Trial Outcomes & Findings for Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL (NCT NCT01897571)
NCT ID: NCT01897571
Last Updated: 2024-03-26
Results Overview
Recommended Phase 2 dose (RP2D) of tazemetostat as administered orally twice daily (BID), continuously in 28-day cycles in subjects with advanced solid tumors or with relapsed and/or refractory B cell lymphomas as determined by incidence, seriousness, toxicity grade, and relatedness of treatment emergent dose limiting toxicities
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
400 participants
Primary outcome timeframe
The first 28-day cycle of therapy
Results posted on
2024-03-26
Participant Flow
Participant milestones
| Measure |
Phase 1: Tazemetostat 100 mg
Patients received tazemetostat 100 milligrams (mg) tablets orally twice daily (BID) in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 200 mg
Patients received tazemetostat 200 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 400 mg
Patients received tazemetostat 400 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 800 mg
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 1600 mg
Patients received tazemetostat 1600 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Food Effect (All Patients)
Patients received tazemetostat 200 mg as a single oral dose on Day -8 either after fasting for 8 hours before dosing or immediately after consuming a high-fat breakfast on Day -8. Following a 7-day washout period, patients crossed over to receive the second tazemetostat 200 mg single oral dose on Day -1 in the opposite condition (fed or fasted).
|
Phase 1: Tazemetostat 800 mg + Midazolam 2 mg
Patients received tazemetostat 800 mg orally BID continuously starting on Day 1, with a single oral dose of midazolam 2 mg administered on Day -1 and then on Day 15. Post Day 15, patients continued to receive tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 1: Tazemetostat in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) With Mutant EZH2
Patients with R/R FL with mutant enhancer of zeste homolog 2 (EZH2) treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2
Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 3: Tazemetostat in R/R Diffuse Large B-cell Lymphoma (DLBCL) Monotherapy
Patients with R/R DLBCL received 800 mg of tazemetostat monotherapy, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. In addition, these patients also received prednisolone 40 mg/meter square (m\^2) on Days 1 to 5 and 15 to 19 from Cycle 1 to Cycle 4 post which tazemetostat monotherapy was continued.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
3
|
14
|
12
|
13
|
13
|
48
|
54
|
163
|
71
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
5
|
0
|
0
|
1
|
16
|
19
|
20
|
6
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
3
|
9
|
12
|
13
|
12
|
32
|
35
|
143
|
65
|
Reasons for withdrawal
| Measure |
Phase 1: Tazemetostat 100 mg
Patients received tazemetostat 100 milligrams (mg) tablets orally twice daily (BID) in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 200 mg
Patients received tazemetostat 200 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 400 mg
Patients received tazemetostat 400 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 800 mg
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 1600 mg
Patients received tazemetostat 1600 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Food Effect (All Patients)
Patients received tazemetostat 200 mg as a single oral dose on Day -8 either after fasting for 8 hours before dosing or immediately after consuming a high-fat breakfast on Day -8. Following a 7-day washout period, patients crossed over to receive the second tazemetostat 200 mg single oral dose on Day -1 in the opposite condition (fed or fasted).
|
Phase 1: Tazemetostat 800 mg + Midazolam 2 mg
Patients received tazemetostat 800 mg orally BID continuously starting on Day 1, with a single oral dose of midazolam 2 mg administered on Day -1 and then on Day 15. Post Day 15, patients continued to receive tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 1: Tazemetostat in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) With Mutant EZH2
Patients with R/R FL with mutant enhancer of zeste homolog 2 (EZH2) treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2
Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 3: Tazemetostat in R/R Diffuse Large B-cell Lymphoma (DLBCL) Monotherapy
Patients with R/R DLBCL received 800 mg of tazemetostat monotherapy, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. In addition, these patients also received prednisolone 40 mg/meter square (m\^2) on Days 1 to 5 and 15 to 19 from Cycle 1 to Cycle 4 post which tazemetostat monotherapy was continued.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
1
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
3
|
1
|
|
Overall Study
Other
|
1
|
0
|
0
|
3
|
3
|
4
|
7
|
0
|
0
|
0
|
0
|
|
Overall Study
Enrolled in rollover study
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
7
|
9
|
1
|
|
Overall Study
Death
|
2
|
2
|
3
|
6
|
7
|
9
|
5
|
22
|
23
|
129
|
59
|
Baseline Characteristics
Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL
Baseline characteristics by cohort
| Measure |
Phase 1: Tazemetostat 100 mg
n=6 Participants
Patients received tazemetostat 100 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 200 mg
n=3 Participants
Patients received tazemetostat 200 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent
|
Phase 1: Tazemetostat 400 mg
n=3 Participants
Patients received tazemetostat 400 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 800 mg
n=14 Participants
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent
|
Phase 1: Tazemetostat 1600 mg
n=12 Participants
Patients received tazemetostat 1600 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Food Effect (All Patients)
n=13 Participants
Patients received tazemetostat 200 mg as a single oral dose on Day -8 either after fasting for 8 hours before dosing or immediately after consuming a high-fat breakfast on Day -8. Following a 7-day washout period, patients crossed over to receive the second tazemetostat 200 mg single oral dose on Day -1 in the opposite condition (fed or fasted).
