Trial Outcomes & Findings for Study of Nab-Paclitaxel and Ramucirumab as Second-line Treatment for Patients With Metastatic Gastroesophageal Cancer (NCT NCT02317991)
NCT ID: NCT02317991
Last Updated: 2022-07-01
Results Overview
Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation in Solid Tumors Criteria (RECIST v1.1), or death on study from any cause. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Participants who are alive and free from disease progression were censored at the date of the last adequate tumor assessment. If no adequate post-treatment tumor assessments were obtained for participants, PFS will be censored on Day 1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
up to 1 year
Results posted on
2022-07-01
Participant Flow
Participant milestones
| Measure |
Nab-paclitaxel and Ramucirumab
All patients will receive 125 mg/m\^2 of nab-Paclitaxel intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle (weekly for 3 weeks, with 1 week of rest).
Patients will receive ramucirumab 8mg/kg IV in combination with nab-paclitaxel on Days 1 and 15 of the 28-day cycle.
nab-paclitaxel: nab-paclitaxel 125 mg/m\^2 IV
ramucirumab: Ramucirumab 8 mg/kg IV
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
65
|
Reasons for withdrawal
| Measure |
Nab-paclitaxel and Ramucirumab
All patients will receive 125 mg/m\^2 of nab-Paclitaxel intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle (weekly for 3 weeks, with 1 week of rest).
Patients will receive ramucirumab 8mg/kg IV in combination with nab-paclitaxel on Days 1 and 15 of the 28-day cycle.
nab-paclitaxel: nab-paclitaxel 125 mg/m\^2 IV
ramucirumab: Ramucirumab 8 mg/kg IV
|
|---|---|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Death
|
4
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Progressive Disease
|
41
|
Baseline Characteristics
Study of Nab-Paclitaxel and Ramucirumab as Second-line Treatment for Patients With Metastatic Gastroesophageal Cancer
Baseline characteristics by cohort
| Measure |
Nab-paclitaxel and Ramucirumab
n=65 Participants
All patients will receive 125 mg/m\^2 of nab-Paclitaxel intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle (weekly for 3 weeks, with 1 week of rest).
Patients will receive ramucirumab 8mg/kg IV in combination with nab-paclitaxel on Days 1 and 15 of the 28-day cycle.
nab-paclitaxel: nab-paclitaxel 125 mg/m\^2 IV
ramucirumab: Ramucirumab 8 mg/kg IV
|
|---|---|
|
Age, Continuous
|
63 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
65 Participants
n=99 Participants
|
|
Participants with HER2 positive status (confirmed by FISH)
|
12 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 1 yearPopulation: Full analysis set. All enrolled patients who have received at least one dose of study treatment and have a baseline tumor assessment.
Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation in Solid Tumors Criteria (RECIST v1.1), or death on study from any cause. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Participants who are alive and free from disease progression were censored at the date of the last adequate tumor assessment. If no adequate post-treatment tumor assessments were obtained for participants, PFS will be censored on Day 1.
Outcome measures
| Measure |
Nab-paclitaxel and Ramucirumab
n=65 Participants
All patients will receive 125 mg/m\^2 of nab-Paclitaxel intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle (weekly for 3 weeks, with 1 week of rest).
Patients will receive ramucirumab 8mg/kg IV in combination with nab-paclitaxel on Days 1 and 15 of the 28-day cycle.
nab-paclitaxel: nab-paclitaxel 125 mg/m\^2 IV
ramucirumab: Ramucirumab 8 mg/kg IV
|
|---|---|
|
Progression-Free Survival (PFS)
|
3.8 months
Interval 3.4 to 5.7
|
SECONDARY outcome
Timeframe: every 8 weeks up to 1 yearPopulation: Full analysis set. All enrolled patients who have received at least one dose of study treatment and have a baseline tumor assessment.
ORR is defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR), i.e., two CRs and/or PRs at least 4 weeks apart, according to the RECIST v1.1 criteria. CR=disappearance of all target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Nab-paclitaxel and Ramucirumab
n=65 Participants
All patients will receive 125 mg/m\^2 of nab-Paclitaxel intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle (weekly for 3 weeks, with 1 week of rest).
