Trial Outcomes & Findings for Study of Pembrolizumab in Combination With Chemotherapy for Patients With Advanced Colorectal Cancer (NCT NCT02375672)
NCT ID: NCT02375672
Last Updated: 2022-02-16
Results Overview
Determine if pembrolizumab (MK-3475) in combination with chemotherapy improves median progression free survival (mPFS) compared to historical standards. Response Criteria - Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
From time of registration to the time of documented progression per RECIST 1.1 or subject death (estimate 14 months)
Results posted on
2022-02-16
Participant Flow
Participant milestones
| Measure |
Pembrolizumab (MK-3475) + mFOLFOX6
Following the safety run-in cohort:
mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks)
Pembrolizumab: Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks
mFOLFOX6: mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)
* Oxaliplatin 85 mg/m\^2 IV with
* Leucovorin 400 mg/m\^2 IV followed by
* 5FU 400 mg/m\^2 bolus and then 2400 mg/m\^2 via continuous infusion
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Pembrolizumab (MK-3475) + mFOLFOX6
Following the safety run-in cohort:
mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks)
Pembrolizumab: Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks
mFOLFOX6: mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)
* Oxaliplatin 85 mg/m\^2 IV with
* Leucovorin 400 mg/m\^2 IV followed by
* 5FU 400 mg/m\^2 bolus and then 2400 mg/m\^2 via continuous infusion
|
|---|---|
|
Overall Study
remain on follow up
|
20
|
Baseline Characteristics
Study of Pembrolizumab in Combination With Chemotherapy for Patients With Advanced Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab (MK-3475) + mFOLFOX6
n=30 Participants
Following the safety run-in cohort:
mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks)
Pembrolizumab: Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks
mFOLFOX6: mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)
* Oxaliplatin 85 mg/m\^2 IV with
* Leucovorin 400 mg/m\^2 IV followed by
* 5FU 400 mg/m\^2 bolus and then 2400 mg/m\^2 via continuous infusion
|
|---|---|
|
Age, Continuous
|
47.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
|
ECOG Performance Status
0
|
21 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
9 Participants
n=5 Participants
|
|
Stage at Presentation
I
|
1 Participants
n=5 Participants
|
|
Stage at Presentation
II A
|
2 Participants
n=5 Participants
|
|
Stage at Presentation
II B
|
0 Participants
n=5 Participants
|
|
Stage at Presentation
III A
|
0 Participants
n=5 Participants
|
|
Stage at Presentation
III B
|
2 Participants
n=5 Participants
|
|
Stage at Presentation
III C
|
3 Participants
n=5 Participants
|
|
Stage at Presentation
IV
|
22 Participants
n=5 Participants
|
|
Sites of Metastasis
Liver
|
22 participants
n=5 Participants
|
|
Sites of Metastasis
Lung
|
7 participants
n=5 Participants
|
|
Sites of Metastasis
Lymph Node
|
5 participants
n=5 Participants
|
|
Sites of Metastasis
Bone
|
2 participants
n=5 Participants
|
|
Sites of Metastasis
Ileum
|
3 participants
n=5 Participants
|
|
Sites of Metastasis
Peritoneum
|
3 participants
n=5 Participants
|
|
Sites of Metastasis
Other
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From time of registration to the time of documented progression per RECIST 1.1 or subject death (estimate 14 months)Determine if pembrolizumab (MK-3475) in combination with chemotherapy improves median progression free survival (mPFS) compared to historical standards. Response Criteria - Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Outcome measures
| Measure |
Pembrolizumab (MK-3475) + mFOLFOX6
n=30 Participants
Following the safety run-in cohort:
mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks)
Pembrolizumab: Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks
mFOLFOX6: mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)
* Oxaliplatin 85 mg/m\^2 IV with
* Leucovorin 400 mg/m\^2 IV followed by
* 5FU 400 mg/m\^2 bolus and then 2400 mg/m\^2 via continuous infusion
|
|---|---|
|
Median Progression Free Survival (mPFS)
|
8.8 months
Interval 7.7 to 11.3
|
SECONDARY outcome
Timeframe: Begin C1D1 and every 8 weeks thereafter (up to 24 months)To determine the number of patients who achieve complete response and partial response per irRC criteria.
Outcome measures
| Measure |
Pembrolizumab (MK-3475) + mFOLFOX6
n=30 Participants
Following the safety run-in cohort:
mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks)
Pembrolizumab: Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks
mFOLFOX6: mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)
* Oxaliplatin 85 mg/m\^2 IV with
* Leucovorin 400 mg/m\^2 IV followed by
* 5FU 400 mg/m\^2 bolus and then 2400 mg/m\^2 via continuous infusion
|
|---|---|
|
Disease Assessment for Objective Response Rate (ORR)
|
17 Participants
|
SECONDARY outcome
Timeframe: Begin C1D1 and every 8 weeks thereafter (up to 24 months) per RECIST 1.1 criteriaDisease control rate (DCR), defined as the sum of subjects with complete response, partial response and stable disease per RECIST 1.1 criteria.