|
Phase 1: Tazemetostat 800 mg + Midazolam 2 mg
n=13 Participants
Patients received tazemetostat 800 mg orally BID continuously starting on Day 1, with a single oral dose of midazolam 2 mg administered on Day -1 and then on Day 15. Post Day 15, patients continued to receive tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH2
n=48 Participants
Patients with R/R FL with mutant EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
Tazemetostat: Patients who received 800 mg of tazemetostat, BID, administered in continuous 28-day cycles.
|
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2
n=54 Participants
Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
Tazemetostat: Patients who received 800 mg of tazemetostat, BID, administered in continuous 28-day cycles.
|
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy
n=163 Participants
Patients with R/R DLBCL received 800 mg of tazemetostat monotherapy, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
Tazemetostat: Patients who received 800 mg of tazemetostat, BID, administered in continuous 28-day cycles.
|
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy
n=71 Participants
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. In addition, these patients also received prednisolone 40 mg/m\^2 on Days 1 to 5 and 15 to 19 from Cycle 1 to Cycle 4 post which tazemetostat monotherapy was continued.
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 15.74 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 30.20 • n=7 Participants
|
59.0 years
STANDARD_DEVIATION 7.00 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 13.54 • n=4 Participants
|
51.6 years
STANDARD_DEVIATION 21.42 • n=21 Participants
|
53.2 years
STANDARD_DEVIATION 16.39 • n=10 Participants
|
55.0 years
STANDARD_DEVIATION 13.66 • n=115 Participants
|
62.0 years
STANDARD_DEVIATION 8.83 • n=24 Participants
|
61.1 years
STANDARD_DEVIATION 11.38 • n=42 Participants
|
63.2 years
STANDARD_DEVIATION 14.35 • n=42 Participants
|
65.4 years
STANDARD_DEVIATION 11.78 • n=42 Participants
|
61.7 years
STANDARD_DEVIATION 13.7 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
26 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
72 Participants
n=42 Participants
|
32 Participants
n=42 Participants
|
176 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
22 Participants
n=24 Participants
|
34 Participants
n=42 Participants
|
91 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
224 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
38 Participants
n=24 Participants
|
26 Participants
n=42 Participants
|
103 Participants
n=42 Participants
|
62 Participants
n=42 Participants
|
268 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
57 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
125 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
33 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
71 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
186 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
15 Participants
n=24 Participants
|
38 Participants
n=42 Participants
|
89 Participants
n=42 Participants
|
41 Participants
n=42 Participants
|
208 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: The first 28-day cycle of therapyRecommended Phase 2 dose (RP2D) of tazemetostat as administered orally twice daily (BID), continuously in 28-day cycles in subjects with advanced solid tumors or with relapsed and/or refractory B cell lymphomas as determined by incidence, seriousness, toxicity grade, and relatedness of treatment emergent dose limiting toxicities
Outcome measures
| Measure |
Phase 1
n=64 Participants
Patients in the Phase 1 portion of the study. Tazemetostat: Patients who received 100 mg to 1600 mg of tazemetostat, BID, administered in continuous 28-day cycles.
|
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2
Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy
Patients with R/R DLBCL received 800 mg of tazemetostat monotherapy, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. In addition, these patients also received prednisolone 40 mg/m\^2 on Days 1 to 5 and 15 to 19 from Cycle 1 to Cycle 4 post which tazemetostat monotherapy was continued.
|
|---|---|---|---|---|
|
Recommended Phase 2 Dose (RP2D) of Tazemetostat as a Single-Agent and in Combination With Prednisolone (Phase 1 Only)
|
800 mg BID
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 8 weeks during Cycles 2 to 6,and then every 12 weeks thereafter until confirmed disease progression (PD)/death,a maximum of approximately 82 monthsNumber of patients achieving an objective response (CR or PR)/number of patients treated x 100%. ORR was calculated as the percentage of patients with a confirmed complete response (CR) or partial response (PR) relative to the total number of patients in the analysis population per response evaluation criteria in solid tumors (RECIST) version (v)1.1. Complete Response (CR) was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Outcome measures
| Measure |
Phase 1
n=48 Participants
Patients in the Phase 1 portion of the study. Tazemetostat: Patients who received 100 mg to 1600 mg of tazemetostat, BID, administered in continuous 28-day cycles.
