Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer
Sponsor
Sunesis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00408603
Collaborator
(none)
183
20
1
41.6
9.2
0.2
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the objective response rate, safety and identify potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin injection given on a 28-day cycle.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.
Study Design
Study Type:
Interventional
Actual Enrollment
:
183 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Open-Label, Multicenter Study of SNS-595 Injection in Patients With Platinum-Resistant Ovarian Cancer
Actual Study Start Date
:
Dec 20, 2006
Actual Primary Completion Date
:
Jun 9, 2010
Actual Study Completion Date
:
Jun 9, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: All study patients All patients will receive voreloxin injection |
Drug: Voreloxin Injection
All patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles. Subsequent levels are of 60 mg/m2 or 75 mg/m2 every 28 days up to 6 cycles if safety acceptable.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria [GOG-RECIST assessment obtained on cycle2, 4 and 6 Day 21for patients treated with 48 mg/m2 SNS-595 and Day 28 for patients treated with 60 mg/m2, through 28 (±14) days afte the last treatment at the end of safety follow up period]
Response rate was calculated per investigator's tumor assessment based on GOG-RECIST, which includes radiographic imaging, physical examination results, and CA-125 levels. No independent review of CT scans (lesion assessments) was performed. CR: disappearance of all target and nontarget lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. PR is >= 30% decrease in the sum of LD of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required.
Secondary Outcome Measures
- Progression-free Survival (PFS) Using Kaplan-Meier Methods [From the first teratment of Vosaroxin to the end of Cycle 6 or 28 days after the last treatment at the end of safety follow up period if continued in the extended treatment period]
PFS is the the time between the date the patient first received Vosaroxin and the earliest date of disease progression. For patients who experienced disease progression, the date of disease progression will be the earliest date on which disease progression is indicated based on the rules. For patients who died with no indication of disease progression, the date of death will be the earliest date on which death is documented based on the rules. For patients who have no indication of disease progression or death, the censoring date will be the Date of Confirmed Contact from the last Survival Follow-Up CRF, or if not in survival follow-up, then the Assessment Date from the last GOG-RECIST CRF, or if no response assessment available, Date of Last Visit / Contact from Extended Treatment Completion CRF if in extended treatment, or from Cycle 6 Completion / Early Termination CRF if not in extended treatment.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically or cytologically documented epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
-
Completed at least one Platinum Based Therapy (PBT) regimen (carboplatin, cisplatin, or another organoplatinum compound).
-
Evidence of platinum-resistant disease, relapse/progression within 6 months of the completion of PBT, or intolerant to PBT (inability to receive PBT due to hypersensitivity reactions to platinum)
-
Patients with primary platinum-resistant disease are allowed to receive no more than one nonplatinum cytotoxic regimen and no more than one noncytotoxic regimen for the management of recurrent or persistent disease after the development of primary platinum-resistance.
-
Measurable disease per GOG-RECIST criteria
-
GOG Performance Status of 0 or 1
Exclusion Criteria:
-
Radiotherapy, chemotherapy, and hormonal, cytokine, or targeted therapy, within 3 weeks (nitrosurea or mitomycin C within 6 weeks) prior to the anticipated first day of treatment.
-
Monoclonal antibody therapy within 4 weeks prior to clinical study entry
-
Unresolved or impending bowel obstruction
-
Other active malignancies or other malignancies within the last 12 months except nonmelanoma skin cancer or cervical intraepithelial neoplasia
-
Prior radiotherapy to more than 25% of the marrow space
-
Requiring hemodialysis or peritoneal dialysis
-
Myocardial infarction or cerebrovascular accident/transient ischemic attack within the 6 months prior to the anticipated first day of treatment
-
Thromboembolic event (deep vein thrombosis [DVT] or pulmonary embolus [PE]) within 28 days prior to the anticipated first day of treatment
-
History of active CNS metastases
-
Any other medical, psychological, or social condition that would contraindicate the patient's participation in the clinical study due to safety or compliance with clinical study procedures.
Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if you meet all study criteria.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Premiere Oncology of Arizona | Scottsdale | Arizona | United States | 85260 |
| 2 | Gynecologic Oncology Associates | Newport Beach | California | United States | 92663 |
| 3 | Sharp Clinical Oncology Research | San Diego | California | United States | 92123 |
| 4 | Stanford University | Stanford | California | United States | 94305 |
| 5 | Medstar Research Institute at Washington Hospital Center | Washington, D.C. | District of Columbia | United States | 10010 |
| 6 | Oncology Specialists, S.C. at Luthern General Advanced Care Center | Park Ridge | Illinois | United States | 60068 |
| 7 | Louisville Oncology Clinical Research Program | Louisville | Kentucky | United States | 40202 |
| 8 | The Harry and Jeanette Weinberg Institute at Franklin Square | Baltimore | Maryland | United States | 21237 |
| 9 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 10 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 11 | Memorial Sloan Kettering Cancer Center (MSKCC) | New York | New York | United States | 10021 |
| 12 | Kaiser Permanente NW Region | Portland | Oregon | United States | 97227 |
| 13 | University of Pittsburgh Medical Center at Magee-Womens Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
| 14 | Hall and Martin, MD's, P.C. | Knoxville | Tennessee | United States | 37920 |
| 15 | Tom Baker Cancer Centre | Calgary | Alberta | Canada | T2N 4N2 |
| 16 | BC Cancer Agency at Centre for Southern Interior | Kelowna | British Columbia | Canada | V1Y 5L3 |
| 17 | BC Cancer Agency at Fraser Valley Centre | Surrey | British Columbia | Canada | V3V 1Z2 |
| 18 | BC Cancer Agency at Vancouver | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 19 | BC Cancer Agency - Vancouver Island Centre | Victoria | British Columbia | Canada | V8R 6V5 |
| 20 | Juravinski Cancer Centre Department of Oncology | Hamilton | Ontario | Canada | L8V 5C2 |
Sponsors and Collaborators
- Sunesis Pharmaceuticals
Investigators
- Study Director: Sunesis Medical Monitor, MD, Sunesis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00408603
Other Study ID Numbers:
- SPO-0010
First Posted:
Dec 7, 2006
Last Update Posted:
Jul 27, 2017
Last Verified:
Jun 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sunesis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Stage 48 mg/m2 | Stage 60 mg/m2 | Stage 75 mg/m2 |
|---|---|---|---|
| Arm/Group Description | All Stage 1 patients will receive voreloxin injection Voreloxin Injection: All Stage 1 patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles. | Following safety of 48 mg/m2 group, next Stagel is 60mg/m2 at 28 day periods up to 6 cycles. | Following safety of 60 mg/m2 group, next Stage is 75 mg/m2 at 28 day periods up to 6 cycles. |
| Period Title: Overall Study | |||
| STARTED | 69 | 39 | 75 |
| COMPLETED | 65 | 37 | 35 |
| NOT COMPLETED | 4 | 2 | 40 |
Baseline Characteristics
| Arm/Group Title | 48 mg/m2 | 60 mg/m2 | 75 mg/m2 | Total |
|---|---|---|---|---|
| Arm/Group Description | 48 mg/m2 every 21 days | 60 mg/m2 every 28 days | 75 mg/m2 every 28 days | Total of all reporting groups |
| Overall Participants | 65 | 37 | 35 | 137 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
60
(9.87)
|
62.7
(10.51)
|
57.6
(12.13)
|
60.1
(10.74)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
65
100%
|
37
100%
|
35
100%
|
137
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
65
100%
|
37
100%
|
35
100%
|
137
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| Asian |
5
7.7%
|
1
2.7%
|
2
5.7%
|
8
5.8%
|
| Black or African |
4
6.2%
|
1
2.7%
|
1
2.9%
|
6
4.4%
|
| White or Caucasian |
56
86.2%
|
35
94.6%
|
31
88.6%
|
122
89.1%
|
| Other, Philippines |
0
0%
|
0
0%
|
1
2.9%
|
1
0.7%
|
| Height (cm) (cm) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [cm] |
162.4
(6.75)
|
161.9
(7.01)
|
163.9
(7.01)
|
162.7
(6.88)
|
| Weight (kg) (kg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg] |
75.1
(17.21)
|
71.2
(20.52)
|
69.9
(15.39)
|
72.7
(17.76)
|
| BSA (m2) (m2) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [m2] |
1.8
(0.2)
|
1.7
(0.24)
|
1.8
(0.2)
|
1.8
(0.21)
|
Outcome Measures
| Title | Overall Response Rate (CR+PR) Per Investigator Assessment Based on GOG-RECIST Criteria |
|---|---|
| Description | Response rate was calculated per investigator's tumor assessment based on GOG-RECIST, which includes radiographic imaging, physical examination results, and CA-125 levels. No independent review of CT scans (lesion assessments) was performed. CR: disappearance of all target and nontarget lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. PR is >= 30% decrease in the sum of LD of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. |
| Time Frame | GOG-RECIST assessment obtained on cycle2, 4 and 6 Day 21for patients treated with 48 mg/m2 SNS-595 and Day 28 for patients treated with 60 mg/m2, through 28 (±14) days afte the last treatment at the end of safety follow up period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population which included all patients who received any amount of vosaroxin |
