Trial Outcomes & Findings for A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma (NCT NCT02594384)

NCT ID: NCT02594384

Last Updated: 2024-08-22

Results Overview

MTD was determined by testing increasing doses up to 125 mg twice a day or 75 mg three times a day orally on dose escalation cohorts with 3 to 6 participants each. In the dose escalation, the cohort sizes of 3 to 6 subjects allow evaluation of regimen safety using a standard definition of MTD (ie, the highest starting dose associated with DLT in \<33% of subjects during the first cycle of therapy) when administered continuously (daily administration) and then when administered intermittently (repeated courses of 3 days on and 4 days off).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

62 participants

Primary outcome timeframe

28 days

Results posted on

2024-08-22

Participant Flow

This study was conducted at 12 study centers in the United States, 11 of which enrolled subjects to the trial.

Participant milestones

Participant milestones
Measure
LAM-002A Continuous Monotherapy - 50 mg BID
All participants took 50 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 100 mg BID
All participants took 100 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 150 mg BID
All participants took 150 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 75 mg TID
All participants took 75 mg LAM-002A three times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Intermittent Monotherapy - 150 mg BID
All participants received LAM-002A at 150 mg two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 125 mg
All participants took 125 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A + Rituximab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab by vein (IV) every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions) or one dose of rituximab IV followed by rituximab subcutaneous (SC) for 3 weeks and then SC every 8 weeks for 4 times (total of 8 doses). Rituximab: 375 mg/m\^2 IV or rituximab (hyaluronidase) (1,400 mg rituximab and 23,400 Units hyaluronidase human) SC
LAM-002A + Atezolizumab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability Atezolizumab: 1200 mg by vein
Overall Study
STARTED
3
8
5
4
3
20
12
7
Overall Study
COMPLETED
0
0
0
0
0
1
3
0
Overall Study
NOT COMPLETED
3
8
5
4
3
19
9
7

Reasons for withdrawal

Reasons for withdrawal
Measure
LAM-002A Continuous Monotherapy - 50 mg BID
All participants took 50 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 100 mg BID
All participants took 100 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 150 mg BID
All participants took 150 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 75 mg TID
All participants took 75 mg LAM-002A three times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Intermittent Monotherapy - 150 mg BID
All participants received LAM-002A at 150 mg two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 125 mg
All participants took 125 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A + Rituximab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab by vein (IV) every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions) or one dose of rituximab IV followed by rituximab subcutaneous (SC) for 3 weeks and then SC every 8 weeks for 4 times (total of 8 doses). Rituximab: 375 mg/m\^2 IV or rituximab (hyaluronidase) (1,400 mg rituximab and 23,400 Units hyaluronidase human) SC
LAM-002A + Atezolizumab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability Atezolizumab: 1200 mg by vein
Overall Study
Disease Progression
3
7
0
2
2
12
5
5
Overall Study
Adverse Event
0
1
4
1
0
6
1
1
Overall Study
Withdrawal by Subject
0
0
0
1
0
0
0
1
Overall Study
Physician Decision
0
0
0
0
0
1
2
0
Overall Study
Progressive Leukocytosis
0
0
1
0
0
0
0
0
Overall Study
Lack of Efficacy
0
0
0
0
1
0
0
0
Overall Study
Substantial noncompliance
0
0
0
0
0
0
1
0

