Trial Outcomes & Findings for Effect of Food Upon Pharmacokinetics of Single Oral Dose of Cediranib (AZD2171, Recentin™) (NCT NCT00306891)
NCT ID: NCT00306891
Last Updated: 2012-11-01
Results Overview
Area under plasma concentration-time curve from zero to infinity
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Measurements were collected up to 168 hours (following single dosing).
Results posted on
2012-11-01
Participant Flow
This was a two part study.Part A had two arms, fed/fasted and fasted/fed. Part B had two arms, a fixed dose arm and a dose escalation arm.Patients(pts)in Part A were allowed to go in to Part B. Pts who chose not to go in to Part B discontinued the study.Additionally new pts were recruited to Part B. In Parts A/B, there was a total of 60 pts.
60 patients were enrolled though only 45 patients were randomized to Part A and 47 to Part B. Completion of Part B means completed at least 16 weeks of treatment.
Participant milestones
| Measure |
Cediranib 45 mg Fed
Part A: Cediranib 45 mg Fed State
|
Cediranib 45 mg Fasted
Part A: Cediranib 45 mg Fasted State
|
Cediranib 45 mg Fixed Dose
Part B: Cediranib 45 mg Fixed Dose
|
Cediranib 30 to 90 mg Dose Escalation
Part B: Cediranib Dose Escalation
|
|---|---|---|---|---|
|
Part A
STARTED
|
23
|
22
|
0
|
0
|
|
Part A
COMPLETED
|
18
|
16
|
0
|
0
|
|
Part A
NOT COMPLETED
|
5
|
6
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
16
|
31
|
|
Part B
COMPLETED
|
0
|
0
|
5
|
14
|
|
Part B
NOT COMPLETED
|
0
|
0
|
11
|
17
|
Reasons for withdrawal
| Measure |
Cediranib 45 mg Fed
Part A: Cediranib 45 mg Fed State
|
Cediranib 45 mg Fasted
Part A: Cediranib 45 mg Fasted State
|
Cediranib 45 mg Fixed Dose
Part B: Cediranib 45 mg Fixed Dose
|
Cediranib 30 to 90 mg Dose Escalation
Part B: Cediranib Dose Escalation
|
|---|---|---|---|---|
|
Part A
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
|
Part A
Condition under investigation worsened
|
2
|
2
|
0
|
0
|
|
Part A
Incorrect enrol/entry crit not fulfilled
|
0
|
1
|
0
|
0
|
|
Part A
Partial bowel obstruction
|
1
|
0
|
0
|
0
|
|
Part A
Reaccumul. of ascites following drainage
|
0
|
1
|
0
|
0
|
|
Part A
Suspicion of second malignancy
|
0
|
1
|
0
|
0
|
|
Part A
QTC interval outwith elig. criteria
|
1
|
0
|
0
|
0
|
|
Part B
Death
|
0
|
0
|
1
|
2
|
|
Part B
Adverse Event
|
0
|
0
|
5
|
5
|
|
Part B
Withdrawal by Subject
|
0
|
0
|
3
|
1
|
|
Part B
Condition under investigation worsened
|
0
|
0
|
2
|
8
|
|
Part B
Development of study specific disc crit.
