A Study of SB-743921 in Non-Hodgkin Lymphoma and Hodgkin Lymphoma

Sponsor
Cytokinetics (Industry)
Overall Status
Completed
CT.gov ID
NCT00343564
Collaborator
(none)
68
Enrollment
8
Locations
2
Arms
51
Duration (Months)
8.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was an early-phase trial arranged into two phases. The Phase I portion was a dose-escalation study designed to assess the safety, tolerability and to identify the maximum tolerated dose of SB-743921 in patients with Non-Hodgkin Lymphoma and Hodgkin Lymphoma. Phase II was intended to assess the activity, safety and tolerability of SB-743921 in patients with Indolent and Aggressive Non-Hodgkin's Lymphomas exclusively. The Phase II portion of the study was not initiated.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I-II Study to Determine the Safety, Pharmacokinetics and Potential Efficacy of Intravenous Administration of SB-743921 on Days 1 and 15 of a 28-Day Dosing Schedule in Patients With Non-Hodgkin Lymphoma and Hodgkin Lymphoma
Study Start Date :
Apr 1, 2006
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

ArmIntervention/Treatment
Experimental: Phase 1 Dose Escalation

Phase 1 dose escalation without and with GCSF support

Drug: SB-743921
Phase 1: I.V. dose on Days 1 and 15 of a 28 day cycle starting at 2mg/m2 and increasing by 1 mg/m2 with possible prophylactic granulopoietic support until unacceptable toxicity develops.

Experimental: Phase 2 Fixed Dose

Phase 2 fixed dose based on Phase I findings stratified by NHL type

Drug: SB-743921
Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.

Outcome Measures

Primary Outcome Measures

  1. Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF. [28 days]

    Maximum Tolerated Dose (MTD) was determined by testing increasing doses in cohorts with at least 3 patients each. MTD reflects the highest dose of drug that did not cause dose limiting toxicity (DLT).

Secondary Outcome Measures

  1. Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1 [Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose]

  2. Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day1 [Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose]

  3. Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1 [Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose]

  4. Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1 [Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose]

  5. Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 [Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose]

  6. Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 [Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose]

  7. Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 [Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose]

  8. Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 [Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose]

Eligibility Criteria

Criteria

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

Inclusion Criteria: Phase 1: Patients with evaluable or measurable (by MRI or CT) Hodgkin's Disease or Non-Hodgkin's Lymphoma. Phase 2: Patients with Measurable Non-Hodgkin's Lymphomas (Indolent or Aggressive) only. - Patients with Indolent NHL must be relapsed or refractory to at least one prior line of therapy (CHOP, CVP, chlorambucil or fludaribine). Prior treatment with Rituximab is required. - Patients with Aggressive NHL refractory to (or relapsed from) at least one CHOP-based therapy who have had prior treatment with Rituximab and who are not candidates for high-dose chemotherapy or autologous stem cell transplantation. - ECOG performance status 0-2 - Autologous stem cell transplant recipients are eligible if 100 days have elapsed since procedure. Exclusion Criteria: Phase 1: History of prior radioimmunotherapy (Bexxar, Zevalin); These patients ARE permitted in the Phase 2 trial. - Current active malignancy besides NHL, except excised non-melanoma skin cancer, in-situ cervical or bladder cancer or early stage prostate cancer. - Patients with leptomeningeal of CNS lymphoma - Known allergy to and/or receipt of treatments contraindicated by administration of G-CSF - Patients with active Hepatitis B or C, or patients with HIV infection. - Pregnant or breast-feeding females. - Previous treatment with a KSP inhibitor

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Hackensack University Medical CenterHackensackNew JerseyUnited States07601
2Cornell University Medical CenterNew YorkNew YorkUnited States10021
3Memorial Sloan-Kettering Caner CenterNew YorkNew YorkUnited States10021
4Herbert Irving Comprehensive Cancer CenterNew YorkNew YorkUnited States10032
5University of North CarolinaChapel HillNorth CarolinaUnited States27599
6Sarah Cannon Cancer Research InstituteNashvilleTennesseeUnited States37203
7Russian Medical Academy of Postgraduate EducationMoscowRussian Federation115478
8St. Petersburg State PAVLOV Medical UniversitySaint PetersburgRussian Federation197002

