Trial Outcomes & Findings for ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas (NCT NCT02264613)
NCT ID: NCT02264613
Last Updated: 2026-01-13
Results Overview
Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
142 participants
Primary outcome timeframe
From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
Results posted on
2026-01-13
Participant Flow
Participant milestones
| Measure |
Dose Regimen A (DR-A) PTCL Expansion
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen C (DR-C) PTCL Expansion
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (1.25 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (2.10 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regiment A (DR-A) Escalation (3.10 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (4.40 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.80 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.10 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.50 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.00 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.70 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Combination With Palbociclib Expansion
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
16
|
5
|
3
|
4
|
3
|
6
|
9
|
11
|
3
|
5
|
3
|
4
|
4
|
5
|
6
|
34
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
7
|
|
Overall Study
NOT COMPLETED
|
20
|
16
|
5
|
3
|
4
|
2
|
5
|
9
|
10
|
3
|
5
|
3
|
4
|
4
|
5
|
4
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas
Baseline characteristics by cohort
| Measure |
Dose Regimen B (DR-B) Escalation (2.00 mg/kg)
n=5 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.70 mg/kg)
n=6 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) PTCL Expansion
n=21 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen C (DR-C) PTCL Expansion
n=16 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
n=5 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
n=3 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
n=4 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (1.25 mg/kg)
n=3 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (2.10 mg/kg)
n=6 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (3.10 mg/kg)
n=9 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (4.40 mg/kg)
n=11 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
n=3 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
n=5 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.80 mg/kg)
n=3 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.10 mg/kg)
n=4 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.50 mg/kg)
n=4 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Combination With Palbociclib Expansion
n=34 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 17.78 • n=3 Participants
|
49.3 years
STANDARD_DEVIATION 14.97 • n=3 Participants
|
59.8 years
STANDARD_DEVIATION 16.62 • n=6 Participants
|
59.5 years
STANDARD_DEVIATION 14.21 • n=3 Participants
|
54.4 years
STANDARD_DEVIATION 15.04 • n=210 Participants
|
50.7 years
STANDARD_DEVIATION 22.37 • n=19 Participants
|
64.0 years
STANDARD_DEVIATION 5.29 • n=123 Participants
|
66.3 years
STANDARD_DEVIATION 9.02 • n=123 Participants
|
53.8 years
STANDARD_DEVIATION 13.75 • n=615 Participants
|
59.3 years
STANDARD_DEVIATION 13.17 • n=20 Participants
|
61.5 years
STANDARD_DEVIATION 11.01 • n=13 Participants
|
58.9 years
STANDARD_DEVIATION 12.75 • n=335 Participants
|
58.4 years
STANDARD_DEVIATION 12.76 • n=451 Participants
|
54.7 years
STANDARD_DEVIATION 4.04 • n=6 Participants
|
65.2 years
STANDARD_DEVIATION 8.64 • n=77 Participants
|
55.3 years
STANDARD_DEVIATION 1.53 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 11.77 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 13.40 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
8 Participants
n=3 Participants
|
2 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
2 Participants
n=123 Participants
|
1 Participants
n=123 Participants
|
4 Participants
n=615 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=13 Participants
|
3 Participants
n=335 Participants
|
2 Participants
n=451 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=77 Participants
|
2 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=3 Participants
|
4 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
8 Participants
n=3 Participants
|
3 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=123 Participants
|
2 Participants
n=123 Participants
|
2 Participants
n=615 Participants
|
5 Participants
n=20 Participants
|
5 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
3 Participants
n=451 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=77 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=123 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=3 Participants
|
5 Participants
n=3 Participants
|
18 Participants
n=6 Participants
|
12 Participants
n=3 Participants
|
4 Participants
n=210 Participants
|
3 Participants
n=19 Participants
|
2 Participants
n=123 Participants
|
2 Participants
n=123 Participants
|
5 Participants
n=615 Participants
|
7 Participants
n=20 Participants
|
11 Participants
n=13 Participants
|
2 Participants
n=335 Participants
|
3 Participants
n=451 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=77 Participants
|
4 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=335 Participants
|
2 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=3 Participants
|
1 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
2 Participants
n=615 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=13 Participants
|
1 Participants
n=335 Participants
|
1 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=77 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=3 Participants
|
5 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
8 Participants
n=3 Participants
|
4 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=123 Participants
|
2 Participants
n=123 Participants
|
4 Participants
n=615 Participants
|
7 Participants
n=20 Participants
|
8 Participants
n=13 Participants
|
2 Participants
n=335 Participants
|
4 Participants
n=451 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=77 Participants
|
3 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=123 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=615 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=3 Participants
|
6 participants
n=3 Participants
|
21 participants
n=6 Participants
|
16 participants
n=3 Participants
|
5 participants
n=210 Participants
|
3 participants
n=19 Participants
|
4 participants
n=123 Participants
|
3 participants
n=123 Participants
|
6 participants
n=615 Participants
|
9 participants
n=20 Participants
|
11 participants
n=13 Participants
|
3 participants
n=335 Participants
|
5 participants
n=451 Participants
|
3 participants
n=6 Participants
|
4 participants
n=77 Participants
|
4 participants
n=7 Participants
|
34 participants
n=5 Participants
|
142 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 DaysNumber of participants with treatment-related adverse events as assessed by CTCAE v.4.0
Outcome measures
| Measure |
Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation
n=9 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation
n=11 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
n=3 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
n=5 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.80 mg/kg)
n=3 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.10 mg/kg)
