Trial Outcomes & Findings for A Phase I Imaging and Pharmacodynamic Trial of CS-1008 in Patients With Metastatic Colorectal Cancer (NCT NCT01220999)
NCT ID: NCT01220999
Last Updated: 2022-10-28
Results Overview
Tumor localization was assessed using gamma camera imaging performed after the initial infusion of 111\^In-CS-1008 on Day 1 and then on Days 2, 4/5, 7/8, and 11/12 (collectively, "After Day 1 Infusion" in the table) and after the second infusion of 111\^In-CS-1008 on Day 36 and then on Days 37, 39/40, and 42/43 (collectively, "After Day 36 Infusion" in the table). Dosimetry calculations were performed to determine the tumor localization properties of 111\^In-CS-1008. Calculation of whole body dose and doses to individual organs by 111\^In-CS-1008 were performed based on conjugate view images obtained from quantitative whole body images obtained at multiple time points. MIRD formalism was used in the calculation of doses.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
Up to 43 days
Results posted on
2022-10-28
Participant Flow
Participant milestones
| Measure |
Cohort 1
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
5
|
3
|
5
|
|
Overall Study
COMPLETED
|
2
|
4
|
4
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Overall Study
Progressive disease
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase I Imaging and Pharmacodynamic Trial of CS-1008 in Patients With Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=5 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=5 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.0 years
n=5 Participants
|
60.5 years
n=7 Participants
|
65.0 years
n=5 Participants
|
65.0 years
n=4 Participants
|
63.0 years
n=21 Participants
|
64.0 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
Australia
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
|
0.5 units on a scale
n=5 Participants
|
0.0 units on a scale
n=7 Participants
|
1.0 units on a scale
n=5 Participants
|
1.0 units on a scale
n=4 Participants
|
1.0 units on a scale
n=21 Participants
|
1.0 units on a scale
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 43 daysPopulation: The population comprises all subjects who completed study requirements through Cycle 1 (Day 43). One patient in Cohort 3 was prematurely withdrawn from the study on Day 36 due to symptomatic deterioration secondary to progressive disease (radiologically documented) and did not complete Cycle 1.
Tumor localization was assessed using gamma camera imaging performed after the initial infusion of 111\^In-CS-1008 on Day 1 and then on Days 2, 4/5, 7/8, and 11/12 (collectively, "After Day 1 Infusion" in the table) and after the second infusion of 111\^In-CS-1008 on Day 36 and then on Days 37, 39/40, and 42/43 (collectively, "After Day 36 Infusion" in the table). Dosimetry calculations were performed to determine the tumor localization properties of 111\^In-CS-1008. Calculation of whole body dose and doses to individual organs by 111\^In-CS-1008 were performed based on conjugate view images obtained from quantitative whole body images obtained at multiple time points. MIRD formalism was used in the calculation of doses.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=5 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=5 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Number of Subjects With Tumor Uptake of 111^In-CS-1008 in Target Lesions Based on Gamma Camera Imaging Following the Day 1 and Day 36 Infusions
After Day 1 infusion: High, Specific Uptake
|
0 participants
|
3 participants
|
3 participants
|
3 participants
|
3 participants
|
|
Number of Subjects With Tumor Uptake of 111^In-CS-1008 in Target Lesions Based on Gamma Camera Imaging Following the Day 1 and Day 36 Infusions
After Day 1 infusion: No Uptake
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
2 participants
|
|
Number of Subjects With Tumor Uptake of 111^In-CS-1008 in Target Lesions Based on Gamma Camera Imaging Following the Day 1 and Day 36 Infusions
After Day 36 infusion: High, Specific Uptake
|
0 participants
|
3 participants
|
3 participants
|
3 participants
|
3 participants
|
|
Number of Subjects With Tumor Uptake of 111^In-CS-1008 in Target Lesions Based on Gamma Camera Imaging Following the Day 1 and Day 36 Infusions
After Day 36 infusion: No Uptake
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Up to 43 daysPopulation: The population comprises all subjects who completed study requirements through Cycle 1 (Day 43) and had tumor uptake.
Tumor localization was assessed using gamma camera imaging performed on Days 7/8 and 42/43. Dosimetry calculations were performed to determine the tumor localization properties of 111\^In-CS-1008. Calculation of whole body dose and doses to individual organs by 111\^In-CS-1008 were performed based on conjugate view images obtained from quantitative whole body images obtained at multiple time points. MIRD formalism was used in the calculation of doses.