Baseline Characteristics

A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
LAM-002A Continuous Monotherapy - 50 mg BID
n=3 Participants
All participants took 50 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 100 mg BID
n=8 Participants
All participants took 100 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 150 mg BID
n=5 Participants
All participants took 150 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 75 mg TID
n=4 Participants
All participants took 75 mg LAM-002A three times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Intermittent Monotherapy - 150 mg BID
n=3 Participants
All participants received LAM-002A at 150 mg two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 125 mg
n=20 Participants
All participants took 125 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A + Rituximab
n=12 Participants
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab by vein (IV) every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions) or one dose of rituximab IV followed by rituximab subcutaneous (SC) for 3 weeks and then SC every 8 weeks for 4 times (total of 8 doses). Rituximab: 375 mg/m\^2 IV or rituximab (hyaluronidase) (1,400 mg rituximab and 23,400 Units hyaluronidase human) SC
LAM-002A + Atezolizumab
n=7 Participants
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability Atezolizumab: 1200 mg by vein
Total
n=62 Participants
Total of all reporting groups
Age, Customized
Age Category · <65 years
2 Participants
n=39 Participants
3 Participants
n=41 Participants
1 Participants
n=35 Participants
0 Participants
n=31 Participants
0 Participants
n=146 Participants
9 Participants
n=19 Participants
7 Participants
n=147 Participants
2 Participants
n=193 Participants
24 Participants
Age, Customized
Age Category · ≥65 years
1 Participants
n=39 Participants
5 Participants
n=41 Participants
4 Participants
n=35 Participants
4 Participants
n=31 Participants
3 Participants
n=146 Participants
11 Participants
n=19 Participants
5 Participants
n=147 Participants
5 Participants
n=193 Participants
38 Participants
Sex: Female, Male
Female
1 Participants
n=39 Participants
5 Participants
n=41 Participants
4 Participants
n=35 Participants
2 Participants
n=31 Participants
2 Participants
n=146 Participants
9 Participants
n=19 Participants
4 Participants
n=147 Participants
3 Participants
n=193 Participants
30 Participants
Sex: Female, Male
Male
2 Participants
n=39 Participants
3 Participants
n=41 Participants
1 Participants
n=35 Participants
2 Participants
n=31 Participants
1 Participants
n=146 Participants
11 Participants
n=19 Participants
8 Participants
n=147 Participants
4 Participants
n=193 Participants
32 Participants
Race/Ethnicity, Customized
Race · White
3 Participants
n=39 Participants
6 Participants
n=41 Participants
4 Participants
n=35 Participants
3 Participants
n=31 Participants
3 Participants
n=146 Participants
16 Participants
n=19 Participants
11 Participants
n=147 Participants
7 Participants
n=193 Participants
53 Participants
Race/Ethnicity, Customized
Race · Black/African American
0 Participants
n=39 Participants
1 Participants
n=41 Participants
0 Participants
n=35 Participants
1 Participants
n=31 Participants
0 Participants
n=146 Participants
1 Participants
n=19 Participants
1 Participants
n=147 Participants
0 Participants
n=193 Participants
4 Participants
Race/Ethnicity, Customized
Race · Other
0 Participants
n=39 Participants
1 Participants
n=41 Participants
1 Participants
n=35 Participants
0 Participants
n=31 Participants
0 Participants
n=146 Participants
3 Participants
n=19 Participants
0 Participants
n=147 Participants
0 Participants
n=193 Participants
5 Participants
Race/Ethnicity, Customized
Ethnicity · Not Hispanic/Latino
3 Participants
n=39 Participants
8 Participants
n=41 Participants
5 Participants
n=35 Participants
3 Participants
n=31 Participants
3 Participants
n=146 Participants
16 Participants
n=19 Participants
12 Participants
n=147 Participants
7 Participants
n=193 Participants
57 Participants
Race/Ethnicity, Customized
Ethnicity · Hispanic/Latino
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
1 Participants
n=31 Participants
0 Participants
n=146 Participants
4 Participants
n=19 Participants
0 Participants
n=147 Participants
0 Participants
n=193 Participants
5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status
0, fully active, able to carry on all predisease performance without restrictions
0 Participants
n=39 Participants
5 Participants
n=41 Participants
1 Participants
n=35 Participants
1 Participants
n=31 Participants
1 Participants
n=146 Participants
7 Participants
n=19 Participants
3 Participants
n=147 Participants
0 Participants
n=193 Participants
18 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status
1, restricted in physically strenuous activity but ambulatory and able to do light or sedentary work
3 Participants
n=39 Participants
3 Participants
n=41 Participants
3 Participants
n=35 Participants
2 Participants
n=31 Participants
2 Participants
n=146 Participants
11 Participants
n=19 Participants
9 Participants
n=147 Participants
6 Participants
n=193 Participants
39 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status
2, ambulatory and capable of all self-care but unable to work. Up more than 50% of waking hours
0 Participants
n=39 Participants
0 Participants
n=41 Participants
1 Participants
n=35 Participants
1 Participants
n=31 Participants
0 Participants
n=146 Participants
2 Participants
n=19 Participants
0 Participants
n=147 Participants
0 Participants
n=193 Participants
4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status
3, capable of only limited self-care, confined to bed or chair more than 50% of waking hours
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
0 Participants
n=31 Participants
0 Participants
n=146 Participants
0 Participants
n=19 Participants
0 Participants
n=147 Participants
1 Participants
n=193 Participants
1 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Full analysis set=All subjects who receive ≥1 dose of study drug.