| Arm/Group Title | 48 mg/m2 | 60 mg/m2 | 75 mg/m2 | Total |
|---|---|---|---|---|
| Arm/Group Description | 48 mg/m2 every 21 days | 60 mg/m2 every 28 days | 75 mg/m2 every 28 days | Overall |
| Measure Participants | 65 | 37 | 35 | 137 |
| Count of Participants [Participants] |
7
10.8%
|
4
10.8%
|
3
8.6%
|
14
10.2%
|
| Title | Progression-free Survival (PFS) Using Kaplan-Meier Methods |
|---|---|
| Description | PFS is the the time between the date the patient first received Vosaroxin and the earliest date of disease progression. For patients who experienced disease progression, the date of disease progression will be the earliest date on which disease progression is indicated based on the rules. For patients who died with no indication of disease progression, the date of death will be the earliest date on which death is documented based on the rules. For patients who have no indication of disease progression or death, the censoring date will be the Date of Confirmed Contact from the last Survival Follow-Up CRF, or if not in survival follow-up, then the Assessment Date from the last GOG-RECIST CRF, or if no response assessment available, Date of Last Visit / Contact from Extended Treatment Completion CRF if in extended treatment, or from Cycle 6 Completion / Early Termination CRF if not in extended treatment. |
| Time Frame | From the first teratment of Vosaroxin to the end of Cycle 6 or 28 days after the last treatment at the end of safety follow up period if continued in the extended treatment period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population which included all patients who received any amount of vosaroxin |
| Arm/Group Title | 48 mg/m2 | 60 mg/m2 | 75 mg/m2 | Total |
|---|---|---|---|---|
| Arm/Group Description | 48 mg/m2 every 21 days | 60 mg/m2 every 28 days | 75 mg/m2 every 28 days | Overall |
| Measure Participants | 65 | 37 | 35 | 137 |
| Median (95% Confidence Interval) [Days] |
83
|
61
|
103
|
81
|
Adverse Events
| Time Frame | Approximately 50% of patients were assessed for AEs for 112 days or less and the other approximate 50% were assessed for 112 to 700 days. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | 48 mg/m2 | 60 mg/m2 | 75 mg/m2 | Total | ||||
| Arm/Group Description | 48 mg/m2 every 21 days | 60 mg/m2 every 28 days | 75 mg/m2 every 28 days | Overall | ||||
All Cause Mortality |
||||||||
| 48 mg/m2 | 60 mg/m2 | 75 mg/m2 | Total | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/65 (10.8%) | 2/37 (5.4%) | 3/35 (8.6%) | 11/137 (8%) | ||||
Serious Adverse Events |
||||||||
| 48 mg/m2 | 60 mg/m2 | 75 mg/m2 | Total | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/65 (23.1%) | 9/37 (24.3%) | 14/35 (40%) | 38/137 (27.7%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 2/65 (3.1%) | 1/37 (2.7%) | 2/35 (5.7%) | 5/137 (3.6%) | ||||
| Disseminated intravascular coagulation | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Febrile neutropenia | 3/65 (4.6%) | 2/37 (5.4%) | 10/35 (28.6%) | 15/137 (10.9%) | ||||
| Leukopenia | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Neutropenia | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Pancytopenia | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Thrombocytopenia | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Gastrointestinal disorders | ||||||||
| Diarrhoea | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Gastrointestinal haemorrhage | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Intestinal obstruction | 0/65 (0%) | 2/37 (5.4%) | 1/35 (2.9%) | 3/137 (2.2%) | ||||
| Nausea | 1/65 (1.5%) | 2/37 (5.4%) | 1/35 (2.9%) | 4/137 (2.9%) | ||||
| Small intestinal obstruction | 1/65 (1.5%) | 1/37 (2.7%) | 2/35 (5.7%) | 4/137 (2.9%) | ||||
| Vomiting | 2/65 (3.1%) | 1/37 (2.7%) | 1/35 (2.9%) | 4/137 (2.9%) | ||||
| General disorders | ||||||||
| Fatigue | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Pyrexia | 2/65 (3.1%) | 1/37 (2.7%) | 0/35 (0%) | 3/137 (2.2%) | ||||
| Infections and infestations | ||||||||
| Abdominal abscess | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Abdominal wall infection | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Bacillus infection | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Bacteraemia | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Bacterial infection | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Catheter bacteraemia | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Cellulitis | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Cystitis | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Diverticulitis | 2/65 (3.1%) | 0/37 (0%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Gastroenteritis | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Neutropenic sepsis | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Urinary tract infection bacterial | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Wound infection | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Dehydration | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Failure to thrive | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Hypokalaemia | 0/65 (0%) | 1/37 (2.7%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Myelodysplastic syndrome | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Nervous system disorders | ||||||||