n=4 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.00 mg/kg)
n=5 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.50 mg/kg)
n=4 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.70 mg/kg)
n=6 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) PTCL Expansion
n=21 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen C (DR-C) PTCL Expansion
n=16 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
n=5 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
n=3 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
n=4 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation
n=3 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation
n=6 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Combination With Palbociclib Expansion (DR-A)
n=34 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists
|
9 Participants
|
11 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
21 Participants
|
16 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
34 Participants
|
PRIMARY outcome
Timeframe: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 DaysNumber of participants with treatment-related adverse events as assessed by CTCAE v.4.0
Outcome measures
| Measure |
Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.80 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.10 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.00 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.50 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.70 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) PTCL Expansion
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen C (DR-C) PTCL Expansion
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
n=21 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
n=16 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
n=34 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Combination With Palbociclib Expansion (DR-A)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists, Expansion
|
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21 Participants
|
16 Participants
|
34 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 DaysDetermine the maximum tolerated dose (MTD)
Outcome measures
| Measure |
Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.80 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.10 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.00 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.50 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.70 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) PTCL Expansion
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen C (DR-C) PTCL Expansion
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
n=41 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
n=30 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Combination With Palbociclib Expansion (DR-A)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Determine the Maximum Tolerated Dose (MTD) of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas
|
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—
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—
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—
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—
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—
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—
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3.1 mg/kg
|
NA mg/kg
No MTD found
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 DaysThe proportion of efficacy-evaluable patients who achieve complete response (CR) or partial response (PR), per investigator assessment, in accordance with RECIST 1.1 or iRECIST (for solid tumor patients) or Response Assessment in Neuro-Oncology (RANO) criteria (for glioblastoma patients).
Outcome measures
| Measure |
Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.80 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.10 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.00 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.50 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.70 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) PTCL Expansion
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen C (DR-C) PTCL Expansion
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
n=21 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
n=16 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Combination With Palbociclib Expansion (DR-A)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Determine Overall Response Rate
|
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—
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—
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—
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—
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—
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—
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—
|
—
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—
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2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 DaysPopulation: The efficacy evaluable population was defined as those patients who met all of the following criteria: (1) Received at least 1 dose of ALRN-6924 at a dose level at least 0.8 mg/kg per infusion (2) Had at least 1 postbaseline evaluation or had clinical disease progression (3) Were TP53 wild type or indeterminate (as assessed by the central laboratory; if not assessed by central laboratory, as assessed by the local laboratory.
The proportion of efficacy-evaluable patients who achieve complete response (CR) or partial response (PR), per investigator assessment, in accordance with RECIST 1.1 or iRECIST (for solid tumor patients) or Response Assessment in Neuro-Oncology (RANO) criteria (for glioblastoma patients).
Outcome measures
| Measure |
Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation
n=7 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation
n=8 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.80 mg/kg)
n=3 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.10 mg/kg)
n=4 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.00 mg/kg)
n=4 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.50 mg/kg)
n=4 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.70 mg/kg)
n=6 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) PTCL Expansion
n=16 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen C (DR-C) PTCL Expansion
n=11 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation
n=2 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation
n=3 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Combination With Palbociclib Expansion (DR-A)
n=25 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Assess Additional Measures of Anti-tumor Activity, Including Duration of Response, Progression Free Survival, Overall Survival and Time to Response
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The Pharmacokinetic Analysis Population included all subjects who received at least one dose of ALRN-6924 with sufficient plasma sample data to assess PK parameters, and with no major protocol violations. Plasma samples for subjects in the Combination With Palbociclib Expansion arm were collected but will not be processed or analyzed due to a protocol-level decision for this expansion arm to discontinue pharmacokinetic data collection.