Outcome measures
| Measure |
Cohort 1
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Mean Tumor Uptake of 111^In-CS-1008 Based on Gamma Camera Imaging Following the Day 1 and Day 36 Infusions
Post-infusion tumor uptake: Day 7/8
|
—
|
0.0042 % of injected dose/g of organ
Standard Deviation 0.0013
|
0.0063 % of injected dose/g of organ
Standard Deviation 0.0004
|
0.0044 % of injected dose/g of organ
Standard Deviation 0.0015
|
0.0043 % of injected dose/g of organ
Standard Deviation 0.0006
|
|
Mean Tumor Uptake of 111^In-CS-1008 Based on Gamma Camera Imaging Following the Day 1 and Day 36 Infusions
Post-infusion tumor uptake: Day 42/43
|
—
|
0.0045 % of injected dose/g of organ
Standard Deviation 0.0005
|
0.0061 % of injected dose/g of organ
Standard Deviation 0.0011
|
0.0044 % of injected dose/g of organ
Standard Deviation 0.0012
|
0.0036 % of injected dose/g of organ
Standard Deviation 0.0007
|
PRIMARY outcome
Timeframe: Up to 36 daysPopulation: The population comprises all subjects who received Day 1 of study treatment and had post-infusion PK samples evaluable by gamma scintillation counting.
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 1 infusion at the following time points: Day 1 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 2 (24 hours after Day 1 infusion), Day 4/5, Day 7/8 (pre-infusion and 5 minutes post-infusion if on Day 8), Day 11/12, and Day 36 (pre-infusion).
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=5 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Mean 111^In-CS-1008 Serum Half-life by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008
Initial half-life
|
14.51 hours
Standard Deviation 5.95
|
21.52 hours
Standard Deviation 5.76
|
5.29 hours
Standard Deviation 4.76
|
10.45 hours
Standard Deviation 6.85
|
14.73 hours
Standard Deviation 4.72
|
|
Mean 111^In-CS-1008 Serum Half-life by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008
Terminal half-life
|
284.76 hours
Standard Deviation 0.38
|
264.89 hours
Standard Deviation 122.12
|
163.08 hours
Standard Deviation 39.86
|
243.39 hours
Standard Deviation 52.21
|
247.5 hours
Standard Deviation 52.9
|
PRIMARY outcome
Timeframe: Up to 36 daysPopulation: The population comprises all subjects who received Day 1 of study treatment and had post-infusion PK samples evaluable by gamma scintillation counting.
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 1 infusion at the following time points: Day 1 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 2 (24 hours after Day 1 infusion), Day 4/5, Day 7/8 (pre-infusion and 5 minutes post-infusion if on Day 8), Day 11/12, and Day 36 (pre-infusion).
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=5 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Mean 111^In-CS-1008 Serum Volume of Central Compartment by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008
|
3209.83 mL
Standard Deviation 321.96
|
2592.36 mL
Standard Deviation 303.21
|
3329.11 mL
Standard Deviation 624.49
|
2658.70 mL
Standard Deviation 112.60
|
4037 mL
Standard Deviation 425
|
PRIMARY outcome
Timeframe: Up to 36 daysPopulation: The population comprises all subjects who received Day 1 of study treatment and had post-infusion PK samples evaluable by gamma scintillation counting.
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 1 infusion at the following time points: Day 1 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 2 (24 hours after Day 1 infusion), Day 4/5, Day 7/8 (pre-infusion and 5 minutes post-infusion if on Day 8), Day 11/12, and Day 36 (pre-infusion).
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=5 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Mean 111^In-CS-1008 Serum Area Under the Curve by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008
|
986.58 hr*μg/mL
Standard Deviation 125.11
|
5706.38 hr*μg/mL
Standard Deviation 2632.72
|
8386.68 hr*μg/mL
Standard Deviation 855.70
|
18714.05 hr*μg/mL
Standard Deviation 1511.25
|
28492 hr*μg/mL
Standard Deviation 1598
|
PRIMARY outcome
Timeframe: Up to 36 daysPopulation: The population comprises all subjects who received Day 1 of study treatment and had post-infusion PK samples evaluable by gamma scintillation counting.
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 1 infusion at the following time points: Day 1 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 2 (24 hours after Day 1 infusion), Day 4/5, Day 7/8 (pre-infusion and 5 minutes post-infusion if on Day 8), Day 11/12, and Day 36 (pre-infusion).
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=5 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Mean 111^In-CS-1008 Serum Total Clearance by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008
|
14.92 mL/hr
Standard Deviation 2.5
|
12.31 mL/hr
Standard Deviation 3.38
|
18.23 mL/hr
Standard Deviation 0.51
|
12 mL/hr
Standard Deviation 2.03
|
18.52 mL/hr
Standard Deviation 2.61
|
PRIMARY outcome
Timeframe: Up to 36 daysPopulation: The population comprises all subjects who received Day 1 of study treatment and had post-infusion PK samples evaluable by gamma scintillation counting.
