An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

• Sponsor: Cougar Biotechnology, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00474383
• Collaborator: (none)
• Enrollment: 47
• Locations: 3
• Arm: 1
• Duration (Months): 57
• Patients Per Site: 15.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer (a disease in which cells in the prostate gland [a gland in the male reproductive system found below the bladder and in front of the rectum] become abnormal and start to grow uncontrollably, forming tumors) who have failed taxane (docetaxel)-based chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Prostate Neoplasms	Drug: Abiraterone acetate; Drug: Glucocorticoid	Phase 2

Detailed Description

This is an open-label (all people know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in participants with cancer who have failed taxane (docetaxel)-based chemotherapy. Abiraterone acetate 1000 milligram (mg) tablet or capsule will be administered orally (by mouth), once daily after an overnight fast until disease progression, lack of disease response after six 28-day cycles of treatment, or when unacceptable toxicity is encountered. Participants will be treated for up to 12 cycles. All participants will receive a concurrent low-dose glucocorticoid (such as prednisone 5 mg tablet twice daily/prednisolone 0.5 mg tablet once daily). Treatment will be continued in responding participants until death, or disease progression, or end of the study (which is Week 148). Efficacy will primarily be assessed through prostate specific antigen response according to Prostate Specific Antigen Working Group (PSAWG) criteria. Participants' safety will be monitored throughout the study. Participants who have completed 12 cycles of abiraterone acetate treatment, and continue to receive clinical benefit from such treatment, will be eligible to enter the extension study. Participants who enter the extension study will continue taking abiraterone acetate at the dose they were receiving at the end of the main study together with low-dose glucocorticoid. Efficacy and safety will be monitored throughout the extension study. Study treatment will end when the patient dies, is lost to follow-up, withdraws informed consent, experiences sustained side-effects, has disease progression, or the sponsor discontinues the extension study. After the end of study visit is completed for the extension study, participants will be followed every 12 weeks for survival for up to 3 years following entry into the extension study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Abiraterone acetate Abiraterone acetate 1000 milligram (mg) tablet or capsule will be administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.

Drug: Abiraterone acetate; Abiraterone acetate 1000 milligram (mg) capsule or tablet will be administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study.; Drug: Glucocorticoid; Prednisone/prednisolone 5 mg tablet orally twice daily/dexamethasone 0.5 mg tablet orally once daily continuously in 28-day cycle up to disease progression, death, or end of study.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12 [Baseline, Week 12]

   The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.

Secondary Outcome Measures

1. Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response [Baseline up to Week 12]

   The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.

2. Percentage of Participants With Confirmed Objective Tumor Response as Per Response Evaluation Criteria in Solid Tumors (RECIST) [Baseline until first documented disease progression or end of study visit (Week 148; assessed on Day 1 of Cycle 4, 7, 10, and thereafter Day 1 of each cycle)]

   The objective tumor response was defined as the percentage of participants achieving a complete (CR) or partial response (PR) on tumor response assessed as per RECIST. The CR was disappearance of all lesions. The PR was at least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Baseline sum LD.

3. Time to PSA Progression [Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)]

   The time to PSA progression was the interval from the date of the first dose of abiraterone acetate to the date of PSA progression as defined by the PSAWG criteria. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.

4. Duration of PSA Response [Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)]

   Duration of PSA response was the time between the date of first PSA response (greater than or equal to 50 percent decline from Baseline) and the date of PSA progression as defined by the PSAWG. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.

5. Progression Free Survival Time [Baseline until first documented disease progression or death or up to end of study (Week 148; assessed on Day 1 of each cycle)]

   Progression Free Survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death or date of progressive disease (PD) as assessed by RECIST criteria. PD was at least 20 percent increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

6. Overall Survival [Baseline until death, or end of study (Week 148)]

   Overall survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death.

7. Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148) [Baseline until first documented disease progression or up to end of study (Week 148; assessed on Day 1 of each cycle)]

   The ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction; 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percentage of waking hours; 3=capable of limited self-care, confined to bed or chair >50 percentage of waking hours; 4=completely disabled, not capable of any self-care, totally confined to bed or chair; and 5=dead.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma (cancer that begins in cells that line certain internal organs and that have secretory properties) of the prostate, but not with neuroendocrine differentiation or of small cell histology

• Before chemotherapy for prostate cancer with regimen(s) containing paclitaxel or docetaxel

• Documented prostate-specific antigen (PSA) progression according to PSA working group eligibility criteria with a PSA greater than 5 nanogram per milliliter (ng/mL)

• Ongoing androgen deprivation with serum testosterone level of less than 50 nanogram per deciliter (ng/dL)

• Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 2 (Karnofsky Performance Status greater than or equal 50 percentage)

Exclusion Criteria:

• Active or uncontrolled autoimmune disease that may require corticosteroid therapy

• Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection

• Uncontrolled hypertension

• Clinically significant heart disease as evidenced by a myocardial infarction in the past 12 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease (participants with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least 2 years before to enrollment and after consultation with a cardiologist to insure that the disease is stable)

• History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		San Francisco	California	United States
2		New York	New York	United States
3		Sutton		United Kingdom

Sponsors and Collaborators

• Cougar Biotechnology, Inc.

Investigators

• Study Director: Cougar Biotechnology, Inc. Clinical Trial, Cougar Biotechnology, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• NATIONAL CANCER INSTITUTE
• PROSTATE CANCER

Publications

None provided.

• Responsible Party: Cougar Biotechnology, Inc.
• ClinicalTrials.gov Identifier: NCT00474383
• Other Study ID Numbers: CR016915; COU-AA-003; COU-AA-003EXT; NCT01798615
• First Posted: May 16, 2007
• Last Update Posted: May 12, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Cougar Biotechnology, Inc.: Prostate neoplasms; CB7630; Abiraterone acetate; Glucocorticoid; Prednisone; Prednisolone
• Additional relevant MeSH terms: Prostatic Neoplasms; Abiraterone Acetate; Glucocorticoids

Study Results

Participant Flow

Recruitment Details	The 5 participants in the Extension Study received treatment until they experienced progressive disease.

Arm/Group Title	Abiraterone Acetate (Main Study)	Arbitarone Acetate (Extension)
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.	Participants who received abiraterone acetate 1000 milligram (mg) capsule or tablet orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily in Main study, continued the same treatment until disease progression, death, or end of study (Week 148).
Period Title: Main Study
STARTED	47	0
COMPLETED	11	0
NOT COMPLETED	36	0
Period Title: Main Study
STARTED	11	0
COMPLETED	5	0
NOT COMPLETED	6	0
Period Title: Main Study
STARTED	0	5
COMPLETED	0	0
NOT COMPLETED	0	5

Baseline Characteristics

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Overall Participants	47
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67 (8.42)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	47 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12
Description	The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The Intent-to-treat (ITT) population included all the participants who were enrolled into the study.

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Measure Participants	47
Number (95% Confidence Interval) [percentage of participants]	36.2 77%

2. Secondary Outcome

Title	Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response
Description	The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.
Time Frame	Baseline up to Week 12

Outcome Measure Data

Analysis Population Description

The Intent-to-treat (ITT) population included all the participants who were enrolled into the study.

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Measure Participants	47
Number (95% Confidence Interval) [percentage of participants]	44.7 95.1%

3. Secondary Outcome

Title	Percentage of Participants With Confirmed Objective Tumor Response as Per Response Evaluation Criteria in Solid Tumors (RECIST)
Description	The objective tumor response was defined as the percentage of participants achieving a complete (CR) or partial response (PR) on tumor response assessed as per RECIST. The CR was disappearance of all lesions. The PR was at least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Baseline sum LD.
Time Frame	Baseline until first documented disease progression or end of study visit (Week 148; assessed on Day 1 of Cycle 4, 7, 10, and thereafter Day 1 of each cycle)

Outcome Measure Data

Analysis Population Description

The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline.