Sponsors and Collaborators

  • Cytokinetics

Investigators

  • Principal Investigator: Owen O'Connor, M.D./Ph.D., Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cytokinetics
ClinicalTrials.gov Identifier:
NCT00343564
Other Study ID Numbers:
  • CY 2121
First Posted:
Jun 23, 2006
Last Update Posted:
Jan 13, 2020
Last Verified:
Jan 1, 2020
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title2 mg/m2 Without GCSF3 mg/m2 Without GCSF4 mg/m2 Without GCSF5 mg/m2 Without GCSF6 mg/m2 Without GCSF7 mg/m2 Without GCSF6 mg/m2 With GCSF7 mg/m2 With GCSF8 mg/m2 With GCSF9 mg/m2 With GCSF10 mg/m2 With GCSF
Arm/Group DescriptionPhase 1 dose escalation cohort 1 without GCSF supportPhase 1 dose escalation cohort 2 without GCSF supportPhase 1 dose escalation cohort 3 without GCSF supportPhase 1 dose escalation cohort 4 without GCSF supportPhase 1 dose escalation cohort 5 without GCSF supportPhase 1 dose escalation cohort 6 without GCSF supportPhase 1 dose escalation cohort 1 with GCSF supportPhase 1 dose escalation cohort 2 with GCSF supportPhase 1 dose escalation cohort 3 with GCSF supportPhase 1 dose escalation cohort 4 with GCSF supportPhase 1 dose escalation cohort 5 with GCSF support
Period Title: Overall Study
STARTED673710943388
COMPLETED673710943388
NOT COMPLETED00000000000

Baseline Characteristics

Arm/Group Title2 mg/m2 Without GCSF3 mg/m2 Without GCSF4 mg/m2 Without GCSF5 mg/m2 Without GCSF6 mg/m2 Without GCSF7 mg/m2 Without GCSF6 mg/m2 With GCSF7 mg/m2 With GCSF8 mg/m2 With GCSF9 mg/m2 With GCSF10 mg/m2 With GCSFTotal
Arm/Group DescriptionPhase 1 dose escalation cohort 1 without GCSF supportPhase 1 dose escalation cohort 2 without GCSF supportPhase 1 dose escalation cohort 3 without GCSF supportPhase 1 dose escalation cohort 4 without GCSF supportPhase 1 dose escalation cohort 5 without GCSF supportPhase 1 dose escalation cohort 6 without GCSF supportPhase 1 dose escalation cohort 1 with GCSF supportPhase 1 dose escalation cohort 2 with GCSF supportPhase 1 dose escalation cohort 3 with GCSF supportPhase 1 dose escalation cohort 4 with GCSF supportPhase 1 dose escalation cohort 5 with GCSF supportTotal of all reporting groups
Overall Participants67371094338868
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
0
0%
0
0%
1
11.1%
0
0%
0
0%
0
0%
0
0%
0
0%
1
1.5%
Between 18 and 65 years
4
66.7%
7
100%
3
100%
3
42.9%
8
80%
6
66.7%
1
25%
2
66.7%
1
33.3%
4
50%
4
50%
43
63.2%
>=65 years
2
33.3%
0
0%
0
0%
4
57.1%
2
20%
2
22.2%
3
75%
1
33.3%
2
66.7%
4
50%
4
50%
24
35.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
62
(9)
43
(13)
33
(9)
57
(22)
48
(16)
42
(24)
69
(12)
63
(11)
63
(17)
48
(22)
56
(20)
52
(19)
Sex: Female, Male (Count of Participants)
Female
4
66.7%
6
85.7%
1
33.3%
2
28.6%
4
40%
4
44.4%
2
50%
1
33.3%
1
33.3%
3
37.5%
1
12.5%
29
42.6%
Male
2
33.3%
1
14.3%
2
66.7%
5
71.4%
6
60%
5
55.6%
2
50%
2
66.7%
2
66.7%
5
62.5%
7
87.5%
39
57.4%
Region of Enrollment (participants) [Number]
United States
6
100%
4
57.1%
1
33.3%
5
71.4%
7
70%
6
66.7%
4
100%
3
100%
2
66.7%
8
100%
7
87.5%
53
77.9%
Russian Federation
0
0%
3
42.9%
2
66.7%
2
28.6%
3
30%
3
33.3%
0
0%
0
0%
1
33.3%
0
0%
1
12.5%
15
22.1%