|
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2
n=54 Participants
Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy
n=163 Participants
Patients with R/R DLBCL received 800 mg of tazemetostat monotherapy, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy
n=71 Participants
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. In addition, these patients also received prednisolone 40 mg/m\^2 on Days 1 to 5 and 15 to 19 from Cycle 1 to Cycle 4 post which tazemetostat monotherapy was continued.
|
|---|---|---|---|---|
|
Objective Response Rate (ORR; Complete Response + Partial Response [CR + PR]) (Phase 2)
|
34 Participants
|
19 Participants
|
30 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Radiologic tumor assessments performed at baseline (within 28 days before start of study treatment) and every 8 weeks during Cycles 2 to 6, and then every 12 weeks thereafter until confirmed PD/death, a maximum of approximately 82 monthsPopulation: Patients who had a complete or partial response per an Independent Review Committee. Note: the DOR for some patients was censored, meaning data collection was stopped early for analysis making the top limit of the 95% confidence interval not estimable.
The time (in months) from the date of the initial response (CR or PR, whichever was first) until the date of the first documented disease progression per an Independent Review Committee (for Groups 1 and 2), per Investigator (Group 3), or death due to any cause. Patients who were alive and progression free at the time of the analysis were censored at the last date where the patient was known to be in response. Note: the DOR was censored, meaning data collection was stopped early for analysis, making the top limit of the 95% confidence interval not estimable (NE). Per RECIST v.1.0, CR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Outcome measures
| Measure |
Phase 1
n=34 Participants
Patients in the Phase 1 portion of the study. Tazemetostat: Patients who received 100 mg to 1600 mg of tazemetostat, BID, administered in continuous 28-day cycles.
|
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2
n=19 Participants
Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy
n=163 Participants
Patients with R/R DLBCL received 800 mg of tazemetostat monotherapy, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy
n=71 Participants
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. In addition, these patients also received prednisolone 40 mg/m\^2 on Days 1 to 5 and 15 to 19 from Cycle 1 to Cycle 4 post which tazemetostat monotherapy was continued.
|
|---|---|---|---|---|
|
Duration of Response for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)
|
11.3 months
Interval 7.2 to
NA indicates that upper limit of confidence interval (CI) was not estimable due to insufficient number of participants with events at study closure.
|
13.0 months
Interval 5.6 to
NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.
|
5.8 months
Interval 3.7 to 12.8
|
5.7 months
Interval 2.1 to
NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at study closure.
|
SECONDARY outcome
Timeframe: Radiologic tumor assessments performed at baseline (within 28 days before start of study treatment) and every 8 weeks during Cycles 2 to 6, and then every 12 weeks thereafter until confirmed PD/death, a maximum of approximately 82 monthsPopulation: Patients who had a response event per Independent Review Committee.
The time (in months) from the date of first dose of tazemetostat until the earliest date of disease progression or death from any cause. Per RECIST v1.0, CR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Outcome measures
| Measure |
Phase 1
n=48 Participants
Patients in the Phase 1 portion of the study. Tazemetostat: Patients who received 100 mg to 1600 mg of tazemetostat, BID, administered in continuous 28-day cycles.
|
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2
n=54 Participants
Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy
n=163 Participants
Patients with R/R DLBCL received 800 mg of tazemetostat monotherapy, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy
n=71 Participants
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. In addition, these patients also received prednisolone 40 mg/m\^2 on Days 1 to 5 and 15 to 19 from Cycle 1 to Cycle 4 post which tazemetostat monotherapy was continued.