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Effect of Food Upon Pharmacokinetics of Single Oral Dose of Cediranib (AZD2171, Recentin™)
Baseline characteristics by cohort
| Measure |
Cediranib 45 mg Fed
n=23 Participants
Part A: Cediranib 45 mg Fed State
|
Cediranib 45 mg Fasted
n=22 Participants
Part A: Cediranib 45 mg Fasted State
|
Cediranib 45 mg Fixed Dose
n=16 Participants
Part B: Cediranib 45 mg Fixed Dose
|
Cediranib 30 to 90 mg Dose Escalation
n=31 Participants
Part B: Cediranib Dose Escalation
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
58.6 Years
STANDARD_DEVIATION 10.6 • n=93 Participants
|
51.2 Years
STANDARD_DEVIATION 14.8 • n=4 Participants
|
56.4 Years
STANDARD_DEVIATION 13.1 • n=27 Participants
|
56.0 Years
STANDARD_DEVIATION 13.5 • n=483 Participants
|
56.0 Years
STANDARD_DEVIATION 13.0 • n=36 Participants
|
|
Sex/Gender, Customized
Female, Part A
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
NA participants
n=27 Participants
|
NA participants
n=483 Participants
|
20 participants
n=36 Participants
|
|
Sex/Gender, Customized
Male, Part A
|
13 participants
n=93 Participants
|
12 participants
n=4 Participants
|
NA participants
n=27 Participants
|
NA participants
n=483 Participants
|
25 participants
n=36 Participants
|
|
Sex/Gender, Customized
Female, Part B
|
NA participants
n=93 Participants
|
NA participants
n=4 Participants
|
8 participants
n=27 Participants
|
12 participants
n=483 Participants
|
20 participants
n=36 Participants
|
|
Sex/Gender, Customized
Male, Part B
|
NA participants
n=93 Participants
|
NA participants
n=4 Participants
|
8 participants
n=27 Participants
|
19 participants
n=483 Participants
|
27 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Measurements were collected up to 168 hours (following single dosing).Area under plasma concentration-time curve from zero to infinity
Outcome measures
| Measure |
Cediranib 45 mg Fed
n=30 Participants
Part A: Cediranib 45 mg Fed State
|
Cediranib 45 mg Fasted
n=32 Participants
Part A: Cediranib 45 mg Fasted State
|
|---|---|---|
|
Part A: Area Under Plasma Concentration-time Curve (AUC)
|
1920 ng*h/mL
Interval 778.0 to 5760.0
|
2392 ng*h/mL
Interval 604.0 to 5730.0
|
PRIMARY outcome
Timeframe: Measurements were collected up to 168 hours (following single dosing).Maximum plasma drug concentration
Outcome measures
| Measure |
Cediranib 45 mg Fed
n=31 Participants
Part A: Cediranib 45 mg Fed State
|
Cediranib 45 mg Fasted
n=33 Participants
Part A: Cediranib 45 mg Fasted State
|
|---|---|---|
|
Part A: Maximum Plasma (Peak) Concentration (Cmax)
|
87.02 ng/mL
Interval 27.6 to 265.0
|
127.9 ng/mL
Interval 35.6 to 334.0
|
SECONDARY outcome
Timeframe: Measurements were collected up to 168 hours (following single dosing).Area under the curve from time 0 to the last measureable time point
Outcome measures
| Measure |
Cediranib 45 mg Fed
n=30 Participants
Part A: Cediranib 45 mg Fed State
|
Cediranib 45 mg Fasted
n=32 Participants
Part A: Cediranib 45 mg Fasted State
|
|---|---|---|
|
Part A: AUC (0-t)
|
1896 ng*h/mL
Interval 764.0 to 5700.0
|
2348 ng*h/mL
Interval 599.0 to 5290.0
|
SECONDARY outcome
Timeframe: Measurements were collected up to 168 hours (following single dosing).Time to reach peak or maximum concentration or maximum response
Outcome measures
| Measure |
Cediranib 45 mg Fed
n=31 Participants
Part A: Cediranib 45 mg Fed State
|
Cediranib 45 mg Fasted
n=33 Participants
Part A: Cediranib 45 mg Fasted State
|
|---|---|---|
|
Part A: Time to Peak or Maximum Concentration (Tmax)
|
4.59 hr
Interval 2.0 to 25.0
|
3.52 hr
Interval 2.0 to 6.1
|
SECONDARY outcome
Timeframe: Measurements were collected up to 168 hours (following single dosing).Terminal phase half-life
Outcome measures
| Measure |
Cediranib 45 mg Fed
n=30 Participants
Part A: Cediranib 45 mg Fed State
|
Cediranib 45 mg Fasted
n=32 Participants
Part A: Cediranib 45 mg Fasted State
|
|---|---|---|
|
Part A: Terminal Phase Half-life (t1/2λz)
|
23.99 hr
Interval 12.1 to 37.5
|
24.72 hr