MTD was determined by testing increasing doses up to 125 mg twice a day or 75 mg three times a day orally on dose escalation cohorts with 3 to 6 participants each. In the dose escalation, the cohort sizes of 3 to 6 subjects allow evaluation of regimen safety using a standard definition of MTD (ie, the highest starting dose associated with DLT in \<33% of subjects during the first cycle of therapy) when administered continuously (daily administration) and then when administered intermittently (repeated courses of 3 days on and 4 days off).

Outcome measures

Outcome measures
Measure
All Participants
n=40 Participants
All participants who received at least 1 dose of LAM-002A, either at 50 mg BID, 100 mg BID, 150 mg BID, 75 mg TID, or 125 mg BID.
LAM-002A Continuous Monotherapy - 75 mg TID
All participants took 75 mg LAM-002A three times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 100 mg BID
All participants took 100 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 125 mg BID
All participants took 125 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 150 mg BID
All participants took 150 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Intermittent Monotherapy - 150 mg
All participants received LAM-002A at 150 mg two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A + Rituximab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab by vein (IV) every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions) or one dose of rituximab IV followed by rituximab subcutaneous (SC) for 3 weeks and then SC every 8 weeks for 4 times (total of 8 doses). Rituximab: 375 mg/m\^2 IV or rituximab (hyaluronidase) (1,400 mg rituximab and 23,400 Units hyaluronidase human) SC
LAM-002A + Atezolizumab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability Atezolizumab: 1200 mg by vein
Determination of the Maximum Tolerated Dose (MTD) of Continuous Oral LAM-002A
125 mg BID

SECONDARY outcome

Timeframe: 8 days

Population: The PK population included all evaluable subjects who were dosed and had sufficient concentration-time data to estimate ≥1 of the planned PK parameters, as determined by the study pharmacokineticist.

Evaluation of the peak plasma concentration (Cmax) of LAM-002A and its metabolites in plasma on Day 1 and Day 8.