Outcome Measures

1. Primary Outcome
TitlePhase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF.
DescriptionMaximum Tolerated Dose (MTD) was determined by testing increasing doses in cohorts with at least 3 patients each. MTD reflects the highest dose of drug that did not cause dose limiting toxicity (DLT).
Time Frame28 days

Outcome Measure Data

Analysis Population Description
Safety population; all patients who received at least 1 dose of study drug were included in the intent-to-treat/safety populations. Efficacy evaluable; any patient who received both cycles of treatment.
Arm/Group TitleDose Escalation Cohort 1 2 mg/m2 (w/o GCSF)Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)Dose Escalation Cohort 5 6 mg/m2 (w/o GCSF)Dose Escalation Cohort 6 7 mg/m2 (w/o GCSF)Dose Escalation Cohort 1 6 mg/m2 (w/ GCSF)Dose Escalation Cohort 2 7mg/m2 (w/GCSF)Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)
Arm/Group DescriptionMaximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF supportMaximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF supportMaximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF supportMaximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF supportMaximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF supportMaximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF supportMaximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF supportMaximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF supportMaximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF supportMaximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF supportMaximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support
Measure Participants46356943376
Number [mg/m2]
2
3
4
5
6
6
6
7
8
9
9
2. Secondary Outcome
TitleCharacterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1
Description
Time FramePre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleDose Escalation Cohort 1 2 mg/m2 (w/o GCSF)Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)
Arm/Group DescriptionDay 1 CmaxDay 1 CmaxDay 1 CmaxDay 1 CmaxDay 1 CmaxDay 1 CmaxDay 1 CmaxDay 1 CmaxDay 1 Cmax
Measure Participants56361312376
Mean (Standard Deviation) [ng/mL]
172
(40.7)
348
(86.6)
357
(50.4)
514
(177)
600
(175)
689
(401)
1130
(189)
805
(501)
1180
(682)
3. Secondary Outcome
TitleCharacterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day1
Description
Time FramePre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleDose Escalation Cohort 1 2 mg/m2 (w/o GCSF)Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)
Arm/Group DescriptionDay 1 TmaxDay 1 TmaxDay 1 TmaxDay 1 TmaxDay 1 TmaxDay 1 TmaxDay 1 TmaxDay 1 TmaxDay 1 Tmax
Measure Participants56361312376
Mean (Standard Deviation) [hr]
1.20
(0.45)
1.00
(0.00)
1.00
(0.00)
1.00
(0.00)
1.08
(0.28)
1.00
(0.43)
1.00
(0.00)
1.00
(0.00)
1.17
(0.41)
4. Secondary Outcome
TitleCharacterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1
Description
Time FramePre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleDose Escalation Cohort 1 2 mg/m2 (w/o GCSF)Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)
Arm/Group DescriptionDay 1 ClastDay 1 ClastDay 1 ClastDay 1 ClastDay 1 ClastDay 1 ClastDay 1 ClastDay 1 ClastDay 1 Clast
Measure Participants56361312376
Mean (Standard Deviation) [ng/mL]