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 1 infusion at the following time points: Day 1 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 2 (24 hours after Day 1 infusion), Day 4/5, Day 7/8 (pre-infusion and 5 minutes post-infusion if on Day 8), Day 11/12, and Day 36 (pre-infusion).
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=5 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Mean 111^In-CS-1008 Serum Maximum Concentration by Gamma Counting Following the Day 1 Infusion of 111^In-CS-1008
|
4.59 μg/mL
Standard Deviation 0.89
|
24.6 μg/mL
Standard Deviation 3.75
|
47.29 μg/mL
Standard Deviation 10.19
|
84.14 μg/mL
Standard Deviation 11
|
131.3 μg/mL
Standard Deviation 20.1
|
PRIMARY outcome
Timeframe: Up to 50 daysPopulation: The population comprises all subjects who completed study requirements through Cycle 1 (Day 43) and had post-infusion PK samples evaluable by gamma scintillation counting.
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 36 infusion at the following time points: Day 36 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 37 (24 hours after Day 36 infusion), Day 39/40, Day 43 (pre-infusion and 5 minutes post-infusion), and at the End of Cycle visit (Days 44-50).
Outcome measures
| Measure |
Cohort 1
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Mean 111^In-CS-1008 Serum Half-life by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008
Initial half-life
|
—
|
12.21 hours
Standard Deviation 6.13
|
15.84 hours
Standard Deviation 13.25
|
15.01 hours
Standard Deviation 3.48
|
15.56 hours
Standard Deviation 4.17
|
|
Mean 111^In-CS-1008 Serum Half-life by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008
Terminal half-life
|
—
|
186.2 hours
Standard Deviation 36.3
|
247.5 hours
Standard Deviation 109.3
|
347 hours
Standard Deviation 202
|
260.5 hours
Standard Deviation 51.1
|
PRIMARY outcome
Timeframe: Up to 50 daysPopulation: The population comprises all subjects who completed study requirements through Cycle 1 (Day 43) and had post-infusion PK samples evaluable by gamma scintillation counting.
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 36 infusion at the following time points: Day 36 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 37 (24 hours after Day 36 infusion), Day 39/40, Day 43 (pre-infusion and 5 minutes post-infusion), and at the End of Cycle visit (Days 44-50).
Outcome measures
| Measure |
Cohort 1
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Mean 111^In-CS-1008 Serum Volume of Central Compartment by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008
|
—
|
2510 mL
Standard Deviation 313
|
3272 mL
Standard Deviation 733
|
2742 mL
Standard Deviation 304
|
3985 mL
Standard Deviation 660
|
PRIMARY outcome
Timeframe: Up to 50 daysPopulation: The population comprises all subjects who completed study requirements through Cycle 1 (Day 43) and had post-infusion PK samples evaluable by gamma scintillation counting.
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 36 infusion at the following time points: Day 36 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 37 (24 hours after Day 36 infusion), Day 39/40, Day 43 (pre-infusion and 5 minutes post-infusion), and at the End of Cycle visit (Days 44-50).
Outcome measures
| Measure |
Cohort 1
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Mean 111^In-CS-1008 Serum Area Under the Curve by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008
|
—
|
9013 hr*μg/mL
Standard Deviation 1629
|
9772 hr*μg/mL
Standard Deviation 626
|
10990 hr*μg/mL
Standard Deviation 3205
|
10465 hr*μg/mL
Standard Deviation 3286
|
PRIMARY outcome
Timeframe: Up to 50 daysPopulation: The population comprises all subjects who completed study requirements through Cycle 1 (Day 43) and had post-infusion PK samples evaluable by gamma scintillation counting.
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 36 infusion at the following time points: Day 36 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 37 (24 hours after Day 36 infusion), Day 39/40, Day 43 (pre-infusion and 5 minutes post-infusion), and at the End of Cycle visit (Days 44-50).
Outcome measures
| Measure |
Cohort 1
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Mean 111^In-CS-1008 Serum Total Clearance by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008
|
—
|
14.11 mL/hr
Standard Deviation 1.35
|
15.29 mL/hr
Standard Deviation 2
|
10.73 mL/hr
Standard Deviation 4.43
|
19.00 mL/hr
Standard Deviation 6.48
|
PRIMARY outcome
Timeframe: Up to 50 daysPopulation: The population comprises all subjects who completed study requirements through Cycle 1 (Day 43) and had post-infusion PK samples evaluable by gamma scintillation counting.