Outcome measures

Outcome measures
Measure
All Participants
n=3 Participants
All participants who received at least 1 dose of LAM-002A, either at 50 mg BID, 100 mg BID, 150 mg BID, 75 mg TID, or 125 mg BID.
LAM-002A Continuous Monotherapy - 75 mg TID
n=3 Participants
All participants took 75 mg LAM-002A three times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 100 mg BID
n=8 Participants
All participants took 100 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 125 mg BID
n=6 Participants
All participants took 125 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 150 mg BID
n=5 Participants
All participants took 150 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Intermittent Monotherapy - 150 mg
n=3 Participants
All participants received LAM-002A at 150 mg two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A + Rituximab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab by vein (IV) every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions) or one dose of rituximab IV followed by rituximab subcutaneous (SC) for 3 weeks and then SC every 8 weeks for 4 times (total of 8 doses). Rituximab: 375 mg/m\^2 IV or rituximab (hyaluronidase) (1,400 mg rituximab and 23,400 Units hyaluronidase human) SC
LAM-002A + Atezolizumab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability Atezolizumab: 1200 mg by vein
Peak Plasma Concentration (Cmax) of LAM-002A
STA-6048 - Day 8
60.6 ng/mL
Standard Deviation 32.0
154 ng/mL
Standard Deviation 113
161 ng/mL
Standard Deviation 43.0
122 ng/mL
Standard Deviation 81.7
116 ng/mL
Standard Deviation 87.4
140 ng/mL
Peak Plasma Concentration (Cmax) of LAM-002A
Apilimod - Day 1
117 ng/mL
Standard Deviation 69.6
158 ng/mL
Standard Deviation 61.6
263 ng/mL
Standard Deviation 168
207 ng/mL
Standard Deviation 82.4
243 ng/mL
Standard Deviation 76.1
280 ng/mL
Standard Deviation 135
Peak Plasma Concentration (Cmax) of LAM-002A
Apilimod - Day 8
140 ng/mL
Standard Deviation 95.1
339 ng/mL
Standard Deviation 215
331 ng/mL
Standard Deviation 273
331 ng/mL
Standard Deviation 287
369 ng/mL
Standard Deviation 90.5
108 ng/mL
Peak Plasma Concentration (Cmax) of LAM-002A
STA-5908 - Day 1
112 ng/mL
Standard Deviation 85.0
114 ng/mL
Standard Deviation 71.6
215 ng/mL
Standard Deviation 88.6
144 ng/mL
Standard Deviation 92.5
196 ng/mL
Standard Deviation 142
207 ng/mL
Standard Deviation 135
Peak Plasma Concentration (Cmax) of LAM-002A
STA-5908 - Day 8
103 ng/mL
Standard Deviation 43.7
239 ng/mL
Standard Deviation 195
278 ng/mL
Standard Deviation 137
234 ng/mL
Standard Deviation 173
240 ng/mL
Standard Deviation 99.7
113 ng/mL
Peak Plasma Concentration (Cmax) of LAM-002A
STA-5944 - Day 1
209 ng/mL
Standard Deviation 145
243 ng/mL
Standard Deviation 124
346 ng/mL
Standard Deviation 131
281 ng/mL
Standard Deviation 125
369 ng/mL
Standard Deviation 306
466 ng/mL
Standard Deviation 247
Peak Plasma Concentration (Cmax) of LAM-002A
STA-5944 - Day 8
188 ng/mL
Standard Deviation 101
436 ng/mL
Standard Deviation 334
439 ng/mL
Standard Deviation 215
383 ng/mL
Standard Deviation 225
391 ng/mL
Standard Deviation 9.90
260 ng/mL
Peak Plasma Concentration (Cmax) of LAM-002A
STA-6048 - Day 1
63.2 ng/mL
Standard Deviation 40.2
59.9 ng/mL
Standard Deviation 54.0
136 ng/mL
Standard Deviation 64.2
90.0 ng/mL
Standard Deviation 58.6
131 ng/mL
Standard Deviation 134
145 ng/mL
Standard Deviation 66.0

SECONDARY outcome

Timeframe: 8 days

Population: The PK population included all evaluable subjects who were dosed and had sufficient concentration-time data to estimate ≥1 of the planned PK parameters, as determined by the study pharmacokineticist.

Evaluation of the Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration (AUClast) of LAM-002ALAM-002A and its metabolites in plasma on Day 1 and Day 8.