|
|---|---|---|---|---|
|
Progression Free Survival for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)
|
13.8 months
Interval 10.9 to 22.1
|
11.1 months
Interval 3.7 to 14.6
|
1.9 months
Interval 1.8 to 3.2
|
1.8 months
Interval 1.6 to 2.0
|
Adverse Events
Phase 1: Tazemetostat 100 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1: Tazemetostat 200 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1: Tazemetostat 400 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1: Tazemetostat 800 mg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 6 deaths
Phase 1: Tazemetostat 1600 mg
Serious events: 5 serious events
Other events: 11 other events
Deaths: 7 deaths
Phase 1: Food Effect (All Patients)
Serious events: 6 serious events
Other events: 12 other events
Deaths: 9 deaths
Phase 1: Tazemetostat 800 mg + Midazolam 2 mg
Serious events: 2 serious events
Other events: 13 other events
Deaths: 5 deaths
Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH2
Serious events: 14 serious events
Other events: 46 other events
Deaths: 22 deaths
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2
Serious events: 16 serious events
Other events: 53 other events
Deaths: 23 deaths
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy
Serious events: 84 serious events
Other events: 147 other events
Deaths: 129 deaths
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy
Serious events: 47 serious events
Other events: 56 other events
Deaths: 59 deaths
Serious adverse events
| Measure |
Phase 1: Tazemetostat 100 mg
n=6 participants at risk
Patients received tazemetostat 100 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 200 mg
n=3 participants at risk
Patients received tazemetostat 200 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 400 mg
n=3 participants at risk
Patients received tazemetostat 400 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 800 mg
n=14 participants at risk
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 1600 mg
n=12 participants at risk
Patients received tazemetostat 1600 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Food Effect (All Patients)
n=13 participants at risk
Patients received tazemetostat 200 mg as a single oral dose on Day -8 either after fasting for 8 hours before dosing or immediately after consuming a high-fat breakfast on Day -8. Following a 7-day washout period, patients crossed over to receive the second tazemetostat 200 mg single oral dose on Day -1 in the opposite condition (fed or fasted).
|
Phase 1: Tazemetostat 800 mg + Midazolam 2 mg
n=13 participants at risk
Patients received tazemetostat 800 mg orally BID continuously starting on Day 1, with a single oral dose of midazolam 2 mg administered on Day -1 and then on Day 15. Post Day 15, patients continued to receive tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH2
n=48 participants at risk
Patients with R/R FL with mutant EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2
n=54 participants at risk
Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy
n=163 participants at risk
Patients with R/R DLBCL received 800 mg of tazemetostat monotherapy, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy
n=71 participants at risk
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. In addition, these patients also received prednisolone 40 mg/m\^2 on Days 1 to 5 and 15 to 19 from Cycle 1 to Cycle 4 post which tazemetostat monotherapy was continued.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
16.7%
2/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.8%
2/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Empyema
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.1%
1/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.2%
2/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Septic shock
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
33.3%
1/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
3.7%
2/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.8%
3/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
4.2%
3/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
16.7%
2/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
4.9%
8/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
9.9%
7/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.8%
2/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.1%
1/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.4%
12/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
9.9%
7/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.1%
1/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.2%
2/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
16.7%
1/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
33.3%
1/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
33.3%
1/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.1%
1/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.1%
1/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
3.1%
5/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
33.3%
1/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.4%
2/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
3.7%
2/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
5.5%
9/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
11.3%
8/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
4.2%
3/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Surgical and medical procedures
Pain management
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.8%
2/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.2%
2/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.8%
3/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.8%
2/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.2%
2/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.8%
2/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.2%
2/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.2%
2/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.8%
2/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma transformation
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Osmotic demyelination syndrome
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.2%
2/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
8th nerve paralysis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.8%
2/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal disorder
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
Generalised oedema
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
Axillary pain
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
Breakthrough pain
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
Chills
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
Malaise
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.8%
2/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
Pain
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.1%
1/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.2%
2/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.2%
2/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Cardiac disorders
Pericarditis constrictive
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Investigations
Creatinine renal clearance abnormal
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.2%
2/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.9%
1/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.2%
2/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.61%
1/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Investigations
General physical condition abnormal
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.2%
2/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
Other adverse events
| Measure |
Phase 1: Tazemetostat 100 mg
n=6 participants at risk
Patients received tazemetostat 100 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 200 mg
n=3 participants at risk
Patients received tazemetostat 200 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 400 mg
n=3 participants at risk
Patients received tazemetostat 400 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 800 mg
n=14 participants at risk
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Tazemetostat 1600 mg
n=12 participants at risk
Patients received tazemetostat 1600 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 1: Food Effect (All Patients)
n=13 participants at risk
Patients received tazemetostat 200 mg as a single oral dose on Day -8 either after fasting for 8 hours before dosing or immediately after consuming a high-fat breakfast on Day -8. Following a 7-day washout period, patients crossed over to receive the second tazemetostat 200 mg single oral dose on Day -1 in the opposite condition (fed or fasted).
|
Phase 1: Tazemetostat 800 mg + Midazolam 2 mg
n=13 participants at risk
Patients received tazemetostat 800 mg orally BID continuously starting on Day 1, with a single oral dose of midazolam 2 mg administered on Day -1 and then on Day 15. Post Day 15, patients continued to receive tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH2
n=48 participants at risk
Patients with R/R FL with mutant EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH2
n=54 participants at risk
Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study. Patients received 800 mg of tazemetostat, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy
n=163 participants at risk
Patients with R/R DLBCL received 800 mg of tazemetostat monotherapy, orally BID, administered in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent.