Patients will receive ramucirumab 8mg/kg IV in combination with nab-paclitaxel on Days 1 and 15 of the 28-day cycle.
nab-paclitaxel: nab-paclitaxel 125 mg/m\^2 IV
ramucirumab: Ramucirumab 8 mg/kg IV
|
|---|---|
|
Overall Response Rate (ORR)
|
20 percentage of participants
Interval 10.3 to 29.7
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: Full analysis set. All enrolled patients who have received at least one dose of study treatment and have a baseline tumor assessment.
TTP is defined as the time from the first day of study drug administration (Day 1) to objective disease progression as defined by the RECIST v1.1 criteria. Patients who are alive and free from disease progression will be censored at the date of the last adequate tumor assessment. If no adequate post-treatment tumor assessments were obtained for a patient, TTP will be censored on Day 1. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or unequivocal progression of non-target lesions or the appearance of one or more new lesions.
Outcome measures
| Measure |
Nab-paclitaxel and Ramucirumab
n=65 Participants
All patients will receive 125 mg/m\^2 of nab-Paclitaxel intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle (weekly for 3 weeks, with 1 week of rest).
Patients will receive ramucirumab 8mg/kg IV in combination with nab-paclitaxel on Days 1 and 15 of the 28-day cycle.
nab-paclitaxel: nab-paclitaxel 125 mg/m\^2 IV
ramucirumab: Ramucirumab 8 mg/kg IV
|
|---|---|
|
Time to Progression (TTP)
|
4.5 months
Interval 3.5 to 6.4
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: Full analysis set. All enrolled patients who have received at least one dose of study treatment and have a baseline tumor assessment.
OS is defined as the time from the first treatment until date of death due to any cause. In the absence of confirmation of death or lack of data beyond follow-up period, the survival time was censored to last date the participant was known to be alive.
Outcome measures
| Measure |
Nab-paclitaxel and Ramucirumab
n=65 Participants
All patients will receive 125 mg/m\^2 of nab-Paclitaxel intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle (weekly for 3 weeks, with 1 week of rest).
Patients will receive ramucirumab 8mg/kg IV in combination with nab-paclitaxel on Days 1 and 15 of the 28-day cycle.
nab-paclitaxel: nab-paclitaxel 125 mg/m\^2 IV
ramucirumab: Ramucirumab 8 mg/kg IV
|
|---|---|
|
Overall Survival (OS)
|
8 months
Interval 6.4 to 10.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For duration of treatment, up to of 6 monthsPopulation: Full analysis set. All enrolled patients who have received at least one dose of study treatment and have a baseline tumor assessment.
Adverse events will be graded utilizing the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
Outcome measures
| Measure |
Nab-paclitaxel and Ramucirumab
n=65 Participants
All patients will receive 125 mg/m\^2 of nab-Paclitaxel intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle (weekly for 3 weeks, with 1 week of rest).
Patients will receive ramucirumab 8mg/kg IV in combination with nab-paclitaxel on Days 1 and 15 of the 28-day cycle.
nab-paclitaxel: nab-paclitaxel 125 mg/m\^2 IV
ramucirumab: Ramucirumab 8 mg/kg IV
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
|
62 Participants
|
Adverse Events
Nab-paclitaxel and Ramucirumab
Serious events: 30 serious events
Other events: 62 other events
Deaths: 51 deaths
Serious adverse events
| Measure |
Nab-paclitaxel and Ramucirumab
n=65 participants at risk
All patients will receive 125 mg/m\^2 of nab-Paclitaxel intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle (weekly for 3 weeks, with 1 week of rest).