Outcome measures

Outcome measures
Measure
All Participants
n=3 Participants
All participants who received at least 1 dose of LAM-002A, either at 50 mg BID, 100 mg BID, 150 mg BID, 75 mg TID, or 125 mg BID.
LAM-002A Continuous Monotherapy - 75 mg TID
n=3 Participants
All participants took 75 mg LAM-002A three times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 100 mg BID
n=8 Participants
All participants took 100 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 125 mg BID
n=6 Participants
All participants took 125 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 150 mg BID
n=5 Participants
All participants took 150 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Intermittent Monotherapy - 150 mg
n=3 Participants
All participants received LAM-002A at 150 mg two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A + Rituximab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab by vein (IV) every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions) or one dose of rituximab IV followed by rituximab subcutaneous (SC) for 3 weeks and then SC every 8 weeks for 4 times (total of 8 doses). Rituximab: 375 mg/m\^2 IV or rituximab (hyaluronidase) (1,400 mg rituximab and 23,400 Units hyaluronidase human) SC
LAM-002A + Atezolizumab
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability Atezolizumab: 1200 mg by vein
Area Under the Plasma Concentration Versus Time Curve (AUC) of LAM-002A
Apilimod - Day 1
238 h*ng/mL
Standard Deviation 88.1
583 h*ng/mL
Standard Deviation 290
515 h*ng/mL
Standard Deviation 221
562 h*ng/mL
Standard Deviation 234
700 h*ng/mL
Standard Deviation 290
777 h*ng/mL
Standard Deviation 437
Area Under the Plasma Concentration Versus Time Curve (AUC) of LAM-002A
Apilimod - Day 8
374 h*ng/mL
Standard Deviation 119
1040 h*ng/mL
Standard Deviation 483
1130 h*ng/mL
Standard Deviation 930
1290 h*ng/mL
Standard Deviation 1040
1060 h*ng/mL
Standard Deviation 85.7
563 h*ng/mL
Area Under the Plasma Concentration Versus Time Curve (AUC) of LAM-002A
STA-5944 - Day 1
542 h*ng/mL
Standard Deviation 214
1020 h*ng/mL
Standard Deviation 659
1120 h*ng/mL
Standard Deviation 550
1180 h*ng/mL
Standard Deviation 587
1590 h*ng/mL
Standard Deviation 1420
1700 h*ng/mL
Standard Deviation 843
Area Under the Plasma Concentration Versus Time Curve (AUC) of LAM-002A
STA-5908 - Day 1
312 h*ng/mL
Standard Deviation 156
526 h*ng/mL
Standard Deviation 291
762 h*ng/mL
Standard Deviation 371
625 h*ng/mL
Standard Deviation 419
936 h*ng/mL
Standard Deviation 734
968 h*ng/mL
Standard Deviation 547
Area Under the Plasma Concentration Versus Time Curve (AUC) of LAM-002A
STA-6048 - Day 8
308 h*ng/mL
Standard Deviation 164
1040 h*ng/mL
Standard Deviation 780
959 h*ng/mL
Standard Deviation 343
746 h*ng/mL
Standard Deviation 509
556 h*ng/mL
Standard Deviation 397
760 h*ng/mL
Area Under the Plasma Concentration Versus Time Curve (AUC) of LAM-002A
STA-5944 - Day 8
653 h*ng/mL
Standard Deviation 365
2070 h*ng/mL
Standard Deviation 1430
1810 h*ng/mL
Standard Deviation 1240
1860 h*ng/mL
Standard Deviation 1160
1320 h*ng/mL
Standard Deviation 211
1350 h*ng/mL
Area Under the Plasma Concentration Versus Time Curve (AUC) of LAM-002A
STA-5908 - Day 8
433 h*ng/mL
Standard Deviation 195
1140 h*ng/mL
Standard Deviation 818
1360 h*ng/mL
Standard Deviation 796
1270 h*ng/mL
Standard Deviation 875
1040 h*ng/mL
Standard Deviation 572
690 h*ng/mL
Area Under the Plasma Concentration Versus Time Curve (AUC) of LAM-002A
STA-6048 - Day 1
238 h*ng/mL
Standard Deviation 91.2
280 h*ng/mL
Standard Deviation 216
622 h*ng/mL
Standard Deviation 372
443 h*ng/mL
Standard Deviation 325
785 h*ng/mL
Standard Deviation 923
869 h*ng/mL
Standard Deviation 415

SECONDARY outcome

Timeframe: 1 cycle (28 days) up to a maximum of 24 cycles

Population: Full Analysis Set: All participants who received ≥1 dose of study drug.

Anti-tumor response as assessed by investigator according to modified Hallek or Lugano Response Criteria by Disease Type and Cohort

Outcome measures

Outcome measures
Measure
All Participants
n=3 Participants
All participants who received at least 1 dose of LAM-002A, either at 50 mg BID, 100 mg BID, 150 mg BID, 75 mg TID, or 125 mg BID.
LAM-002A Continuous Monotherapy - 75 mg TID
n=8 Participants
All participants took 75 mg LAM-002A three times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 100 mg BID
n=5 Participants
All participants took 100 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 125 mg BID
n=4 Participants
All participants took 125 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 150 mg BID
n=3 Participants
All participants took 150 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Intermittent Monotherapy - 150 mg
n=20 Participants
All participants received LAM-002A at 150 mg two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A + Rituximab
n=12 Participants
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab by vein (IV) every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions) or one dose of rituximab IV followed by rituximab subcutaneous (SC) for 3 weeks and then SC every 8 weeks for 4 times (total of 8 doses). Rituximab: 375 mg/m\^2 IV or rituximab (hyaluronidase) (1,400 mg rituximab and 23,400 Units hyaluronidase human) SC
LAM-002A + Atezolizumab
n=7 Participants
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability Atezolizumab: 1200 mg by vein
Objective Response Rate
FL (follicular lymphoma)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants
5 Participants
2 Participants
Objective Response Rate
MZL (marginal zone lymphoma)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Objective Response Rate
MCL (mantle cell lymphoma)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Objective Response Rate
CLL/SLL (chronic lymphocytic leukemia/ small lymphocytic lymphoma)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Objective Response Rate
DLBCL (diffuse large B-cell lymphoma)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