Interval 10.2 to 60.2
|
SECONDARY outcome
Timeframe: Measurements were collected up to 168 hours (following single dosing).Apparent total body clearance of drug from plasma
Outcome measures
| Measure |
Cediranib 45 mg Fed
n=30 Participants
Part A: Cediranib 45 mg Fed State
|
Cediranib 45 mg Fasted
n=32 Participants
Part A: Cediranib 45 mg Fasted State
|
|---|---|---|
|
Part A: Apparent Total Body Clearance (CL/F)
|
23.44 L/h
Interval 7.81 to 57.8
|
18.81 L/h
Interval 7.85 to 74.5
|
SECONDARY outcome
Timeframe: Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation.Population: ITT (intention-to-treat ) patients with baseline RECIST data
Evaluation of target lesions Complete Response(CR)Disappearance of all target lesions Partial Response(PR) At least a 30% decrease in the sum of LD(longest diameter)of target lesions taking as reference the baseline sum LD.Progressive Disease(PD).At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded(either at baseline or at previous assessment since treatment began).Stable Disease(SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Note: Appearance of new lesions only counts towards the overall visit response,not towards the response of target or non-target lesions. Evaluation of non-target lesions Complete Response(CR)Disappearance of all non-target lesions Non-Complete Response(non-CR/Non-Progression\[non-PD\])Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.Progression(PD)Unequivocal progression of existing non-target lesions
Outcome measures
| Measure |
Cediranib 45 mg Fed
n=15 Participants
Part A: Cediranib 45 mg Fed State
|
Cediranib 45 mg Fasted
n=29 Participants
Part A: Cediranib 45 mg Fasted State
|
|---|---|---|
|
Part B: Best Overall Response Rate (ORR)
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Number of days from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.Population: ITT (intention-to-treat ) patients with baseline RECIST data.One patient was randomized and had baseline RECIST assessments, but did not have any further RECIST assessments. Therefore they were censored at baseline, meaning the lowest value in the range was set to zero.
Target lesions: Progressive Disease (PD) At least a 20% increase in the sum of LD (longest diameter)of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began). Non target lesions: Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Cediranib 45 mg Fed
n=15 Participants
Part A: Cediranib 45 mg Fed State
|
Cediranib 45 mg Fasted
n=29 Participants
Part A: Cediranib 45 mg Fasted State
|
|---|---|---|
|
Part B: Progression-free Survival (PFS)
|
135 Days
Interval 39.0 to 314.0
|
139 Days
Interval 0.0 to 454.0
|
Adverse Events
Cediranib 45 mg Part A
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
Cediranib 45 mg Fixed Dose
Serious events: 9 serious events
Other events: 16 other events
Deaths: 0 deaths
Cediranib 30 - 90 mg Dose Escalation
Serious events: 20 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cediranib 45 mg Part A
n=39 participants at risk
Part A: Cediranib 45 mg
|
Cediranib 45 mg Fixed Dose
n=16 participants at risk
Part B: Cediranib 45 mg Fixed Dose
|
Cediranib 30 - 90 mg Dose Escalation
n=31 participants at risk
Cediranib 30 - 90 mg Dose Escalation
|
|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
2.6%
1/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/39
|
12.5%
2/16
|
9.7%
3/31
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/39
|
6.2%
1/16
|
9.7%
3/31
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/39
|
0.00%
0/16
|
9.7%
3/31
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
2.6%
1/39
|
0.00%
0/16
|
0.00%
0/31
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Gastrointestinal disorders
Gastric Perforation
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
General disorders
Non-Cardiac Chest Pain
|
2.6%
1/39
|
0.00%
0/16
|
0.00%
0/31
|
|
General disorders
Pain
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
General disorders
Pyrexia
|
0.00%
0/39
|
6.2%
1/16
|
3.2%
1/31