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Measure Participants	23
Number (95% Confidence Interval) [percentage of participants]	26.1 55.5%

4. Secondary Outcome

Title	Time to PSA Progression
Description	The time to PSA progression was the interval from the date of the first dose of abiraterone acetate to the date of PSA progression as defined by the PSAWG criteria. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.
Time Frame	Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)

Outcome Measure Data

Analysis Population Description

The ITT population included all the participants who were enrolled into the study.

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Measure Participants	47
Median (95% Confidence Interval) [days]	169

5. Secondary Outcome

Title	Duration of PSA Response
Description	Duration of PSA response was the time between the date of first PSA response (greater than or equal to 50 percent decline from Baseline) and the date of PSA progression as defined by the PSAWG. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.
Time Frame	Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)

Outcome Measure Data

Analysis Population Description

The ITT population included all the participants who were enrolled into the study.

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Measure Participants	47
Median (95% Confidence Interval) [days]	169

6. Secondary Outcome

Title	Progression Free Survival Time
Description	Progression Free Survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death or date of progressive disease (PD) as assessed by RECIST criteria. PD was at least 20 percent increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame	Baseline until first documented disease progression or death or up to end of study (Week 148; assessed on Day 1 of each cycle)

Outcome Measure Data

Analysis Population Description

The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline.

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Measure Participants	23
Median (95% Confidence Interval) [days]	457

7. Secondary Outcome

Title	Overall Survival
Description	Overall survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death.
Time Frame	Baseline until death, or end of study (Week 148)

Outcome Measure Data

Analysis Population Description

The ITT population included all the participants who were enrolled into the study.

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Measure Participants	47
Median (95% Confidence Interval) [days]	380

8. Secondary Outcome

Title	Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148)
Description	The ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction; 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percentage of waking hours; 3=capable of limited self-care, confined to bed or chair >50 percentage of waking hours; 4=completely disabled, not capable of any self-care, totally confined to bed or chair; and 5=dead.
Time Frame	Baseline until first documented disease progression or up to end of study (Week 148; assessed on Day 1 of each cycle)

Outcome Measure Data

Analysis Population Description

The ITT population included all the participants who were enrolled into the study.

Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Measure Participants	47
Baseline, ECOG 0	16 34%
Baseline, ECOG 1	27 57.4%
Baseline, ECOG 2	4 8.5%
Best Post-Baseline. ECOG 0	25 53.2%
Best Post-Baseline. ECOG 1	19 40.4%
Best Post-Baseline. ECOG 2	3 6.4%