Adverse Events

LAM-002A Continuous Monotherapy - 50 mg BID

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

LAM-002A Continuous Monotherapy - 100 mg BID

Serious events: 3 serious events
Other events: 8 other events
Deaths: 1 deaths

LAM-002A Continuous Monotherapy - 150 mg BID

Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths

LAM-002A Continuous Monotherapy - 75 mg TID

Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths

LAM-002A Intermittent Monotherapy - 150 mg BID

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

LAM-002A Continuous Monotherapy - 125 mg BID

Serious events: 9 serious events
Other events: 20 other events
Deaths: 3 deaths

LAM-002A + Rituximab

Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths

LAM-002A + Atezolizumab

Serious events: 6 serious events
Other events: 7 other events
Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure
LAM-002A Continuous Monotherapy - 50 mg BID
n=3 participants at risk
All participants took 50 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 100 mg BID
n=8 participants at risk
All participants took 100 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 150 mg BID
n=5 participants at risk
All participants took 150 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 75 mg TID
n=4 participants at risk
All participants took 75 mg LAM-002A three times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Intermittent Monotherapy - 150 mg BID
n=3 participants at risk
All participants received LAM-002A at 150 mg two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 125 mg BID
n=20 participants at risk
All participants took 125 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A + Rituximab
n=12 participants at risk
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab by vein (IV) every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions) or one dose of rituximab IV followed by rituximab subcutaneous (SC) for 3 weeks and then SC every 8 weeks for 4 times (total of 8 doses). Rituximab: 375 mg/m\^2 IV or rituximab (hyaluronidase) (1,400 mg rituximab and 23,400 Units hyaluronidase human) SC
LAM-002A + Atezolizumab
n=7 participants at risk
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability Atezolizumab: 1200 mg by vein
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Number of events 2 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Pancreatitis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Colitis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Nausea
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Disease progression
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Fatigue
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Lung infection
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Pneumocystis jirovecii pneumonia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Haemorrhage intracranial
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Syncope
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Renal and urinary disorders
Acute kidney injury
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Number of events 2 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Number of events 2 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Vascular disorders
Hypotension
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Vascular disorders
Orthostatic hypotension
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications
Fall
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Neutrophil count decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Platelet count decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Dehydration
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Compartment syndrome
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Pneumonia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Gastroenteritis viral
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Tumour lysis syndrome
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
16.7%
2/12 • Number of events 2 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Lethargy
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood sodium decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Psychiatric disorders
Confusional state
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Number of events 1 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.