36.9
(23.6)
61.6
(29.4)
59.5
(39.9)
79.1
(51.9)
133
(64.7)
103
(48.3)
144
(97.6)
122
(69.6)
245
(134)
5. Secondary Outcome
TitleCharacterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1
Description
Time FramePre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleDose Escalation Cohort 1 2 mg/m2 (w/o GCSF)Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)
Arm/Group DescriptionDay 1 AUClastDay 1 AUClastDay 1 AUClastDay 1 AUClastDay 1 AUClastDay 1 AUClastDay 1 AUClastDay 1 AUClastDay 1 AUClast
Measure Participants56361312376
Mean (Standard Deviation) [hr*ng/mL]
1807
(1104)
2800
(988.6)
3269
(950.2)
3707
(1750)
5838
(2588)
5359
(3028)
6270
(2751)
5875
(3483)
11570
(6318)
6. Secondary Outcome
TitleCharacterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15
Description
Time FramePre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleDose Escalation Cohort 1 2 mg/m2 (w/o GCSF)Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)
Arm/Group DescriptionDay 15 CmaxDay 15 CmaxDay 15 CmaxDay 15 CmaxDay 15 CmaxDay 15 CmaxDay 15 CmaxDay 15 CmaxDay 15 Cmax
Measure Participants3538138376
Mean (Standard Deviation) [ng/mL]
220
(51.2)
323
(120)
365
(45.2)
599
(383)
717
(278)
835
(442)
685
(163)
706
(344)
1430
(1620)
7. Secondary Outcome
TitleCharacterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15
Description
Time FramePre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleDose Escalation Cohort 1 2 mg/m2 (w/o GCSF)Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)
Arm/Group DescriptionDay 15 TmaxDay 15 TmaxDay 15 TmaxDay 15 TmaxDay 15 TmaxDay 15 TmaxDay 15 TmaxDay 15 TmaxDay 15 Tmax
Measure Participants3538138376
Mean (Standard Deviation) [hr]
1.00
(0.00)
1.00
(0.00)
1.00
(0.00)
1.00
(0.00)
1.00
(0.00)
1.00
(0.00)
1.00
(0.00)
1.00
(0.00)
1.00
(0.00)
8. Secondary Outcome
TitleCharacterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15
Description
Time FramePre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleDose Escalation Cohort 1 2 mg/m2 (w/o GCSF)Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)
Arm/Group DescriptionDay 15 ClastDay 15 ClastDay 15 ClastDay 15 ClastDay 15 ClastDay 15 ClastDay 15 ClastDay 15 ClastDay 15 Clast
Measure Participants3538138376
Mean (Standard Deviation) [ng/mL]
29.2
(11.8)
84.2
(60.8)
58.5
(29.8)
84.6
(47.9)
138
(103)
92.4
(50.5)
138
(94.9)
150
(105)
285
(290)
9. Secondary Outcome
TitleCharacterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15
Description
Time FramePre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleDose Escalation Cohort 1 2 mg/m2 (w/o GCSF)Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF)Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF)Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF)Dose Escalation Cohort 5 6 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 6 7 mg/m2 (w/ and w/o GCSF)Dose Escalation Cohort 3 8 mg/m2 (w/GCSF)Dose Escalation Cohort 4 9 mg/m2 (w/GCSF)Dose Escalation Cohort 5 10 mg/m2 (w/GCSF)
Arm/Group DescriptionDay 15 AUClastDay 15 AUClastDay 15 AUClastDay 15 AUClastDay 15 AUClastDay 15 AUClastDay 15 AUClastDay 15 AUClastDay 15 Clast
Measure Participants3538138376
Mean (Standard Deviation) [hr*ng/mL]
1809
(464.1)
2363
(1187)
3380
(1456)
4105
(2190)
5869
(3417)
5116
(1728)
6041
(3010)
6178
(3630)
12590
(17850)