Outcome measures
| Measure |
Pembrolizumab (MK-3475) + mFOLFOX6
n=30 Participants
Following the safety run-in cohort:
mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks)
Pembrolizumab: Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks
mFOLFOX6: mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)
* Oxaliplatin 85 mg/m\^2 IV with
* Leucovorin 400 mg/m\^2 IV followed by
* 5FU 400 mg/m\^2 bolus and then 2400 mg/m\^2 via continuous infusion
|
|---|---|
|
Disease Assessment for Disease Control Rate
|
30 Participants
|
SECONDARY outcome
Timeframe: Subject should be followed from time of registration till the time of subject death up to a maximum 35.5 monthsOverall Survival (OS) reported as number of subject alive at a median followup time of 19.9 months.
Outcome measures
| Measure |
Pembrolizumab (MK-3475) + mFOLFOX6
n=30 Participants
Following the safety run-in cohort:
mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks)
Pembrolizumab: Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks
mFOLFOX6: mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)
* Oxaliplatin 85 mg/m\^2 IV with
* Leucovorin 400 mg/m\^2 IV followed by
* 5FU 400 mg/m\^2 bolus and then 2400 mg/m\^2 via continuous infusion
|
|---|---|
|
Overall Survival (OS)
Alive
|
20 Participants
|
|
Overall Survival (OS)
Expired
|
10 Participants
|
SECONDARY outcome
Timeframe: Begin C1D1 and very 2 weeks (Day 1) for up to 24 monthsTo assess safety and tolerability of mFOLFOX6 and pembrolizumab (MK-3475) combination chemotherapy in patients with advanced colorectal cancer per CTCAE v4.0. Events are considered related if they assessed possible, probable or definite with study drug.
Outcome measures
| Measure |
Pembrolizumab (MK-3475) + mFOLFOX6
n=30 Participants
Following the safety run-in cohort:
mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks)
Pembrolizumab: Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks
mFOLFOX6: mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)
* Oxaliplatin 85 mg/m\^2 IV with
* Leucovorin 400 mg/m\^2 IV followed by
* 5FU 400 mg/m\^2 bolus and then 2400 mg/m\^2 via continuous infusion
|
|---|---|
|
Number of Patients With Grade 3 or Higher Treatment Related Adverse Event
|
15 Participants
|
Adverse Events
Pembrolizumab (MK-3475) + mFOLFOX6
Serious events: 7 serious events
Other events: 30 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Pembrolizumab (MK-3475) + mFOLFOX6
n=30 participants at risk
Following the safety run-in cohort:
mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks)
Pembrolizumab: Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks
mFOLFOX6: mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)
* Oxaliplatin 85 mg/m\^2 IV with
* Leucovorin 400 mg/m\^2 IV followed by
* 5FU 400 mg/m\^2 bolus and then 2400 mg/m\^2 via continuous infusion
|
|---|---|
|
Immune system disorders
ANAPHYLAXIS
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
COLITIS
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
DIARRHEA
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Endocrine disorders
ENDOCRINE DISORDERS
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
10.0%
3/30 • Number of events 3 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
General disorders
FEVER
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
NAUSEA
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
3.3%
1/30 • Number of events 2 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
VOMITING
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
Other adverse events
| Measure |
Pembrolizumab (MK-3475) + mFOLFOX6
n=30 participants at risk
Following the safety run-in cohort:
mFOLFOX6 Treatment D1 and D15 (every 2 weeks); Pembrolizumab (MK-3475) IV over 30 minutes (every 3 weeks)
Pembrolizumab: Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks
mFOLFOX6: mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)
* Oxaliplatin 85 mg/m\^2 IV with
* Leucovorin 400 mg/m\^2 IV followed by
* 5FU 400 mg/m\^2 bolus and then 2400 mg/m\^2 via continuous infusion
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
33.3%
10/30 • Number of events 16 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
26.7%
8/30 • Number of events 13 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
16.7%
5/30 • Number of events 6 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Immune system disorders
ALLERGIC REACTION
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
10.0%
3/30 • Number of events 3 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Blood and lymphatic system disorders
ANEMIA
|
16.7%
5/30 • Number of events 7 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Metabolism and nutrition disorders
ANOREXIA
|
26.7%
8/30 • Number of events 16 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Psychiatric disorders
ANXIETY
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
ASCITES
|
3.3%
1/30 • Number of events 3 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
23.3%
7/30 • Number of events 12 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
10.0%
3/30 • Number of events 4 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
BLOATING
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Blood and lymphatic system disorders
BLOOD AND LYMPHATIC SYSTEM DISORDERS
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
20.0%
6/30 • Number of events 11 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
BUTTOCK PAIN
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
General disorders
CHILLS
|
13.3%
4/30 • Number of events 6 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Eye disorders
CONJUNCTIVITIS
|
3.3%
1/30 • Number of events 2 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
CONSTIPATION
|
33.3%
10/30 • Number of events 15 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
10.0%
3/30 • Number of events 8 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Psychiatric disorders
DEPRESSION
|
10.0%
3/30 • Number of events 4 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