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Infections and infestations
Central Line Infection
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Infections and infestations
Clostridial Infection
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Infections and infestations
Sepsis
|
0.00%
0/39
|
6.2%
1/16
|
3.2%
1/31
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Infections and infestations
Viral Labyrinthitis
|
2.6%
1/39
|
0.00%
0/16
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Tracheostomy Malfunction
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/39
|
6.2%
1/16
|
3.2%
1/31
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial Tumour Haemorrhage
|
2.6%
1/39
|
0.00%
0/16
|
0.00%
0/31
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Renal and urinary disorders
Renal Disorder
|
2.6%
1/39
|
0.00%
0/16
|
0.00%
0/31
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.6%
1/39
|
0.00%
0/16
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Vascular disorders
Hypertension
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
Other adverse events
| Measure |
Cediranib 45 mg Part A
n=39 participants at risk
Part A: Cediranib 45 mg
|
Cediranib 45 mg Fixed Dose
n=16 participants at risk
Part B: Cediranib 45 mg Fixed Dose
|
Cediranib 30 - 90 mg Dose Escalation
n=31 participants at risk
Cediranib 30 - 90 mg Dose Escalation
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/39
|
12.5%
2/16
|
9.7%
3/31
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/39
|
12.5%
2/16
|
3.2%
1/31
|
|
Blood and lymphatic system disorders
Haemoglobinaemia
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/39
|
6.2%
1/16
|
3.2%
1/31
|
|
Cardiac disorders
Bradycardia
|
5.1%
2/39
|
0.00%
0/16
|
3.2%
1/31
|
|
Cardiac disorders
Bundle Branch Block Right
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Ear and labyrinth disorders
Deafness Unilateral
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/39
|
6.2%
1/16
|
12.9%
4/31
|
|
Eye disorders
Dry Eye
|
0.00%
0/39
|
12.5%
2/16
|
0.00%
0/31
|
|
Eye disorders
Visual Disturbance
|
0.00%
0/39
|
0.00%
0/16
|
6.5%
2/31
|
|
Gastrointestinal disorders
Diarrhoea
|
12.8%
5/39
|
81.2%
13/16
|
80.6%
25/31
|
|
Gastrointestinal disorders
Nausea
|
23.1%
9/39
|
68.8%
11/16
|
54.8%
17/31
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
4/39
|
62.5%
10/16
|
45.2%
14/31
|
|
Gastrointestinal disorders
Constipation
|
10.3%
4/39
|
62.5%
10/16
|
32.3%
10/31
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.6%
1/39
|
25.0%
4/16
|
29.0%
9/31
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/39
|
25.0%
4/16
|
29.0%
9/31
|
|
Gastrointestinal disorders
Dry Mouth
|
2.6%
1/39
|
6.2%
1/16
|
12.9%
4/31
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/39
|
18.8%
3/16
|
9.7%
3/31
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
5.1%
2/39
|
0.00%
0/16
|
0.00%
0/31
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.6%
1/39
|
6.2%
1/16
|
3.2%
1/31
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Gastrointestinal disorders
Lip Blister
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/39
|
6.2%
1/16
|
3.2%
1/31
|
|
Gastrointestinal disorders
Tongue Ulceration
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
General disorders
Fatigue
|
20.5%
8/39
|
31.2%
5/16
|
32.3%
10/31
|
|
General disorders
Oedema Peripheral
|
5.1%
2/39
|
6.2%
1/16
|
12.9%
4/31
|
|
General disorders
Pyrexia
|
0.00%
0/39
|
0.00%
0/16
|
6.5%
2/31
|
|
General disorders
Unevaluable Event
|
0.00%
0/39
|
0.00%
0/16
|
6.5%
2/31
|
|
General disorders
Malaise
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Infections and infestations
Oral Candidiasis
|
2.6%
1/39
|
6.2%
1/16
|
9.7%
3/31
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/39
|
6.2%
1/16
|
6.5%
2/31
|
|
Infections and infestations
Rhinitis
|
0.00%
0/39
|
12.5%
2/16
|
3.2%
1/31
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/39
|
12.5%
2/16
|
3.2%
1/31
|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Infections and infestations