| Brain stem syndrome | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Renal and urinary disorders | ||||||||
| Nephropathy | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Renal disorder | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Pulmonary embolism | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Vascular disorders | ||||||||
| Deep vein thrombosis | 1/65 (1.5%) | 1/37 (2.7%) | 0/35 (0%) | 2/137 (1.5%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| 48 mg/m2 | 60 mg/m2 | 75 mg/m2 | Total | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 63/65 (96.9%) | 37/37 (100%) | 35/35 (100%) | 135/137 (98.5%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 14/65 (21.5%) | 14/37 (37.8%) | 13/35 (37.1%) | 41/137 (29.9%) | ||||
| Febrile neutropenia | 3/65 (4.6%) | 3/37 (8.1%) | 1/35 (2.9%) | 7/137 (5.1%) | ||||
| Leukopenia | 4/65 (6.2%) | 2/37 (5.4%) | 2/35 (5.7%) | 8/137 (5.8%) | ||||
| Lymph node pain | 1/65 (1.5%) | 0/37 (0%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Lymphadenopathy | 1/65 (1.5%) | 1/37 (2.7%) | 1/35 (2.9%) | 3/137 (2.2%) | ||||
| Neutropenia | 21/65 (32.3%) | 8/37 (21.6%) | 18/35 (51.4%) | 47/137 (34.3%) | ||||
| Pancytopenia | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Thrombocytopenia | 0/65 (0%) | 0/37 (0%) | 4/35 (11.4%) | 4/137 (2.9%) | ||||
| Cardiac disorders | ||||||||
| Atrial fibrillation | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Mitral valve incompetence | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Palpitations | 1/65 (1.5%) | 1/37 (2.7%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Pericardial effusion | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Sinus tachycardia | 1/65 (1.5%) | 1/37 (2.7%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Tachycardia | 1/65 (1.5%) | 2/37 (5.4%) | 2/35 (5.7%) | 5/137 (3.6%) | ||||
| Tricuspid valve incompetence | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Ear and labyrinth disorders | ||||||||
| Ear pain | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Vertigo | 3/65 (4.6%) | 1/37 (2.7%) | 0/35 (0%) | 4/137 (2.9%) | ||||
| Eye disorders | ||||||||
| Blepharospasm | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Dark circles under eyes | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Dry eye | 1/65 (1.5%) | 0/37 (0%) | 2/35 (5.7%) | 3/137 (2.2%) | ||||
| Lacrimation increased | 1/65 (1.5%) | 1/37 (2.7%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Ocular hyperaemia | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Photophobia | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Photopsia | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Vision blurred | 3/65 (4.6%) | 1/37 (2.7%) | 2/35 (5.7%) | 6/137 (4.4%) | ||||
| Visual disturbance | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal discomfort | 3/65 (4.6%) | 0/37 (0%) | 0/35 (0%) | 3/137 (2.2%) | ||||
| Abdominal distension | 16/65 (24.6%) | 9/37 (24.3%) | 9/35 (25.7%) | 34/137 (24.8%) | ||||
| Abdominal hernia | 0/65 (0%) | 2/37 (5.4%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Abdominal mass | 2/65 (3.1%) | 0/37 (0%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Abdominal pain | 22/65 (33.8%) | 7/37 (18.9%) | 12/35 (34.3%) | 41/137 (29.9%) | ||||
| Abdominal pain lower | 2/65 (3.1%) | 2/37 (5.4%) | 4/35 (11.4%) | 8/137 (5.8%) | ||||
| Abdominal pain upper | 5/65 (7.7%) | 2/37 (5.4%) | 1/35 (2.9%) | 8/137 (5.8%) | ||||
| Abdominal tenderness | 3/65 (4.6%) | 0/37 (0%) | 3/35 (8.6%) | 6/137 (4.4%) | ||||
| Anal fissure | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Anal fistula | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Anal inflammation | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Aphthous stomatitis | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Ascites | 5/65 (7.7%) | 1/37 (2.7%) | 3/35 (8.6%) | 9/137 (6.6%) | ||||
| Cheilitis | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Colonic stenosis | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Constipation | 25/65 (38.5%) | 23/37 (62.2%) | 11/35 (31.4%) | 59/137 (43.1%) | ||||
| Diarrhoea | 26/65 (40%) | 12/37 (32.4%) | 17/35 (48.6%) | 55/137 (40.1%) | ||||
| Diverticulum intestinal | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Dry mouth | 3/65 (4.6%) | 3/37 (8.1%) | 3/35 (8.6%) | 9/137 (6.6%) | ||||
| Dyspepsia | 19/65 (29.2%) | 4/37 (10.8%) | 5/35 (14.3%) | 28/137 (20.4%) | ||||
| Dysphagia | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Eructation | 1/65 (1.5%) | 1/37 (2.7%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Flatulence | 6/65 (9.2%) | 1/37 (2.7%) | 1/35 (2.9%) | 8/137 (5.8%) | ||||
| Gastric hypomotility | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Gastritis | 2/65 (3.1%) | 0/37 (0%) | 1/35 (2.9%) | 3/137 (2.2%) | ||||