Patients will receive ramucirumab 8mg/kg IV in combination with nab-paclitaxel on Days 1 and 15 of the 28-day cycle.
nab-paclitaxel: nab-paclitaxel 125 mg/m\^2 IV
ramucirumab: Ramucirumab 8 mg/kg IV
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.6%
3/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Ascites
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
1/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Ileus
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Nausea
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
2/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Death
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Fatigue
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Gait disturbance
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Oedema peripheral
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Bacteraemia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Clostridium difficile colitis
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Diverticulitis
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Influenza
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Pneumonia
|
9.2%
6/65 • Number of events 7 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Sepsis
|
7.7%
5/65 • Number of events 5 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Septic shock
|
4.6%
3/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Blood pressure increased
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Influenza B virus test positive
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Psychiatric disorders
Confusional state
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.5%
1/65 • Number of events 4 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Surgical and medical procedures
Intramedullary rod insertion
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Vascular disorders
Hypertension
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
Other adverse events
| Measure |
Nab-paclitaxel and Ramucirumab
n=65 participants at risk
All patients will receive 125 mg/m\^2 of nab-Paclitaxel intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle (weekly for 3 weeks, with 1 week of rest).
Patients will receive ramucirumab 8mg/kg IV in combination with nab-paclitaxel on Days 1 and 15 of the 28-day cycle.
nab-paclitaxel: nab-paclitaxel 125 mg/m\^2 IV
ramucirumab: Ramucirumab 8 mg/kg IV
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.5%
12/65 • Number of events 33 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
4.6%
3/65 • Number of events 4 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.3%
8/65 • Number of events 13 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Blood and lymphatic system disorders
Neutropenia
|
44.6%
29/65 • Number of events 94 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.7%
5/65 • Number of events 10 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Ear and labyrinth disorders
Deafness
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Ear and labyrinth disorders
Vestibular disorder
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Eye disorders
Eye discharge
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Eye disorders
Eyelid oedema
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Eye disorders
Periorbital oedema
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Eye disorders
Vision blurred
|
1.5%
1/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Abdominal distension
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
13/65 • Number of events 17 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.3%
8/65 • Number of events 10 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Ascites
|
6.2%
4/65 • Number of events 4 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Cheilitis
|
1.5%
1/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Constipation
|
16.9%
11/65 • Number of events 14 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
13/65 • Number of events 26 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Dry mouth
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Dysphagia
|
4.6%
3/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.6%
3/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Gingival ulceration
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Haematemesis
|
1.5%
1/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Haematochezia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Lip haemorrhage
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Lip ulceration
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Nausea
|
26.2%
17/65 • Number of events 28 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Oesophageal pain
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Oral pain
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Stomatitis
|
13.8%
9/65 • Number of events 11 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Toothache
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Gastrointestinal disorders
Vomiting
|
16.9%
11/65 • Number of events 18 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Asthenia
|
9.2%
6/65 • Number of events 7 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Axillary pain
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Catheter site erythema
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Chest pain
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Chills
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Facial pain
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Fatigue
|
44.6%
29/65 • Number of events 54 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Localised oedema
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Malaise
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Mucosal inflammation
|
13.8%
9/65 • Number of events 16 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Non-cardiac chest pain
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Oedema
|
3.1%
2/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Oedema peripheral
|
21.5%
14/65 • Number of events 18 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Pain
|
4.6%
3/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Performance status decreased
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Pyrexia
|
10.8%
7/65 • Number of events 10 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
General disorders
Swelling face
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Hepatobiliary disorders
Biliary obstruction
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Hepatobiliary disorders
Jaundice
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Abscess oral
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Bronchitis
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Candida infection
|
4.6%
3/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Catheter site infection
|
6.2%
4/65 • Number of events 4 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Colonic abscess
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Device related infection
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Fungal skin infection
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Genital herpes
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Genital herpes simplex
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Gingivitis
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Herpes ophthalmic
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Hordeolum
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Nasal herpes
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Oral candidiasis
|
6.2%
4/65 • Number of events 4 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Oral herpes
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Penile infection
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Pneumonia
|
1.5%
1/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Septic shock
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Sinusitis
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Staphylococcal skin infection
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Tooth infection
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
4/65 • Number of events 4 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Urinary tract infection