DIARRHEA
|
46.7%
14/30 • Number of events 31 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
DRY MOUTH
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Nervous system disorders
DYSESTHESIA
|
6.7%
2/30 • Number of events 3 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Nervous system disorders
DYSGEUSIA
|
20.0%
6/30 • Number of events 7 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
DYSPEPSIA
|
16.7%
5/30 • Number of events 5 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
10.0%
3/30 • Number of events 3 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
General disorders
EDEMA LIMBS
|
10.0%
3/30 • Number of events 4 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Eye disorders
EYE DISORDERS
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Eye disorders
EYE PAIN
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
General disorders
FACIAL PAIN
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
General disorders
FATIGUE
|
60.0%
18/30 • Number of events 63 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
FECAL INCONTINENCE
|
3.3%
1/30 • Number of events 2 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
General disorders
FEVER
|
16.7%
5/30 • Number of events 8 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
General disorders
GAIT DISTURBANCE
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS
|
10.0%
3/30 • Number of events 3 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
|
10.0%
3/30 • Number of events 3 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Psychiatric disorders
HALLUCINATIONS
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Nervous system disorders
HEADACHE
|
20.0%
6/30 • Number of events 8 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Renal and urinary disorders
HEMATURIA
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
HEMORRHOIDAL HEMORRHAGE
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
26.7%
8/30 • Number of events 35 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Vascular disorders
HYPERTENSION
|
10.0%
3/30 • Number of events 4 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Endocrine disorders
HYPERTHYROIDISM
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
10.0%
3/30 • Number of events 4 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
13.3%
4/30 • Number of events 4 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Vascular disorders
HYPOTENSION
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Endocrine disorders
HYPOTHYROIDISM
|
10.0%
3/30 • Number of events 4 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
General disorders
INFUSION RELATED REACTION
|
6.7%
2/30 • Number of events 3 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Psychiatric disorders
INSOMNIA
|
6.7%
2/30 • Number of events 4 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
LIP PAIN
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
10.0%
3/30 • Number of events 11 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
33.3%
10/30 • Number of events 15 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER
|
10.0%
3/30 • Number of events 4 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
3.3%
1/30 • Number of events 2 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
NAUSEA
|
73.3%
22/30 • Number of events 37 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDERS
|
20.0%
6/30 • Number of events 15 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
33.3%
10/30 • Number of events 21 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
ORAL PAIN
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
General disorders
PAIN
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.7%
2/30 • Number of events 3 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Infections and infestations
PAPULOPUSTULAR RASH
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Nervous system disorders
PARESTHESIA
|
13.3%
4/30 • Number of events 4 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
63.3%
19/30 • Number of events 68 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Investigations
PLATELET COUNT DECREASED
|
26.7%
8/30 • Number of events 26 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
10.0%
3/30 • Number of events 4 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
13.3%
4/30 • Number of events 4 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
13.3%
4/30 • Number of events 4 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
RECTAL HEMORRHAGE
|
16.7%
5/30 • Number of events 10 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
RECTAL PAIN
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
SINUS DISORDER
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Nervous system disorders
SINUS PAIN
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Infections and infestations
SINUSITIS
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
|
10.0%
3/30 • Number of events 3 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Nervous system disorders
SOMNOLENCE
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
10.0%
3/30 • Number of events 3 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Nervous system disorders
SYNCOPE
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.3%
1/30 • Number of events 1 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Gastrointestinal disorders
VOMITING
|
30.0%
9/30 • Number of events 13 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Investigations
WEIGHT GAIN
|
6.7%
2/30 • Number of events 2 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Investigations
WEIGHT LOSS
|
16.7%
5/30 • Number of events 5 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
16.7%
5/30 • Number of events 18 • Adverse events (AEs) was reported from the time of consent and until 30 days after last dose of study drug up to a maximum 108 weeks.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 were utilized for AE reporting
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place