Adverse Events

Time FrameAdverse events were collected during the 28-day treatment period and at a 14-day follow up visit.
Adverse Event Reporting Description Patients who received at least 1 dose of treatment were considered eligible for safety.
Arm/Group Title2 mg/m2 Without GCSF3 mg/m2 Without GCSF4 mg/m2 Without GCSF5 mg/m2 Without GCSF6 mg/m2 Without GCSF7 mg/m2 Without GCSF6 mg/m2 With GCSF7 mg/m2 With GCSF8 mg/m2 With GCSF9 mg/m2 With GCSF10 mg/m2 With GCSF
Arm/Group DescriptionPhase 1 dose escalation cohort 1 without GCSF supportPhase 1 dose escalation cohort 2 without GCSF supportPhase 1 dose escalation cohort 3 without GCSF supportPhase 1 dose escalation cohort 4 without GCSF supportPhase 1 dose escalation cohort 5 without GCSF supportPhase 1 dose escalation cohort 6 without GCSF supportPhase 1 dose escalation cohort 1 with GCSF supportPhase 1 dose escalation cohort 2 with GCSF supportPhase 1 dose escalation cohort 3 with GCSF supportPhase 1 dose escalation cohort 4 with GCSF supportPhase 1 dose escalation cohort 5 with GCSF support
All Cause Mortality
2 mg/m2 Without GCSF3 mg/m2 Without GCSF4 mg/m2 Without GCSF5 mg/m2 Without GCSF6 mg/m2 Without GCSF7 mg/m2 Without GCSF6 mg/m2 With GCSF7 mg/m2 With GCSF8 mg/m2 With GCSF9 mg/m2 With GCSF10 mg/m2 With GCSF
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
2 mg/m2 Without GCSF3 mg/m2 Without GCSF4 mg/m2 Without GCSF5 mg/m2 Without GCSF6 mg/m2 Without GCSF7 mg/m2 Without GCSF6 mg/m2 With GCSF7 mg/m2 With GCSF8 mg/m2 With GCSF9 mg/m2 With GCSF10 mg/m2 With GCSF
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total2/5 (40%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 3/10 (30%) 1/9 (11.1%) 1/4 (25%) 1/3 (33.3%) 0/3 (0%) 1/7 (14.3%) 3/7 (42.9%)
Blood and lymphatic system disorders
Neutropenia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Anaemia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Haemolytic anaemia1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Cardiac disorders
Atrial fibrillation0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
General disorders
Heparin-induced thrombocytopenia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Sudden death0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Hepatobiliary disorders
Hyperbilirubinaemia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Infections and infestations
Sepsis0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Clostridium infection0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Enterobacter bacteraemia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Pneumococcal bacteraemia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 1/3 (33.3%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Pneumonia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Staphyloccal infection0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Injury, poisoning and procedural complications
Procedural hypotension1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Metabolism and nutrition disorders
Dehydration0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant plural effusion1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Renal and urinary disorders
Haematuria0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Renal failure acute0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Other (Not Including Serious) Adverse Events
2 mg/m2 Without GCSF3 mg/m2 Without GCSF4 mg/m2 Without GCSF5 mg/m2 Without GCSF6 mg/m2 Without GCSF7 mg/m2 Without GCSF6 mg/m2 With GCSF7 mg/m2 With GCSF8 mg/m2 With GCSF9 mg/m2 With GCSF10 mg/m2 With GCSF
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total5/5 (100%) 6/6 (100%) 3/3 (100%) 6/6 (100%) 10/10 (100%) 8/9 (88.9%) 4/4 (100%) 3/3 (100%) 3/3 (100%) 7/7 (100%) 7/7 (100%)
Blood and lymphatic system disorders
Anaemia1/5 (20%) 1/6 (16.7%) 0/3 (0%) 1/6 (16.7%) 4/10 (40%) 2/9 (22.2%) 2/4 (50%) 1/3 (33.3%) 0/3 (0%) 1/7 (14.3%) 5/7 (71.4%)
Eosinophilia0/5 (0%) 01/6 (16.7%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Febrile neutropenia0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 01/7 (14.3%) 0
Leukocytosis0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 02/7 (28.6%) 00/7 (0%) 0
Leukopenia0/5 (0%) 00/6 (0%) 01/3 (33.3%) 01/6 (16.7%) 02/10 (20%) 00/9 (0%) 02/4 (50%) 00/3 (0%) 01/3 (33.3%) 02/7 (28.6%) 01/7 (14.3%) 0
Lymph node pain0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 01/10 (10%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Lymphocytosis0/5 (0%) 01/6 (16.7%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Lymphopenia0/5 (0%) 00/6 (0%) 01/3 (33.3%) 00/6 (0%) 01/10 (10%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 02/7 (28.6%) 01/7 (14.3%) 0
Neutropenia0/5 (0%) 01/6 (16.7%) 01/3 (33.3%) 05/6 (83.3%) 05/10 (50%) 07/9 (77.8%) 03/4 (75%) 01/3 (33.3%) 03/3 (100%) 04/7 (57.1%) 05/7 (71.4%) 0
Pancytopenia0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 01/7 (14.3%) 0
Thrombocytopenia1/5 (20%) 0/6 (0%) 0/3 (0%) 2/6 (33.3%) 1/10 (10%) 2/9 (22.2%) 2/4 (50%) 1/3 (33.3%) 2/3 (66.7%) 3/7 (42.9%) 5/7 (71.4%)
Cardiac disorders
Atrial fibrillation0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 01/10 (10%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Supraventricular extrasystoles0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 01/4 (25%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Tachycardia0/5 (0%) 01/6 (16.7%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Ear and labyrinth disorders