|
7.7%
5/65 • Number of events 6 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Injury, poisoning and procedural complications
Contusion
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Injury, poisoning and procedural complications
Incision site pain
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.6%
3/65 • Number of events 6 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Injury, poisoning and procedural complications
Stoma site ulcer
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Injury, poisoning and procedural complications
Sunburn
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
2/65 • Number of events 4 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
2/65 • Number of events 5 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Blood alkaline phosphatase increased
|
4.6%
3/65 • Number of events 7 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Blood bilirubin increased
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Blood folate decreased
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Blood iron decreased
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Blood magnesium decreased
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Blood potassium decreased
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Clostridium test positive
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Colonoscopy
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
International normalised ratio increased
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Neutrophil count decreased
|
12.3%
8/65 • Number of events 15 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Oesophagogastroduodenoscopy
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Platelet count decreased
|
3.1%
2/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Quality of life decreased
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Weight decreased
|
24.6%
16/65 • Number of events 20 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
Weight increased
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Investigations
White blood cell count decreased
|
1.5%
1/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Cachexia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Decreased appetite
|
36.9%
24/65 • Number of events 31 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
13/65 • Number of events 16 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Fluid retention
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.6%
3/65 • Number of events 4 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.1%
2/65 • Number of events 4 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
5/65 • Number of events 8 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.3%
8/65 • Number of events 10 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.1%
2/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.1%
2/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
4/65 • Number of events 6 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.6%
3/65 • Number of events 4 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.1%
2/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.6%
3/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.5%
1/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
4/65 • Number of events 4 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
1.5%
1/65 • Number of events 6 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Aphasia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Balance disorder
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Cluster headache
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Depressed level of consciousness
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Dizziness
|
12.3%
8/65 • Number of events 8 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Dysgeusia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Headache
|
7.7%
5/65 • Number of events 6 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Neuropathy peripheral
|
23.1%
15/65 • Number of events 30 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Paraesthesia
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.1%
2/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.8%
7/65 • Number of events 12 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Sensory loss
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Syncope
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Taste disorder
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Nervous system disorders
Tremor
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Product Issues
Device malfunction
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Product Issues
Device occlusion
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Psychiatric disorders
Agitation
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Psychiatric disorders
Anxiety
|
7.7%
5/65 • Number of events 5 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Psychiatric disorders
Depression
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Psychiatric disorders
Insomnia
|
4.6%
3/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Psychiatric disorders
Mental status changes
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Psychiatric disorders
Panic attack
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Renal and urinary disorders
Chromaturia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Renal and urinary disorders
Haematuria
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Renal and urinary disorders
Nocturia
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Renal and urinary disorders
Proteinuria
|
13.8%
9/65 • Number of events 13 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Renal and urinary disorders
Urinary retention
|
3.1%
2/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Reproductive system and breast disorders
Prostatomegaly
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.6%
3/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.6%
3/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.3%
8/65 • Number of events 8 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
21.5%
14/65 • Number of events 14 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
5/65 • Number of events 6 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.6%
3/65 • Number of events 5 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
4.6%
3/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
24.6%
16/65 • Number of events 17 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Blister
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
3.1%
2/65 • Number of events 2 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.6%
3/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Nail bed bleeding
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
4.6%
3/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
4.6%
3/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
2/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
4/65 • Number of events 6 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.6%
3/65 • Number of events 3 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Surgical and medical procedures
Abscess drainage
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Surgical and medical procedures
Gastrostomy tube removal
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Surgical and medical procedures
Incisional drainage
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Vascular disorders
Embolism
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Vascular disorders
Haematoma
|
1.5%
1/65 • Number of events 1 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Vascular disorders
Hypertension
|
12.3%
8/65 • Number of events 16 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
|
Vascular disorders
Hypotension
|
10.8%
7/65 • Number of events 9 • For the duration of study treatment, up to 6 months for Serious Adverse Events and Other Adverse Events. Until study follow-up discontinuation, an average of 1 year for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
|
Additional Information
Sarah Cannon Development Innovations, LLC
Sarah Cannon Development Innovations, LLC
Phone: 844-710-6157
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60