|
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy
n=71 participants at risk
Patients received tazemetostat 800 mg tablets orally BID in continuous 28-day treatment cycles until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. In addition, these patients also received prednisolone 40 mg/m\^2 on Days 1 to 5 and 15 to 19 from Cycle 1 to Cycle 4 post which tazemetostat monotherapy was continued.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.3%
2/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.4%
2/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
46.2%
6/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
6.2%
3/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
18.5%
10/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.3%
25/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
18.3%
13/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
21.4%
3/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
22.9%
11/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
13.0%
7/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
3.7%
6/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.8%
2/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
21.4%
3/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
30.8%
4/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
4/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
9.3%
5/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
22.7%
37/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
18.3%
13/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.1%
1/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
16.7%
2/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
4/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.4%
4/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
9.8%
16/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
9.9%
7/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.3%
2/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
50.0%
6/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
23.1%
3/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.4%
2/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
20.8%
10/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
25.9%
14/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
22.1%
36/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
12.7%
9/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
33.3%
1/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
21.4%
3/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.4%
2/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
30.8%
4/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
10.4%
5/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
13.0%
7/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.1%
23/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
16.9%
12/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.3%
2/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
16.7%
2/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
23.1%
3/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
23.1%
3/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
10.4%
5/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
5.6%
3/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.6%
14/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
5.6%
4/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.3%
2/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
16.7%
2/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
22.9%
11/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
18.5%
10/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
17.2%
28/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.5%
11/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
21.4%
3/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.4%
2/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
16.7%
8/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
9.3%
5/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.4%
12/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
16.9%
12/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
10.4%
5/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
3.7%
2/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
4.9%
8/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.8%
2/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
Asthenia
|
66.7%
4/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
33.3%
1/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
33.3%
1/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
71.4%
10/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
33.3%
4/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
53.8%
7/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
53.8%
7/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.6%
7/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
22.2%
12/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
9.8%
16/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
21.1%
15/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
33.3%
1/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.4%
2/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
10.4%
5/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
5.6%
3/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.4%
12/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
11.3%
8/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.1%
1/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
25.0%
3/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
4.2%
2/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.8%
8/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.3%
25/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
9.9%
7/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
18.8%
9/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
16.7%
9/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.1%
23/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
9.9%
7/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.1%
1/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.4%
2/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
10.4%
5/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
3.7%
2/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.4%
12/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
4.2%
3/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
21.4%
3/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
12.5%
6/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
16.7%
9/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
6.1%
10/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.0%
5/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
27.1%
13/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
13.0%
7/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
4.9%
8/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
1.4%
1/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
4/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
9.3%
5/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
3.7%
6/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.8%
2/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
33.3%
1/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
33.3%
1/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
21.4%
3/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
16.7%
2/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
23.1%
3/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
23.1%
3/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
12.5%
6/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
3.7%
2/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.0%
13/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.1%
10/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
16.7%
1/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.3%
2/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.4%
2/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
2/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
42.9%
6/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
16.7%
2/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
23.1%
3/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
4/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
11.1%
6/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
4.3%
7/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.8%
2/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.1%
1/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.4%
2/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.6%
7/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
11.1%
6/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
9.8%
16/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
5.6%
4/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.1%
1/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
33.3%
4/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
12.5%
6/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
3.7%
2/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
4.3%
7/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.8%
2/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
12.5%
6/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.8%
8/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
4.3%
7/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.8%
2/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.1%
1/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
4/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
5.6%
3/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
3.1%
5/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
33.3%
1/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.1%
1/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
16.7%
2/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.4%
2/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.4%
2/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
6.2%
3/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
11.1%
6/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
4.3%
7/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
2.8%
2/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.3%
2/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
16.7%
2/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
7.7%
1/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.6%
7/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
20.4%
11/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
19.6%
32/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.5%
6/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.3%
2/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
16.7%
2/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/3 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
14.3%
2/14 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
8.3%
1/12 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.4%
2/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
15.4%
2/13 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/48 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/54 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/163 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
0.00%
0/71 • Treatment-emergent adverse events are reported from the first dose of study drug (Day 1) until confirmed disease progression, unacceptable toxicity, or withdrawal of consent. A maximum of approximately 40 months for Phase 1 and 82 months for Phase 2
The safety population included all patients in the Intent-to-treat (ITT) population set who had at least 1 post-dose safety observation recorded. MedDRA v17.1 for Phase 1 and MedDRA v18.1 for Phase 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60