Other adverse events

Other adverse events
Measure
LAM-002A Continuous Monotherapy - 50 mg BID
n=3 participants at risk
All participants took 50 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 100 mg BID
n=8 participants at risk
All participants took 100 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 150 mg BID
n=5 participants at risk
All participants took 150 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 75 mg TID
n=4 participants at risk
All participants took 75 mg LAM-002A three times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Intermittent Monotherapy - 150 mg BID
n=3 participants at risk
All participants received LAM-002A at 150 mg two times daily by mouth for 3 days on therapy followed by 4 days off therapy every week until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A Continuous Monotherapy - 125 mg BID
n=20 participants at risk
All participants took 125 mg LAM-002A two times daily by mouth every day until cancer progression or intolerability. LAM-002A: 25 mg capsules or 50 mg capsules
LAM-002A + Rituximab
n=12 participants at risk
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and rituximab by vein (IV) every week for 4 weeks and then every 8 weeks for 4 times (total of 8 infusions) or one dose of rituximab IV followed by rituximab subcutaneous (SC) for 3 weeks and then SC every 8 weeks for 4 times (total of 8 doses). Rituximab: 375 mg/m\^2 IV or rituximab (hyaluronidase) (1,400 mg rituximab and 23,400 Units hyaluronidase human) SC
LAM-002A + Atezolizumab
n=7 participants at risk
All participants received LAM-002A 125mg two times daily by mouth every day until cancer progression or intolerability and atezolizumab 1200 mg by vein every 3 weeks until cancer progression or intolerability Atezolizumab: 1200 mg by vein
Gastrointestinal disorders
Nausea
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
37.5%
3/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
60.0%
3/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
75.0%
3/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
45.0%
9/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
50.0%
6/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
85.7%
6/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Diarrhoea
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
40.0%
2/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
50.0%
2/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
66.7%
2/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
30.0%
6/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
50.0%
6/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Vomiting
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
60.0%
3/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
75.0%
3/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
4/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
3/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
57.1%
4/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Constipation
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
2/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
50.0%
2/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
15.0%
3/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
71.4%
5/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Abdominal pain
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
5/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Dry mouth
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Abdominal distension
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
28.6%
2/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Anal incontinence
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Dental caries
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Ascites
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
28.6%
2/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Dysphagia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Colitis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Dyspepsia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Eructation
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Flatulence
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Hyperchlorhydria
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Large intestine polyp
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Pancreatitis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Paraesthesia oral
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Proctalgia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Retching
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Sensitivity of teeth
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Stomatitis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Toothache
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders
Tooth disorder
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Fatigue
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
50.0%
4/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
40.0%
2/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
50.0%
2/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
50.0%
10/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
58.3%
7/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Asthenia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
5/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Oedema peripheral
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
50.0%
2/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
15.0%
3/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
16.7%
2/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Chills
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
2/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
16.7%
2/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Disease progression
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Gait disturbance
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Eye complication associated with device
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Adverse drug reaction
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Chest pain
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Face oedema
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Injection site bruising
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Multiple organ dysfunction syndrome
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Oedema
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Pain
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Peripheral swelling
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Pyrexia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
42.9%
3/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Influenza like illness
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
General disorders
Non-cardiac chest pain
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Hemoglobin decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
37.5%
3/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
50.0%
2/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
5/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood sodium decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
2/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
40.0%
2/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
4/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Platelet count decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
37.5%
3/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
15.0%
3/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
16.7%
2/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Neutrophil count decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
2/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
15.0%
3/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
16.7%
2/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
28.6%
2/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood creatinine increased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
50.0%
2/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Aspartate aminotransferase increased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
15.0%
3/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood bilirubin increased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
50.0%
2/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
16.7%
2/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood potassium decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
40.0%
2/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
16.7%
2/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Electrocardiogram QT prolonged
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
60.0%
3/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Lymphocyte count decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
15.0%
3/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
16.7%
2/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Weight decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
50.0%
2/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Alanine aminotransferase increased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood alkaline phosphatase increased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood glucose increased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
White blood cell count decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood albumin decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood calcium decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood glucose decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood phosphorus increased
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood uric acid increased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
40.0%
2/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
16.7%
2/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Ammonia increased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood cholesterol increased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Weight increased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood lactic acid increased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood magnesium decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood potassium increased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood sodium increased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Cardiac murmur
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Bacteraemia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
White blood cell count increased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood calcium increased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Investigations
Blood phosphorus decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Dysgeusia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
2/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
4/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Headache
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
40.0%
2/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