| Gastrointestinal motility disorder | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Gastrooesophageal reflux disease | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Gingival pain | 5/65 (7.7%) | 6/37 (16.2%) | 1/35 (2.9%) | 12/137 (8.8%) | ||||
| Glossodynia | 1/65 (1.5%) | 0/37 (0%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Haematemesis | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Haemorrhoids | 2/65 (3.1%) | 0/37 (0%) | 1/35 (2.9%) | 3/137 (2.2%) | ||||
| Intestinal obstruction | 0/65 (0%) | 3/37 (8.1%) | 1/35 (2.9%) | 4/137 (2.9%) | ||||
| Lip pain | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Lip ulceration | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Mouth ulceration | 0/65 (0%) | 0/37 (0%) | 2/35 (5.7%) | 2/137 (1.5%) | ||||
| Nausea | 51/65 (78.5%) | 27/37 (73%) | 24/35 (68.6%) | 102/137 (74.5%) | ||||
| Obstruction gastric | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Odynophagia | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Oesophageal spasm | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Oesophagitis | 1/65 (1.5%) | 1/37 (2.7%) | 1/35 (2.9%) | 3/137 (2.2%) | ||||
| Oral discomfort | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Oral pain | 0/65 (0%) | 1/37 (2.7%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Paraesthesia oral | 1/65 (1.5%) | 0/37 (0%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Peritoneal haemorrhage | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Peritonitis | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Proctalgia | 1/65 (1.5%) | 0/37 (0%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Rectal haemorrhage | 1/65 (1.5%) | 0/37 (0%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Retching | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Salivary gland disorder | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Sensitivity of teeth | 0/65 (0%) | 2/37 (5.4%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Small intestinal obstruction | 2/65 (3.1%) | 3/37 (8.1%) | 1/35 (2.9%) | 6/137 (4.4%) | ||||
| Stomach discomfort | 1/65 (1.5%) | 0/37 (0%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Stomatitis | 19/65 (29.2%) | 8/37 (21.6%) | 3/35 (8.6%) | 30/137 (21.9%) | ||||
| Tongue disorder | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Tongue oedema | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Tongue ulceration | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Toothache | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Umbilical hernia | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Vomiting | 26/65 (40%) | 19/37 (51.4%) | 17/35 (48.6%) | 62/137 (45.3%) | ||||
| General disorders | ||||||||
| Asthenia | 2/65 (3.1%) | 1/37 (2.7%) | 2/35 (5.7%) | 5/137 (3.6%) | ||||
| Chest discomfort | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Chest pain | 1/65 (1.5%) | 0/37 (0%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Chills | 8/65 (12.3%) | 1/37 (2.7%) | 4/35 (11.4%) | 13/137 (9.5%) | ||||
| Early satiety | 1/65 (1.5%) | 2/37 (5.4%) | 1/35 (2.9%) | 4/137 (2.9%) | ||||
| Face oedema | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Fatigue | 52/65 (80%) | 30/37 (81.1%) | 27/35 (77.1%) | 109/137 (79.6%) | ||||
| Gait disturbance | 0/65 (0%) | 1/37 (2.7%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Hernia pain | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Influenza like illness | 4/65 (6.2%) | 0/37 (0%) | 0/35 (0%) | 4/137 (2.9%) | ||||
| Infusion site bruising | 2/65 (3.1%) | 0/37 (0%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Infusion site erythema | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Infusion site rash | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Infusion site reaction | 1/65 (1.5%) | 0/37 (0%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Injection site erythema | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Injection site reaction | 0/65 (0%) | 0/37 (0%) | 2/35 (5.7%) | 2/137 (1.5%) | ||||
| Irritability | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Local swelling | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Nodule | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Non-cardiac chest pain | 3/65 (4.6%) | 1/37 (2.7%) | 1/35 (2.9%) | 5/137 (3.6%) | ||||
| Oedema | 3/65 (4.6%) | 2/37 (5.4%) | 1/35 (2.9%) | 6/137 (4.4%) | ||||
| Oedema peripheral | 8/65 (12.3%) | 6/37 (16.2%) | 2/35 (5.7%) | 16/137 (11.7%) | ||||
| Pain | 3/65 (4.6%) | 2/37 (5.4%) | 6/35 (17.1%) | 11/137 (8%) | ||||
| Peripheral coldness | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Pyrexia | 12/65 (18.5%) | 3/37 (8.1%) | 8/35 (22.9%) | 23/137 (16.8%) | ||||
| Temperature intolerance | 0/65 (0%) | 0/37 (0%) | 3/35 (8.6%) | 3/137 (2.2%) | ||||
| Visceral oedema | 1/65 (1.5%) | 1/37 (2.7%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Hepatobiliary disorders | ||||||||
| Cholecystitis | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Jaundice | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Immune system disorders | ||||||||
| Seasonal allergy | 1/65 (1.5%) | 0/37 (0%) | 2/35 (5.7%) | 3/137 (2.2%) | ||||