The serum PK of CS-1008 was evaluated by gamma scintillation counting to assess serum radioactivity (111\^In-CS-1008) and CS-1008 protein concentration following the Day 36 infusion at the following time points: Day 36 (pre-infusion and 5 minutes and 1, 2, and 4 hours post-infusion), Day 37 (24 hours after Day 36 infusion), Day 39/40, Day 43 (pre-infusion and 5 minutes post-infusion), and at the End of Cycle visit (Days 44-50).
Outcome measures
| Measure |
Cohort 1
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Mean 111^In-CS-1008 Serum Maximum Concentration by Gamma Counting Following the Day 36 Infusion of 111^In-CS-1008
|
—
|
51.08 μg/mL
Standard Deviation 11.62
|
47.10 μg/mL
Standard Deviation 12.07
|
40.98 μg/mL
Standard Deviation 9.77
|
47.38 μg/mL
Standard Deviation 9.99
|
SECONDARY outcome
Timeframe: Up to 7 monthsPopulation: The population comprises all subjects who received at least 1 dose of study treatment and had at least 1 applicable post-baseline response evaluation.
Tumor responses were evaluated using appropriate imaging and categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, at Screening, at the end of every odd-numbered cycle (i.e., Cycles 1, 3, and 5, as applicable), and at the time of treatment discontinuation. Per RECIST 1.1, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria (Eisenhauer et al. Eur J Cancer 2009;45:228-47).
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=5 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=5 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Number of Subjects With Best Overall Tumor Response
PR
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Best Overall Tumor Response
SD
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Best Overall Tumor Response
PD
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 50 daysPopulation: The population comprises all subjects who received at least 1 dose of study treatment and had at least 1 applicable post-baseline response evaluation.
Metabolic response to CS-1008 was assessed by fluorodeoxyglucose positron emission tomography (18\^F-FDG PET) at Screening, Day 15, and at the End of Cycle 1/End of Study visit (Days 44-50). For each FDG-PET performed, the maximum standardized uptake value (SUVmax) corrected for body weight for all target lesions \>2 cm identified on CT imaging was calculated using region of interest (ROI). The ROI was determined with the aid of the anatomical detail provided by the CT scan. Tumor metabolic response to CS-1008 was assessed by 18\^F-FDG PET/CT calculated using the target lesion with the greatest baseline SUVmax, and was categorized according to the European Organization for Research and Treatment of Cancer (EORTC) guidelines (Young et al. Eur J Cancer 1999;35:1773-82).
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=5 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=3 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=5 Participants
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Number of Subjects With Best Overall Metabolic Response
Metabolic PR
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Best Overall Metabolic Response
Metabolic SD
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Best Overall Metabolic Response
Metabolic PD
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=2 participants at risk
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 participants at risk
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=5 participants at risk
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=3 participants at risk
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=5 participants at risk
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
Other adverse events
| Measure |
Cohort 1
n=2 participants at risk
Subjects received an initial loading dose of 111\^In-CS-1008 (0.2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 2
n=4 participants at risk
Subjects received an initial loading dose of 111\^In-CS-1008 (1 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 3
n=5 participants at risk
Subjects received an initial loading dose of 111\^In-CS-1008 (2 mg/kg) on Day 1, CS-1008 (6 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 4
n=3 participants at risk
Subjects received an initial loading dose of 111\^In-CS-1008 (4 mg/kg) on Day 1, CS-1008 (4 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
Cohort 5
n=5 participants at risk
Subjects received an initial loading dose of 111\^In-CS-1008 (6 mg/kg) on Day 1, CS-1008 (2 mg/kg) on Day 8, and subsequent weekly doses of CS-1008 (2 mg/kg) on Days 15, 22, 29, 36, and 43; the Day 36 dose was also radiolabeled with 111\^In. Additional 4-week cycles of weekly CS-1008 (2 mg/kg) were permitted for subjects benefiting from treatment.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Eye disorders
Diplopia
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Eye disorders
Lacrimation increased
|
50.0%
1/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
66.7%
2/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
40.0%
2/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
40.0%
2/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal distension
|
50.0%
1/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Fatigue
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Urinary tract infection
|
50.0%
1/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
66.7%
2/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Infection
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Skin candida
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Investigations
Gamma-glutamyltransferase increased
|
50.0%
1/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
2/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
1/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
50.0%
1/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
66.7%
2/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
25.0%
1/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
20.0%
1/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/4 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
33.3%
1/3 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
0.00%
0/5 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 7 months.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.0), relationship to study drug, seriousness, study drug intervention, treatment, and outcome. In summaries, preferred terms were counted only once per subject at the maximum reported grade.
|
Additional Information
Jonathan Skipper PhD
Ludwig Institute for Cancer Research
Phone: (212) 450-1539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place