Adverse Events

Time Frame	From the first dose of study medication until 30 days after the last dose of study medication
Arm/Group Title	Abiraterone Acetate
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
All Cause Mortality
	Abiraterone Acetate
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Abiraterone Acetate
	Affected / at Risk (%)	# Events
Total	27/47 (57.4%)
Blood and lymphatic system disorders
Anaemia	5/47 (10.6%)
Disseminated intravascular coagulation	1/47 (2.1%)
Thrombocytopenia	1/47 (2.1%)
Cardiac disorders
Left ventricular dysfunction	1/47 (2.1%)
Myocardial infarction	1/47 (2.1%)
Endocrine disorders
Adrenal insufficiency	2/47 (4.3%)
Gastrointestinal disorders
Abdominal discomfort	1/47 (2.1%)
Ascites	1/47 (2.1%)
Constipation	2/47 (4.3%)
Diarrhoea	2/47 (4.3%)
Nausea	4/47 (8.5%)
Vomiting	3/47 (6.4%)
General disorders
Asthenia	1/47 (2.1%)
Disease progression	1/47 (2.1%)
Fatigue	1/47 (2.1%)
Influenza like illness	1/47 (2.1%)
Pitting oedema	1/47 (2.1%)
Pyrexia	1/47 (2.1%)
Infections and infestations
Bronchopneumonia	1/47 (2.1%)
Sepsis	2/47 (4.3%)
Urinary tract infection	1/47 (2.1%)
Urosepsis	1/47 (2.1%)
Injury, poisoning and procedural complications
Fall	1/47 (2.1%)
Femur fracture	2/47 (4.3%)
Humerus fracture	1/47 (2.1%)
Therapeutic agent toxicity	1/47 (2.1%)
Investigations
Transaminases increased	1/47 (2.1%)
Metabolism and nutrition disorders
Anorexia	3/47 (6.4%)
Dehydration	1/47 (2.1%)
Fluid retention	1/47 (2.1%)
Hypokalaemia	1/47 (2.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/47 (2.1%)
Back pain	2/47 (4.3%)
Bone pain	1/47 (2.1%)
Groin pain	2/47 (4.3%)
Muscular weakness	1/47 (2.1%)
Pathological fracture	1/47 (2.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum	1/47 (2.1%)
Nervous system disorders
Peripheral motor neuropathy	1/47 (2.1%)
Spinal cord compression	2/47 (4.3%)
Syncope	1/47 (2.1%)
Renal and urinary disorders
Renal failure	1/47 (2.1%)
Reproductive system and breast disorders
Pelvic pain	1/47 (2.1%)
Respiratory, thoracic and mediastinal disorders
Aspiration	1/47 (2.1%)
Dyspnoea	1/47 (2.1%)
Pleural effusion	1/47 (2.1%)
Pneumonitis	1/47 (2.1%)
Vascular disorders
Hypertension	1/47 (2.1%)
Other (Not Including Serious) Adverse Events
	Abiraterone Acetate
	Affected / at Risk (%)	# Events
Total	46/47 (97.9%)
Blood and lymphatic system disorders
Anaemia	9/47 (19.1%)
Neutropenia	3/47 (6.4%)
Thrombocytopenia	3/47 (6.4%)
Gastrointestinal disorders
Constipation	11/47 (23.4%)
Diarrhoea	11/47 (23.4%)
Nausea	10/47 (21.3%)
Vomiting	10/47 (21.3%)
General disorders
Fatigue	25/47 (53.2%)
Oedema peripheral	13/47 (27.7%)
Infections and infestations
Cellulitis	4/47 (8.5%)
Nasopharyngitis	4/47 (8.5%)
Tooth infection	3/47 (6.4%)
Urinary tract infection	8/47 (17%)
Injury, poisoning and procedural complications
Contusion	3/47 (6.4%)
Investigations
Alanine aminotransferase increased	3/47 (6.4%)
Blood albumin decreased	4/47 (8.5%)
Blood creatine increased	3/47 (6.4%)
Blood sodium increased	3/47 (6.4%)
Weight decreased	3/47 (6.4%)
Weight increased	6/47 (12.8%)
White blood cell count decreased	3/47 (6.4%)
Metabolism and nutrition disorders
Anorexia	13/47 (27.7%)
Decreased appetite	4/47 (8.5%)
Hyperglycaemia	7/47 (14.9%)
Hypokalaemia	29/47 (61.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	14/47 (29.8%)
Back pain	9/47 (19.1%)
Bone pain	9/47 (19.1%)
Groin pain	4/47 (8.5%)
Muscular weakness	5/47 (10.6%)
Musculoskeletal chest pain	4/47 (8.5%)
Musculoskeletal pain	9/47 (19.1%)
Pain in extremity	6/47 (12.8%)
Nervous system disorders
Dizziness	5/47 (10.6%)
Headache	6/47 (12.8%)
Hypoaesthesia	3/47 (6.4%)
Paraesthesia	4/47 (8.5%)
Psychiatric disorders
Insomnia	4/47 (8.5%)
Renal and urinary disorders
Haematuria	3/47 (6.4%)
Respiratory, thoracic and mediastinal disorders
Cough	7/47 (14.9%)
Dyspnoea	7/47 (14.9%)
Productive cough	5/47 (10.6%)
Vascular disorders
Hypertension	10/47 (21.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.