Hypoacusis0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 01/3 (33.3%) 00/7 (0%) 00/7 (0%) 0
Eye disorders
Conjunctival haemorrhage0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 01/4 (25%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Vision blurred0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 01/10 (10%) 00/9 (0%) 01/4 (25%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Visual disturbance0/5 (0%) 00/6 (0%) 00/3 (0%) 01/6 (16.7%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Gastrointestinal disorders
Abdominal discomfort1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Abdominal distension0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 02/9 (22.2%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Abdominal pain0/5 (0%) 02/6 (33.3%) 01/3 (33.3%) 00/6 (0%) 00/10 (0%) 01/9 (11.1%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 01/7 (14.3%) 02/7 (28.6%) 0
Abdominal pain upper0/5 (0%) 01/6 (16.7%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 01/9 (11.1%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Constipation0/5 (0%) 00/6 (0%) 01/3 (33.3%) 01/6 (16.7%) 01/10 (10%) 01/9 (11.1%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 01/7 (14.3%) 04/7 (57.1%) 0
Diarrhoea2/5 (40%) 2/6 (33.3%) 0/3 (0%) 1/6 (16.7%) 0/10 (0%) 1/9 (11.1%) 1/4 (25%) 0/3 (0%) 1/3 (33.3%) 1/7 (14.3%) 0/7 (0%)
Dry mouth0/5 (0%) 00/6 (0%) 01/3 (33.3%) 00/6 (0%) 01/10 (10%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 01/7 (14.3%) 0
Dyspepsia0/5 (0%) 01/6 (16.7%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 01/4 (25%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Dysphagia1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Gastritis0/5 (0%) 01/6 (16.7%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Gastrooesophageal reflux disease0/5 (0%) 00/6 (0%) 00/3 (0%) 01/6 (16.7%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Intestinal obstruction0/5 (0%) 00/6 (0%) 00/3 (0%) 01/6 (16.7%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Lip ulceration0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 01/9 (11.1%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Nausea1/5 (20%) 2/6 (33.3%) 0/3 (0%) 0/6 (0%) 3/10 (30%) 1/9 (11.1%) 1/4 (25%) 1/3 (33.3%) 0/3 (0%) 2/7 (28.6%) 2/7 (28.6%)
Stomach discomfort0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 01/4 (25%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Stomatitis0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 01/9 (11.1%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 01/7 (14.3%) 01/7 (14.3%) 0
Vomiting1/5 (20%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 1/9 (11.1%) 0/4 (0%) 1/3 (33.3%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
General disorders
Asthenia0/5 (0%) 01/6 (16.7%) 00/3 (0%) 00/6 (0%) 02/10 (20%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 02/7 (28.6%) 00/7 (0%) 0
Chest discomfort0/5 (0%) 00/6 (0%) 00/3 (0%) 01/6 (16.7%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Chest pain0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 01/7 (14.3%) 00/7 (0%) 0
Chills1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Fatigue3/5 (60%) 2/6 (33.3%) 2/3 (66.7%) 1/6 (16.7%) 1/10 (10%) 4/9 (44.4%) 1/4 (25%) 3/3 (100%) 1/3 (33.3%) 3/7 (42.9%) 5/7 (71.4%)
Gait disturbance0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 01/7 (14.3%) 0
Malaise0/5 (0%) 00/6 (0%) 01/3 (33.3%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Oedema1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 1/3 (33.3%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Oedema peripheral0/5 (0%) 00/6 (0%) 01/3 (33.3%) 01/6 (16.7%) 01/10 (10%) 01/9 (11.1%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 02/7 (28.6%) 0
Pain0/5 (0%) 00/6 (0%) 00/3 (0%) 00/6 (0%) 01/10 (10%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Performance status decreased0/5 (0%) 01/6 (16.7%) 00/3 (0%) 00/6 (0%) 02/10 (20%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Peripheral coldness0/5 (0%) 01/6 (16.7%) 00/3 (0%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Pyrexia1/5 (20%) 2/6 (33.3%) 1/3 (33.3%) 0/6 (0%) 2/10 (20%) 3/9 (33.3%) 1/4 (25%) 0/3 (0%) 1/3 (33.3%) 5/7 (71.4%) 0/7 (0%)
Suprapubic pain0/5 (0%) 00/6 (0%) 00/3 (0%) 01/6 (16.7%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Thirst0/5 (0%) 00/6 (0%) 01/3 (33.3%) 00/6 (0%) 00/10 (0%) 00/9 (0%) 00/4 (0%) 00/3 (0%) 00/3 (0%) 00/7 (0%) 00/7 (0%) 0
Hepatobiliary disorders
Hyperbilirubinaemia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Immune system disorders
Drug hypersensitivity1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Infections and infestations
Bronchitis0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Herpes simplex0/5 (0%) 1/6 (16.7%) 0/3 (0%) 1/6 (16.7%) 0/10 (0%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Herpes virus infection0/5 (0%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Herpes zoster0/5 (0%) 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Respiratory tract infection0/5 (0%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Respiratory tract infection viral0/5 (0%) 0/6 (0%) 1/3 (33.3%) 1/6 (16.7%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Rhinitis0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Sinusitis0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 1/3 (33.3%) 0/7 (0%) 0/7 (0%)