Pneumonia
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/39
|
6.2%
1/16
|
3.2%
1/31
|
|
Infections and infestations
Vaginal Candidiasis
|
0.00%
0/39
|
6.2%
1/16
|
3.2%
1/31
|
|
Infections and infestations
Viral Infection
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Injury, poisoning and procedural complications
Contusion
|
2.6%
1/39
|
0.00%
0/16
|
6.5%
2/31
|
|
Investigations
Weight Decreased
|
2.6%
1/39
|
12.5%
2/16
|
25.8%
8/31
|
|
Investigations
Blood Thyroid Stimulating Hormone Increased
|
0.00%
0/39
|
12.5%
2/16
|
22.6%
7/31
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/39
|
6.2%
1/16
|
6.5%
2/31
|
|
Investigations
Blood Pressure Increased
|
5.1%
2/39
|
0.00%
0/16
|
0.00%
0/31
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/39
|
6.2%
1/16
|
3.2%
1/31
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/39
|
6.2%
1/16
|
3.2%
1/31
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
5.1%
2/39
|
25.0%
4/16
|
25.8%
8/31
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
3/39
|
18.8%
3/16
|
19.4%
6/31
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.6%
1/39
|
6.2%
1/16
|
19.4%
6/31
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
1/39
|
12.5%
2/16
|
12.9%
4/31
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/39
|
0.00%
0/16
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/39
|
0.00%
0/16
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/39
|
0.00%
0/16
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
2.6%
1/39
|
0.00%
0/16
|
6.5%
2/31
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/39
|
6.2%
1/16
|
3.2%
1/31
|
|
Musculoskeletal and connective tissue disorders
Mobility Decreased
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.6%
1/39
|
6.2%
1/16
|
3.2%
1/31
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
2.6%
1/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/39
|
6.2%
1/16
|
3.2%
1/31
|
|
Nervous system disorders
Lethargy
|
20.5%
8/39
|
25.0%
4/16
|
22.6%
7/31
|
|
Nervous system disorders
Dizziness
|
5.1%
2/39
|
6.2%
1/16
|
19.4%
6/31
|
|
Nervous system disorders
Headache
|
5.1%
2/39
|
31.2%
5/16
|
16.1%
5/31
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/39
|
6.2%
1/16
|
3.2%
1/31
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Nervous system disorders
Sciatica
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Nervous system disorders
Tremor
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Psychiatric disorders
Depression
|
0.00%
0/39
|
6.2%
1/16
|
9.7%
3/31
|
|
Psychiatric disorders
Anxiety
|
5.1%
2/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Psychiatric disorders
Depressed Mood
|
5.1%
2/39
|
0.00%
0/16
|
0.00%
0/31
|
|
Psychiatric disorders
Insomnia
|
2.6%
1/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/39
|
6.2%
1/16
|
6.5%
2/31
|
|
Renal and urinary disorders
Urinary Tract Disorder
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Renal and urinary disorders
Urine Odour Abnormal
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.1%
2/39
|
25.0%
4/16
|
22.6%
7/31
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
1/39
|
12.5%
2/16
|
9.7%
3/31
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/39
|
18.8%
3/16
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
1/39
|
12.5%
2/16
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/39
|
0.00%
0/16
|
6.5%
2/31
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/39
|
12.5%
2/16
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/39
|
18.8%
3/16
|
3.2%
1/31
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/39
|
0.00%
0/16
|
6.5%
2/31
|
|
Skin and subcutaneous tissue disorders
Skin Induration
|
0.00%
0/39
|
0.00%
0/16
|
6.5%
2/31
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Vascular disorders
Hypertension
|
23.1%
9/39
|
62.5%
10/16
|
74.2%
23/31
|
|
Vascular disorders
Hypotension
|
0.00%
0/39
|
6.2%
1/16
|
0.00%
0/31
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/39
|
6.2%
1/16
|
3.2%
1/31
|
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