| Infections and infestations | ||||||||
| Abdominal abscess | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Bacteraemia | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Bacterial infection | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Cellulitis | 2/65 (3.1%) | 0/37 (0%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Clostridial infection | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Cystitis | 3/65 (4.6%) | 0/37 (0%) | 0/35 (0%) | 3/137 (2.2%) | ||||
| Folliculitis | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Fungal infection | 3/65 (4.6%) | 0/37 (0%) | 1/35 (2.9%) | 4/137 (2.9%) | ||||
| Gastroenteritis viral | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Genital herpes | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Gingival infection | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Herpes zoster | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Lung infection | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Nasopharyngitis | 5/65 (7.7%) | 2/37 (5.4%) | 0/35 (0%) | 7/137 (5.1%) | ||||
| Neutropenic infection | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Oral candidiasis | 1/65 (1.5%) | 1/37 (2.7%) | 2/35 (5.7%) | 4/137 (2.9%) | ||||
| Oral herpes | 2/65 (3.1%) | 0/37 (0%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Perianal abscess | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Pharyngitis | 1/65 (1.5%) | 1/37 (2.7%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Pneumonia | 0/65 (0%) | 2/37 (5.4%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Rhinitis | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Sinusitis | 1/65 (1.5%) | 0/37 (0%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Tooth infection | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Upper respiratory tract infection | 2/65 (3.1%) | 3/37 (8.1%) | 0/35 (0%) | 5/137 (3.6%) | ||||
| Urinary tract infection | 4/65 (6.2%) | 5/37 (13.5%) | 10/35 (28.6%) | 19/137 (13.9%) | ||||
| Urosepsis | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Vaginal candidiasis | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Contusion | 2/65 (3.1%) | 1/37 (2.7%) | 0/35 (0%) | 3/137 (2.2%) | ||||
| Excoriation | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Fall | 0/65 (0%) | 2/37 (5.4%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Incision site erythema | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Muscle strain | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Procedural pain | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Sunburn | 2/65 (3.1%) | 0/37 (0%) | 1/35 (2.9%) | 3/137 (2.2%) | ||||
| Tooth fracture | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Investigations | ||||||||
| Blood creatinine increased | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Blood potassium decreased | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Breath sounds abnormal | 1/65 (1.5%) | 2/37 (5.4%) | 1/35 (2.9%) | 4/137 (2.9%) | ||||
| Haemoglobin decreased | 1/65 (1.5%) | 1/37 (2.7%) | 1/35 (2.9%) | 3/137 (2.2%) | ||||
| International normalised ratio increased | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Lymph node palpable | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Oxygen saturation decreased | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Red blood cell count decreased | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Weight decreased | 6/65 (9.2%) | 6/37 (16.2%) | 3/35 (8.6%) | 15/137 (10.9%) | ||||
| White blood cell count decreased | 1/65 (1.5%) | 1/37 (2.7%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| White blood cell count increased | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Anorexia | 27/65 (41.5%) | 15/37 (40.5%) | 12/35 (34.3%) | 54/137 (39.4%) | ||||
| Decreased appetite | 1/65 (1.5%) | 0/37 (0%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Dehydration | 5/65 (7.7%) | 2/37 (5.4%) | 6/35 (17.1%) | 13/137 (9.5%) | ||||
| Fluid overload | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Fluid retention | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Hypercalcaemia | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Hypercholesterolaemia | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Hyperglycaemia | 0/65 (0%) | 1/37 (2.7%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Hypoalbuminaemia | 0/65 (0%) | 1/37 (2.7%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Hypocalcaemia | 0/65 (0%) | 2/37 (5.4%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Hypoglycaemia | 0/65 (0%) | 2/37 (5.4%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Hypokalaemia | 5/65 (7.7%) | 7/37 (18.9%) | 6/35 (17.1%) | 18/137 (13.1%) | ||||
| Hypomagnesaemia | 3/65 (4.6%) | 5/37 (13.5%) | 3/35 (8.6%) | 11/137 (8%) | ||||
| Hyponatraemia | 0/65 (0%) | 1/37 (2.7%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Vitamin B12 deficiency | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 4/65 (6.2%) | 6/37 (16.2%) | 3/35 (8.6%) | 13/137 (9.5%) | ||||
| Arthritis | 0/65 (0%) | 2/37 (5.4%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Back pain | 11/65 (16.9%) | 8/37 (21.6%) | 7/35 (20%) | 26/137 (19%) | ||||
