Trial Outcomes & Findings for Safety and Efficacy Clinical Study of SNS-595 in Patients With Advanced Small Cell Lung Cancer (NCT NCT00298896)
NCT ID: NCT00298896
Last Updated: 2018-07-26
Results Overview
Objective tumor response rate based on the RECIST criteria for target lesions as assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), at least a 20% increase in the sum of the LD of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Overall Response (OR) = CR + PR
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
up to 6 months
Results posted on
2018-07-26
Participant Flow
Participant milestones
| Measure |
SNS-595
SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
SNS-595
SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Intercurrent Illness
|
1
|
|
Overall Study
Disease Progression
|
41
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Assigned to treatment in error
|
1
|
Baseline Characteristics
Safety and Efficacy Clinical Study of SNS-595 in Patients With Advanced Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
SNS-595
n=55 Participants
SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.
|
|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 9.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
14 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: Efficacy Analysis Population
Objective tumor response rate based on the RECIST criteria for target lesions as assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), at least a 20% increase in the sum of the LD of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Overall Response (OR) = CR + PR
Outcome measures
| Measure |
SNS-595
n=47 Participants
SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.
|
|---|---|
|
Objective Response Rate
|
3 Participants
|
SECONDARY outcome
Timeframe: upto 6 monthsPopulation: Efficacy Analysis Set
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started), classified as CR, PR, SD or PD per RECIST criteria.
Outcome measures
| Measure |
SNS-595
n=47 Participants
SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.
|
|---|---|
|
Best Overall Response
Complete Response
|
1 Participants
|
|
Best Overall Response
Partial Response
|
2 Participants
|
|
Best Overall Response
Progressive Disease
|
31 Participants
|
|
Best Overall Response
Stable Disease
|
13 Participants
|
Adverse Events
SNS-595
Serious events: 9 serious events
Other events: 52 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
SNS-595
n=54 participants at risk
SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.
SNS-595
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.4%
4/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Sudden death
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Infections and infestations
Pneumonia
|
5.6%
3/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Nervous system disorders
Leukoencephalopathy
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
Other adverse events
| Measure |
SNS-595
n=54 participants at risk
SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.
SNS-595
|
|---|---|
|
Gastrointestinal disorders
Odynophagia
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Gastrointestinal disorders
Oral discomfort
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Gastrointestinal disorders
Stomatitis
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Gastrointestinal disorders
Vomiting
|
24.1%
13/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Asthenia
|
16.7%
9/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
9/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Blood and lymphatic system disorders
Neutropenia
|
38.9%
21/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.4%
4/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Blood and lymphatic system disorders
WBC abnormal
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Cardiac disorders
Palpitations
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Cardiac disorders
Tachycardia
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Ear and labyrinth disorders
Vertigo
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Eye disorders
Blindness transient
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Eye disorders
Dry eye
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Eye disorders
Vision blurred
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
3/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Gastrointestinal disorders
Breath odour
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Gastrointestinal disorders
Constipation
|
29.6%
16/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Gastrointestinal disorders
Diarrhoea
|
18.5%
10/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Gastrointestinal disorders
Dyspepsia
|
13.0%
7/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Gastrointestinal disorders
Dysphagia
|
7.4%
4/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Gastrointestinal disorders
Nausea
|
51.9%
28/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Chest discomfort
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Chills
|
7.4%
4/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Disease progression
|
11.1%
6/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Fatigue
|
72.2%
39/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Gait disturbances
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
General physical health deterioration
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Hyperhidrosis
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Influenza like illness
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Lethargy
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Mucosal inflammation
|
7.4%
4/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Nodule
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Non-cardiac chest pain
|
14.8%
8/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Oedema peripheral
|
5.6%
3/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Pain
|
7.4%
4/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Pitting oedema
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
General disorders
Pyrexia
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Hepatobiliary disorders
Hepatomegaly
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Hepatobiliary disorders
Liver disorder
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Immune system disorders
Seasonal allergy
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Infections and infestations
Bronchitis
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Infections and infestations
Herpes simplex
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Infections and infestations
Laryngitis
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Infections and infestations
Localised infection
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Infections and infestations
Oral candidiasis
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Infections and infestations
Otitis media
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Infections and infestations
Sinusitis
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Infections and infestations
Urinary tract infection
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Injury, poisoning and procedural complications
Blister
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Investigations
Breath sounds abnormal
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Investigations
Weight decreased
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Metabolism and nutrition disorders
Anorexia
|
18.5%
10/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Metabolism and nutrition disorders
Dehydration
|
9.3%
5/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Metabolism and nutrition disorders
Hypercalcaemia of malignancy
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.4%
4/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.3%
5/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Metabolism and nutrition disorders
Polydipsia
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.0%
7/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
12/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Nervous system disorders
Akathisia
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Nervous system disorders
Balance disorder
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Nervous system disorders
Cognitive disorder
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Nervous system disorders
Dizziness
|
11.1%
6/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Nervous system disorders
Dysgeusia
|
13.0%
7/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Nervous system disorders
Headache
|
14.8%
8/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Nervous system disorders
Memory impairment
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Nervous system disorders
Neuropathy
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Nervous system disorders
Neuropathy peripheral
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Nervous system disorders
Paraesthesia
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Nervous system disorders
Somnolence
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Nervous system disorders
Tremor
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Psychiatric disorders
Agitation
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Psychiatric disorders
Anxiety
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Psychiatric disorders
Confusional state
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Psychiatric disorders
Depression
|
5.6%
3/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Psychiatric disorders
Insomnia
|
9.3%
5/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Psychiatric disorders
Restlessness
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Renal and urinary disorders
Bladder distension
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Renal and urinary disorders
Chromaturia
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Renal and urinary disorders
Pollakiuria
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Renal and urinary disorders
Proteinuria
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Renal and urinary disorders
Pyuria
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Renal and urinary disorders
Renal failure
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Renal and urinary disorders
Urinary retention
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Renal and urinary disorders
Urine abnormality
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.4%
11/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.6%
3/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.9%
14/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
3/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.4%
4/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Plerual effusion
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.3%
5/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
3/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Skin and subcutaneous tissue disorders
Hair disorder
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
6/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Vascular disorders
Hypertension
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Vascular disorders
Hypotension
|
3.7%
2/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Vascular disorders
Orthostatic hypotension
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
|
Vascular disorders
Thrombophlebitis
|
1.9%
1/54 • From time of first dosing of study treatment (up to 6 cycles of 21 days each) to 28 days post last treatment, i.e., approximately 5.1 months.
One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).
|
Additional Information
Mike Johnston, Senior Director Regulatory Affairs
Sunesis Pharmaceuticals, Inc.
Phone: (650) 266-3727
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60