Skin infection0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Tooth infection0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Upper respiratory tract infection0/5 (0%) 2/6 (33.3%) 0/3 (0%) 1/6 (16.7%) 0/10 (0%) 1/9 (11.1%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 2/7 (28.6%) 1/7 (14.3%)
Urinary tract infection0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 1/3 (33.3%) 1/3 (33.3%) 0/7 (0%) 0/7 (0%)
Vulvovaginal mycotic infection0/5 (0%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Injury, poisoning and procedural complications
Incision site complication0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Sunburn0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Tooth fracture0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Tracheal obstruction0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Investigations
Alanine aminotransferase increased0/5 (0%) 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 1/10 (10%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Aspartate aminotransferase increased0/5 (0%) 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 1/10 (10%) 2/9 (22.2%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 2/7 (28.6%) 0/7 (0%)
Blood alkaline phosphatase increased0/5 (0%) 1/6 (16.7%) 1/3 (33.3%) 0/6 (0%) 1/10 (10%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 1/7 (14.3%)
Blood bicarbonate decreased0/5 (0%) 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Blood creatinine increased1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
C-reactive protein increased0/5 (0%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Electrocardiogram QT corrected interval prolonged0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Gamma-glutamyltransferase increased0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Urine colour abnormal0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Urine output decreased1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Weight decreased1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 1/3 (33.3%) 1/7 (14.3%) 0/7 (0%)
Metabolism and nutrition disorders
Acidosis0/5 (0%) 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Anorexia0/5 (0%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 2/9 (22.2%) 0/4 (0%) 1/3 (33.3%) 0/3 (0%) 2/7 (28.6%) 3/7 (42.9%)
Cachexia0/5 (0%) 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Dehydration0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Hypercalcaemia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Hyperglycaemia1/5 (20%) 1/6 (16.7%) 0/3 (0%) 1/6 (16.7%) 4/10 (40%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Hyperkalaemia0/5 (0%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Hypermagnesaemia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Hypertriglyceridaemia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Hyperuricaemia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 1/4 (25%) 0/3 (0%) 2/3 (66.7%) 2/7 (28.6%) 0/7 (0%)
Hypoalbuminaemia0/5 (0%) 0/6 (0%) 1/3 (33.3%) 1/6 (16.7%) 2/10 (20%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 2/7 (28.6%) 0/7 (0%)
Hypocalcaemia0/5 (0%) 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Hypoglycaemia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Hypokalaemia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Hypomagnesaemia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Hyponatraemia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 3/10 (30%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 2/7 (28.6%) 1/7 (14.3%)
Hypophosphataemia0/5 (0%) 0/6 (0%) 1/3 (33.3%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 1/3 (33.3%) 1/7 (14.3%) 0/7 (0%)
Metabolic acidosis0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Polydipsia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Musculoskeletal and connective tissue disorders
Arthralgia1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Back pain0/5 (0%) 2/6 (33.3%) 0/3 (0%) 0/6 (0%) 2/10 (20%) 0/9 (0%) 0/4 (0%) 2/3 (66.7%) 0/3 (0%) 0/7 (0%) 2/7 (28.6%)
Bone pain1/5 (20%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 2/7 (28.6%) 0/7 (0%)
Flank pain0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Limb discomfort0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Muscle spasms0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Musculoskeletal chest pain0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Myalgia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Neck pain0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Pain in extremity0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Sacral pain0/5 (0%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Shoulder pain0/5 (0%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 1/3 (33.3%) 0/7 (0%) 0/7 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Nervous system disorders
Dizziness1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 2/7 (28.6%)