| Bone pain | 2/65 (3.1%) | 2/37 (5.4%) | 0/35 (0%) | 4/137 (2.9%) | ||||
| Costochondritis | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Flank pain | 2/65 (3.1%) | 1/37 (2.7%) | 0/35 (0%) | 3/137 (2.2%) | ||||
| Groin pain | 2/65 (3.1%) | 1/37 (2.7%) | 1/35 (2.9%) | 4/137 (2.9%) | ||||
| Jaw disorder | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Joint swelling | 0/65 (0%) | 2/37 (5.4%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Muscle spasms | 1/65 (1.5%) | 1/37 (2.7%) | 2/35 (5.7%) | 4/137 (2.9%) | ||||
| Muscular weakness | 2/65 (3.1%) | 2/37 (5.4%) | 4/35 (11.4%) | 8/137 (5.8%) | ||||
| Musculoskeletal chest pain | 1/65 (1.5%) | 1/37 (2.7%) | 1/35 (2.9%) | 3/137 (2.2%) | ||||
| Musculoskeletal pain | 4/65 (6.2%) | 1/37 (2.7%) | 0/35 (0%) | 5/137 (3.6%) | ||||
| Myalgia | 3/65 (4.6%) | 1/37 (2.7%) | 2/35 (5.7%) | 6/137 (4.4%) | ||||
| Neck pain | 2/65 (3.1%) | 1/37 (2.7%) | 1/35 (2.9%) | 4/137 (2.9%) | ||||
| Osteoarthritis | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Pain in extremity | 4/65 (6.2%) | 4/37 (10.8%) | 2/35 (5.7%) | 10/137 (7.3%) | ||||
| Pain in jaw | 1/65 (1.5%) | 1/37 (2.7%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Spinal osteoarthritis | 0/65 (0%) | 1/37 (2.7%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Spinal haemangioma | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Nervous system disorders | ||||||||
| Amnesia | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Balance disorder | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Dizziness | 12/65 (18.5%) | 2/37 (5.4%) | 5/35 (14.3%) | 19/137 (13.9%) | ||||
| Dysaesthesia | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Dysgeusia | 17/65 (26.2%) | 4/37 (10.8%) | 6/35 (17.1%) | 27/137 (19.7%) | ||||
| Headache | 15/65 (23.1%) | 5/37 (13.5%) | 4/35 (11.4%) | 24/137 (17.5%) | ||||
| Hypoaesthesia | 0/65 (0%) | 0/37 (0%) | 2/35 (5.7%) | 2/137 (1.5%) | ||||
| Memory impairment | 0/65 (0%) | 1/37 (2.7%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Migraine | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Migraine with aura | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Neuropathy | 2/65 (3.1%) | 1/37 (2.7%) | 0/35 (0%) | 3/137 (2.2%) | ||||
| Neuropathy peripheral | 2/65 (3.1%) | 1/37 (2.7%) | 2/35 (5.7%) | 5/137 (3.6%) | ||||
| Pallanaesthesia | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Paraesthesia | 2/65 (3.1%) | 0/37 (0%) | 2/35 (5.7%) | 4/137 (2.9%) | ||||
| Parosmia | 2/65 (3.1%) | 0/37 (0%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Peripheral sensory neuropathy | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Restless legs syndrome | 0/65 (0%) | 1/37 (2.7%) | 2/35 (5.7%) | 3/137 (2.2%) | ||||
| Somnolence | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Syncope | 1/65 (1.5%) | 0/37 (0%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Tremor | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Trigeminal neuralgia | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Psychiatric disorders | ||||||||
| Agitation | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Anxiety | 2/65 (3.1%) | 1/37 (2.7%) | 3/35 (8.6%) | 6/137 (4.4%) | ||||
| Confusional state | 2/65 (3.1%) | 0/37 (0%) | 2/35 (5.7%) | 4/137 (2.9%) | ||||
| Depression | 8/65 (12.3%) | 1/37 (2.7%) | 3/35 (8.6%) | 12/137 (8.8%) | ||||
| Insomnia | 3/65 (4.6%) | 8/37 (21.6%) | 2/35 (5.7%) | 13/137 (9.5%) | ||||
| Renal and urinary disorders | ||||||||
| Bladder discomfort | 1/65 (1.5%) | 0/37 (0%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Bladder pain | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Bladder spasm | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Dysuria | 2/65 (3.1%) | 2/37 (5.4%) | 2/35 (5.7%) | 6/137 (4.4%) | ||||
| Haematuria | 4/65 (6.2%) | 0/37 (0%) | 1/35 (2.9%) | 5/137 (3.6%) | ||||
| Hydronephrosis | 0/65 (0%) | 0/37 (0%) | 2/35 (5.7%) | 2/137 (1.5%) | ||||
| Incontinence | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Micturition urgency | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Nocturia | 0/65 (0%) | 2/37 (5.4%) | 2/35 (5.7%) | 4/137 (2.9%) | ||||
| Pollakiuria | 2/65 (3.1%) | 3/37 (8.1%) | 3/35 (8.6%) | 8/137 (5.8%) | ||||
| Proteinuria | 3/65 (4.6%) | 0/37 (0%) | 0/35 (0%) | 3/137 (2.2%) | ||||
| Stress urinary incontinence | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Urinary incontinence | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Urinary retention | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Urinary tract obstruction | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Reproductive system and breast disorders | ||||||||
| Breast pain | 2/65 (3.1%) | 0/37 (0%) | 1/35 (2.9%) | 3/137 (2.2%) | ||||
| Genital pain | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Pelvic pain | 0/65 (0%) | 2/37 (5.4%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Vaginal discharge | 2/65 (3.1%) | 0/37 (0%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Vaginal haemorrhage | 4/65 (6.2%) | 0/37 (0%) | 1/35 (2.9%) | 5/137 (3.6%) | ||||