3/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Neuropathy peripheral
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Dizziness
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
3/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
42.9%
3/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Hypoaesthesia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Restless legs syndrome
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Seizure
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Dysarthria
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Haemorrhage intracranial
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Metabolic encephalopathy
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Syncope
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Paraesthesia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Somnolence
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Ageusia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Asterixis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Ataxia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Hepatic encephalopathy
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Hyperaesthesia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Lethargy
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Nervous system disorders
Spinal cord compression
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Urinary tract infection
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
15.0%
3/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Oral candidiasis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Candida infection
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Herpes zoster
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Pneumonia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
16.7%
2/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
28.6%
2/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Tooth abscess
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
2/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Bronchitis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Cellulitis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Fungal skin infection
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Lung infection
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Oesophageal candidiasis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Pneumocystis jirovecii pneumonia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Salmonellosis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Sepsis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Sinusitis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Upper respiratory tract infection
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
3/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Conjunctivitis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Eye infection
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Gastroenteritis viral
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Infections and infestations
Vulvovaginitis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
2/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
4/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
28.6%
2/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
15.0%
3/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Pain in jaw
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
3/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Compartment syndrome
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Groin pain
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders
Joint swelling
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
40.0%
8/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
3/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Dehydration
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
4/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
16.7%
2/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
28.6%
2/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Glucose tolerance impaired
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Metabolic acidosis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Tumour lysis syndrome
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
16.7%
2/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Iron deficiency
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Malnutrition
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Metabolism and nutrition disorders
Vitamin K deficiency
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
50.0%
2/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
16.7%
2/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
15.0%
3/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
4/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
28.6%
2/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Lung infiltration
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Tachypnoea
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Sinus pain
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Psychiatric disorders
Insomnia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
40.0%
2/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
66.7%
2/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
28.6%
2/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Psychiatric disorders
Anxiety
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
28.6%
2/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Psychiatric disorders
Depression
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Psychiatric disorders
Mental status changes
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Psychiatric disorders
Agitation
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Psychiatric disorders
Confusional state
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
16.7%
2/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Vascular disorders
Hypotension
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Vascular disorders
Orthostatic hypotension
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Vascular disorders
Deep vein thrombosis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Vascular disorders
Hot flush
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Vascular disorders
Hypertension
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Vascular disorders
Hypovolaemic shock
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Renal and urinary disorders
Acute kidney injury
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
4/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Renal and urinary disorders
Haematuria
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Renal and urinary disorders
Pollakiuria
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
3/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Renal and urinary disorders
Micturition urgency
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Renal and urinary disorders
Urinary incontinence
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
10.0%
2/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Rash maculo-papular
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders
Drug eruption
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Blood and lymphatic system disorders
Disseminated intravascular coagulation
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Cardiac disorders
Atrial fibrillation
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Cardiac disorders
Cardiac arrest
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Cardiac disorders
Left ventricular dysfunction
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Cardiac disorders
Sinus tachycardia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Cardiac disorders
Supraventricular tachycardia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Cardiac disorders
Right ventricular enlargement
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Cardiac disorders
Sinus arrhythmia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Cardiac disorders
Sinus bradycardia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Cardiac disorders
Tachycardia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications
Fall
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications
Spinal fracture
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
3/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications
Wound
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications
Femur fracture
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Injury, poisoning and procedural complications
Wound secretion
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Eye disorders
Cataract
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
20.0%
1/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Eye disorders
Eye pain
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Eye disorders
Vision blurred
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Eye disorders
Diplopia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Eye disorders
Eyelid ptosis
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
14.3%
1/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Ear and labyrinth disorders
Ear discomfort
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Ear and labyrinth disorders
Tinnitus
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Ear and labyrinth disorders
Vertigo
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Endocrine disorders
Hypercalcaemia of malignancy
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Endocrine disorders
Hypothyroidism
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Hepatobiliary disorders
Jaundice cholestatic
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
5.0%
1/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Immune system disorders
Hypogammaglobulinaemia
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
12.5%
1/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Immune system disorders
Drug hypersensitivity
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
33.3%
1/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Immune system disorders
Hypersensitivity
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
Surgical and medical procedures
Sinus operation
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/8 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/5 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
25.0%
1/4 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/3 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/20 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
8.3%
1/12 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.
0.00%
0/7 • Adverse Events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0. AEs, including SAEs, were captured from Cycle 1 Day 1 through 30 days after the last dose of study treatment, an average of 4.5 months.
Adverse Events were analyzed for all participants who received at least 1 dose of study treatment.

Additional Information

Esther Nkrumah

OrphAI Therapeutics

Phone: 267 512-1750

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place