Dysarthria0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Dysgeusia2/5 (40%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Headache0/5 (0%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 2/9 (22.2%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Hypoaesthesia0/5 (0%) 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Neuropathy0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Neuropathy peripheral1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Paraesthesia2/5 (40%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Parosmia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Peripheral sensory neuropathy0/5 (0%) 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/10 (0%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Sinus headache0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Somnolence0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Psychiatric disorders
Anxiety0/5 (0%) 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Depression0/5 (0%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 1/3 (33.3%) 0/7 (0%) 0/7 (0%)
Insomnia0/5 (0%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Libido decreased0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Mental status changes0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Renal and urinary disorders
Dysuria0/5 (0%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 1/3 (33.3%) 0/7 (0%) 0/7 (0%)
Neurogenic bladder0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Pollakiuria1/5 (20%) 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Polyuria0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 1/3 (33.3%) 0/7 (0%) 0/7 (0%)
Urinary tract obstruction0/5 (0%) 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Reproductive system and breast disorders
Erectile dysfunction0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Vaginal discharge0/5 (0%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Respiratory, thoracic and mediastinal disorders
Atelectasis0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Cough1/5 (20%) 2/6 (33.3%) 0/3 (0%) 0/6 (0%) 2/10 (20%) 1/9 (11.1%) 1/4 (25%) 0/3 (0%) 1/3 (33.3%) 3/7 (42.9%) 0/7 (0%)
Dysphonia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Dyspnoea1/5 (20%) 1/6 (16.7%) 0/3 (0%) 1/6 (16.7%) 1/10 (10%) 2/9 (22.2%) 1/4 (25%) 2/3 (66.7%) 1/3 (33.3%) 3/7 (42.9%) 0/7 (0%)
Dyspnoea exertional0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 1/3 (33.3%) 1/7 (14.3%) 2/7 (28.6%)
Epistaxis0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 1/7 (14.3%)
Hiccups0/5 (0%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Hypoxia0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 1/3 (33.3%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Nasal congestion0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Pharyngolaryngeal pain0/5 (0%) 1/6 (16.7%) 1/3 (33.3%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Pleural effusion0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Productive cough0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 1/7 (14.3%)
Respiratory failure0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Rhinitis allergic0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Rhinorrhoea0/5 (0%) 1/6 (16.7%) 1/3 (33.3%) 0/6 (0%) 0/10 (0%) 1/9 (11.1%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Wheezing0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 2/9 (22.2%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Skin and subcutaneous tissue disorders
Alopecia1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Dry skin1/5 (20%) 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/10 (0%) 1/9 (11.1%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Hyperhidrosis0/5 (0%) 1/6 (16.7%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 2/9 (22.2%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Night sweats0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 1/7 (14.3%) 0/7 (0%)
Palmar erythema0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Pruritus0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 2/9 (22.2%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Rash0/5 (0%) 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/10 (0%) 1/9 (11.1%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Rash maculo-papular0/5 (0%) 0/6 (0%) 0/3 (0%) 1/6 (16.7%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Skin ulcer0/5 (0%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 1/7 (14.3%)
Urticaria1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 1/4 (25%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Vascular disorders
Phlebitis1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Thrombosis1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)
Vein discolouration1/5 (20%) 0/6 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/9 (0%) 0/4 (0%) 0/3 (0%) 0/3 (0%) 0/7 (0%) 0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Sponsor intends to publish the results of the trial in collaboration with the Investigators.

Results Point of Contact

Name/TitleProject Manager
OrganizationCytokinetics,Inc.
Phone650-624-2918
Email
Responsible Party:
Cytokinetics
ClinicalTrials.gov Identifier:
NCT00343564
Other Study ID Numbers:
  • CY 2121
First Posted:
Jun 23, 2006
Last Update Posted:
Jan 13, 2020
Last Verified:
Jan 1, 2020