| Vaginal pain | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Vulvovaginal discomfort | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Vulvovaginal pruritus | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Atelectasis | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Cough | 9/65 (13.8%) | 8/37 (21.6%) | 7/35 (20%) | 24/137 (17.5%) | ||||
| Dysphonia | 1/65 (1.5%) | 1/37 (2.7%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Dyspnoea | 20/65 (30.8%) | 6/37 (16.2%) | 7/35 (20%) | 33/137 (24.1%) | ||||
| Dyspnoea exertional | 0/65 (0%) | 2/37 (5.4%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Epistaxis | 1/65 (1.5%) | 1/37 (2.7%) | 2/35 (5.7%) | 4/137 (2.9%) | ||||
| Hiccups | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Hypoxia | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Increased upper airway secretion | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Nasal congestion | 2/65 (3.1%) | 2/37 (5.4%) | 1/35 (2.9%) | 5/137 (3.6%) | ||||
| Nasal dryness | 2/65 (3.1%) | 0/37 (0%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Pharyngolaryngeal pain | 6/65 (9.2%) | 7/37 (18.9%) | 9/35 (25.7%) | 22/137 (16.1%) | ||||
| Pleural effusion | 2/65 (3.1%) | 2/37 (5.4%) | 1/35 (2.9%) | 5/137 (3.6%) | ||||
| Pleuritic pain | 1/65 (1.5%) | 1/37 (2.7%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Postnasal drip | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Productive cough | 2/65 (3.1%) | 0/37 (0%) | 1/35 (2.9%) | 3/137 (2.2%) | ||||
| Pulmonary congestion | 0/65 (0%) | 2/37 (5.4%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Pulmonary embolism | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Respiration abnormal | 0/65 (0%) | 1/37 (2.7%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Respiratory failure | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Rhonchi | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Sinus congestion | 3/65 (4.6%) | 1/37 (2.7%) | 0/35 (0%) | 4/137 (2.9%) | ||||
| Sneezing | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Wheezing | 3/65 (4.6%) | 0/37 (0%) | 0/35 (0%) | 3/137 (2.2%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Acne | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Alopecia | 40/65 (61.5%) | 24/37 (64.9%) | 26/35 (74.3%) | 90/137 (65.7%) | ||||
| Dry skin | 2/65 (3.1%) | 2/37 (5.4%) | 0/35 (0%) | 4/137 (2.9%) | ||||
| Ecchymosis | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Erythema | 3/65 (4.6%) | 1/37 (2.7%) | 0/35 (0%) | 4/137 (2.9%) | ||||
| Hair colour changes | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Hyperhidrosis | 2/65 (3.1%) | 2/37 (5.4%) | 2/35 (5.7%) | 6/137 (4.4%) | ||||
| Nail discolouration | 0/65 (0%) | 2/37 (5.4%) | 2/35 (5.7%) | 4/137 (2.9%) | ||||
| Nail disorder | 3/65 (4.6%) | 0/37 (0%) | 3/35 (8.6%) | 6/137 (4.4%) | ||||
| Night sweats | 1/65 (1.5%) | 1/37 (2.7%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Pain of skin | 0/65 (0%) | 2/37 (5.4%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Petechiae | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Pruritus | 2/65 (3.1%) | 3/37 (8.1%) | 2/35 (5.7%) | 7/137 (5.1%) | ||||
| Rash | 3/65 (4.6%) | 4/37 (10.8%) | 2/35 (5.7%) | 9/137 (6.6%) | ||||
| Rash macular | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Skin discolouration | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Skin hyperpigmentation | 0/65 (0%) | 1/37 (2.7%) | 1/35 (2.9%) | 2/137 (1.5%) | ||||
| Skin nodule | 2/65 (3.1%) | 0/37 (0%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Skin odour abnormal | 2/65 (3.1%) | 0/37 (0%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Subcutaneous nodule | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Urticaria | 1/65 (1.5%) | 1/37 (2.7%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Vascular disorders | ||||||||
| Arteriosclerosis | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Deep vein thrombosis | 2/65 (3.1%) | 0/37 (0%) | 0/35 (0%) | 2/137 (1.5%) | ||||
| Flushing | 2/65 (3.1%) | 2/37 (5.4%) | 3/35 (8.6%) | 7/137 (5.1%) | ||||
| Hot flush | 6/65 (9.2%) | 1/37 (2.7%) | 5/35 (14.3%) | 12/137 (8.8%) | ||||
| Hypertension | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Hypotension | 1/65 (1.5%) | 1/37 (2.7%) | 2/35 (5.7%) | 4/137 (2.9%) | ||||
| Lymphoedema | 0/65 (0%) | 1/37 (2.7%) | 0/35 (0%) | 1/137 (0.7%) | ||||
| Orthostatic hypotension | 0/65 (0%) | 0/37 (0%) | 1/35 (2.9%) | 1/137 (0.7%) | ||||
| Phlebitis | 1/65 (1.5%) | 0/37 (0%) | 0/35 (0%) | 1/137 (0.7%) | ||||
Limitations/Caveats
No statistical testings were performed to compare any of the treatment groups. No p-values or odds ratios were reported.
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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Dr. Linda Neuman, Vice President, Clinical Development |
|---|---|
| Organization | Sunesis Pharmaceuticals, Inc. |
| Phone | (650) 266-3760 |
| lneuman@sunesis.com |
Responsible Party:
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00408603
Other Study ID Numbers:
- SPO-0010
First Posted:
Dec 7, 2006
Last Update Posted:
Jul 27, 2017
Last Verified:
Jun 1, 2017