediranib 20 mg
|
FOLFOX + Cediranib 30 mg
n=74 participants at risk
FOLFOX + Cediranib 30 mg
|
FOLFOX + Bevacizumab 10 mg/kg
n=68 participants at risk
FOLFOX + Bevacizumab 10 mg/kg
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
52.9%
37/70
|
43.8%
32/73
|
43.9%
29/66
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
37.1%
26/70
|
39.7%
29/73
|
22.7%
15/66
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.9%
9/70
|
11.0%
8/73
|
7.6%
5/66
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
7/70
|
9.6%
7/73
|
7.6%
5/66
|
|
Endocrine disorders
Hypothyroidism
|
2.9%
2/70
|
6.8%
5/73
|
1.5%
1/66
|
|
Gastrointestinal disorders
Diarrhoea
|
74.3%
52/70
|
74.0%
54/73
|
63.6%
42/66
|
|
Gastrointestinal disorders
Nausea
|
50.0%
35/70
|
56.2%
41/73
|
57.6%
38/66
|
|
Gastrointestinal disorders
Stomatitis
|
31.4%
22/70
|
45.2%
33/73
|
37.9%
25/66
|
|
Gastrointestinal disorders
Vomiting
|
31.4%
22/70
|
38.4%
28/73
|
37.9%
25/66
|
|
Gastrointestinal disorders
Abdominal Pain
|
25.7%
18/70
|
28.8%
21/73
|
21.2%
14/66
|
|
Gastrointestinal disorders
Constipation
|
24.3%
17/70
|
17.8%
13/73
|
27.3%
18/66
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
11.4%
8/70
|
8.2%
6/73
|
7.6%
5/66
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
7/70
|
5.5%
4/73
|
7.6%
5/66
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
1.4%
1/70
|
1.4%
1/73
|
9.1%
6/66
|
|
Gastrointestinal disorders
Dysphagia
|
8.6%
6/70
|
4.1%
3/73
|
4.5%
3/66
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/70
|
1.4%
1/73
|
9.1%
6/66
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
8.6%
6/70
|
1.4%
1/73
|
0.00%
0/66
|
|
Gastrointestinal disorders
Dry Mouth
|
4.3%
3/70
|
6.8%
5/73
|
1.5%
1/66
|
|
Gastrointestinal disorders
Toothache
|
7.1%
5/70
|
4.1%
3/73
|
4.5%
3/66
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
2.9%
2/70
|
5.5%
4/73
|
4.5%
3/66
|
|
Gastrointestinal disorders
Proctalgia
|
5.7%
4/70
|
0.00%
0/73
|
1.5%
1/66
|
|
General disorders
Fatigue
|
50.0%
35/70
|
56.2%
41/73
|
59.1%
39/66
|
|
General disorders
Asthenia
|
24.3%
17/70
|
21.9%
16/73
|
13.6%
9/66
|
|
General disorders
Pyrexia
|
18.6%
13/70
|
17.8%
13/73
|
22.7%
15/66
|
|
General disorders
Oedema Peripheral
|
2.9%
2/70
|
4.1%
3/73
|
7.6%
5/66
|
|
General disorders
Chills
|
5.7%
4/70
|
4.1%
3/73
|
4.5%
3/66
|
|
General disorders
Mucosal Inflammation
|
2.9%
2/70
|
1.4%
1/73
|
6.1%
4/66
|
|
Immune system disorders
Drug Hypersensitivity
|
5.7%
4/70
|
2.7%
2/73
|
7.6%
5/66
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
4/70
|
6.8%
5/73
|
10.6%
7/66
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
7/70
|
9.6%
7/73
|
7.6%
5/66
|
|
Infections and infestations
Bronchitis
|
4.3%
3/70
|
5.5%
4/73
|
7.6%
5/66
|
|
Infections and infestations
Weight Decreased
|
24.3%
17/70
|
9.6%
7/73
|
12.1%
8/66
|
|
Infections and infestations
Aspartate Aminotransferase Increased
|
7.1%
5/70
|
5.5%
4/73
|
1.5%
1/66
|
|
Infections and infestations
Alanine Aminotransferase Increased
|
5.7%
4/70
|
5.5%
4/73
|
0.00%
0/66
|
|
Metabolism and nutrition disorders
Anorexia
|
41.4%
29/70
|
32.9%
24/73
|
43.9%
29/66
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.1%
12/70
|
6.8%
5/73
|
7.6%
5/66
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
3/70
|
9.6%
7/73
|
6.1%
4/66
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
5.7%
4/70
|
6.8%
5/73
|
6.1%
4/66
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.3%
3/70
|
1.4%
1/73
|
7.6%
5/66
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.1%
5/70
|
8.2%
6/73
|
19.7%
13/66
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
5.7%
4/70
|
13.7%
10/73
|
12.1%
8/66
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
7/70
|
8.2%
6/73
|
6.1%
4/66
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
7.1%
5/70
|
4.1%
3/73
|
9.1%
6/66
|
|
Nervous system disorders
Paraesthesia
|
28.6%
20/70
|
42.5%
31/73
|
36.4%
24/66
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
28.6%
20/70
|
23.3%
17/73
|
37.9%
25/66
|
|
Nervous system disorders
Headache
|
14.3%
10/70
|
21.9%
16/73
|
24.2%
16/66
|
|
Nervous system disorders
Neuropathy Peripheral
|
12.9%
9/70
|
8.2%
6/73
|
18.2%
12/66
|
|
Nervous system disorders
Dysgeusia
|
15.7%
11/70
|
12.3%
9/73
|
15.2%
10/66
|
|
Nervous system disorders
Dysaesthesia
|
5.7%
4/70
|
2.7%
2/73
|
10.6%
7/66
|
|
Nervous system disorders
Dizziness
|
8.6%
6/70
|
5.5%
4/73
|
6.1%
4/66
|
|
Nervous system disorders
Polyneuropathy
|
8.6%
6/70
|
4.1%
3/73
|
6.1%
4/66
|
|
Nervous system disorders
Lethargy
|
7.1%
5/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Psychiatric disorders
Insomnia
|
7.1%
5/70
|
9.6%
7/73
|
7.6%
5/66
|
|
Psychiatric disorders
Anxiety
|
2.9%
2/70
|
5.5%
4/73
|
6.1%
4/66
|
|
Renal and urinary disorders
Proteinuria
|
18.6%
13/70
|
17.8%
13/73
|
22.7%
15/66
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
31.4%
22/70
|
28.8%
21/73
|
19.7%
13/66
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.1%
12/70
|
20.5%
15/73
|
19.7%
13/66
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.6%
6/70
|
5.5%
4/73
|
16.7%
11/66
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.4%
8/70
|
13.7%
10/73
|
9.1%
6/66
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/70
|
1.4%
1/73
|
6.1%
4/66
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.4%
1/70
|
5.5%
4/73
|
4.5%
3/66
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
17.1%
12/70
|
11.0%
8/73
|
10.6%
7/66
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.6%
6/70
|
11.0%
8/73
|
15.2%
10/66
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
2/70
|
1.4%
1/73
|
12.1%
8/66
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/70
|
11.0%
8/73
|
12.1%
8/66
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.7%
4/70
|
9.6%
7/73
|
1.5%
1/66
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/70
|
5.5%
4/73
|
3.0%
2/66
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
5.7%
4/70
|
0.00%
0/73
|
1.5%
1/66
|
|
Vascular disorders
Hypertension
|
50.0%
35/70
|
58.9%
43/73
|
48.5%
32/66
|
|
Vascular disorders
Pallor
|
0.00%
0/70
|
5.5%
4/73
|
1.5%
1/66
|
Additional Information
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