Time of Peak Plasma Concentration (Tmax)
Outcome measures
| Measure |
Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation
n=9 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation
n=11 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
n=3 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
n=5 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.80 mg/kg)
n=3 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.10 mg/kg)
n=4 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.00 mg/kg)
n=5 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.50 mg/kg)
n=4 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.70 mg/kg)
n=6 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) PTCL Expansion
n=21 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen C (DR-C) PTCL Expansion
n=16 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
n=5 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
n=3 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
n=4 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation
n=3 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation
n=6 Participants
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Combination With Palbociclib Expansion (DR-A)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Determine Pharmacokinetic Parameters of ALRN-6924 When Administered to Patients With Advanced Solid Tumors or Lymphomas
|
0.12 hour
Interval 0.0 to 0.65
|
0.06 hour
Interval 0.03 to 1.0
|
0.17 hour
Interval 0.15 to 0.18
|
0.22 hour
Interval 0.02 to 1.0
|
0.08 hour
Interval 0.07 to 0.08
|
0.29 hour
Interval 0.02 to 0.5
|
0.30 hour
Interval 0.05 to 0.5
|
0.08 hour
Interval 0.02 to 1.0
|
0.03 hour
Interval 0.0 to 1.02
|
0.05 hour
Interval 0.02 to 0.48
|
0.05 hour
Interval 0.0 to 0.52
|
0.03 hour
Interval 0.0 to 0.52
|
0.13 hour
Interval 0.07 to 0.5
|
0.04 hour
Interval 0.02 to 0.47
|
0.04 hour
Interval 0.02 to 0.07
|
0.29 hour
Interval 0.0 to 1.0
|
—
|
Adverse Events
Dose Regimen B (DR-B) Escalation (1.5 mg/kg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose Regimen B (DR-B) Escalation (2.0 mg/kg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose Regimen B (DR-B) Escalation (2.7 mg/kg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Regimen A (DR-A) PTCL Expansion
Serious events: 7 serious events
Other events: 19 other events
Deaths: 0 deaths
Dose Regimen C (DR-C) PTCL Expansion
Serious events: 7 serious events
Other events: 15 other events
Deaths: 0 deaths
Combination With Palbociclib Expansion
Serious events: 5 serious events
Other events: 34 other events
Deaths: 5 deaths
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose Regimen A (DR-A) Escalation (1.25 mg/kg)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Regimen A (DR-A) Escalation (2.1 mg/kg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose Regimen A (DR-A) Escalation (3.1 mg/kg)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Dose Regimen A (DR-A) Escalation (4.4 mg/kg)
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose Regimen B (DR-B) Escalation (0.8 mg/kg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Regimen B (DR-B) Escalation (1.1 mg/kg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Regimen B (DR-B) Escalation (1.5 mg/kg)
n=4 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.0 mg/kg)
n=5 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.7 mg/kg)
n=6 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) PTCL Expansion
n=21 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen C (DR-C) PTCL Expansion
n=16 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Combination With Palbociclib Expansion
n=34 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
n=5 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
n=3 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
n=4 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (1.25 mg/kg)
n=3 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (2.1 mg/kg)
n=6 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (3.1 mg/kg)
n=9 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (4.4 mg/kg)
n=11 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
n=3 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
n=5 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.8 mg/kg)
n=3 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.1 mg/kg)
n=4 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
hypotension
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
22.2%
2/9 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
2.9%
1/34 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
6.2%
1/16 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
2.9%
1/34 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
2.9%
1/34 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
6.2%
1/16 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
2.9%
1/34 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
2.9%
1/34 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Endocrine disorders
AKI
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Blood and lymphatic system disorders
hypercalcemia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Blood and lymphatic system disorders
Subarachnoid Hemorrhage
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
6.2%
1/16 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Blood and lymphatic system disorders
Subdural Hemorrhage
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
6.2%
1/16 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
6.2%
1/16 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Blood and lymphatic system disorders
Hyponatraemia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
18.8%
3/16 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Gastrointestinal disorders
CDIFF
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
4.8%
1/21 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
6.2%
1/16 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Blood and lymphatic system disorders
Histiocytosis Hamatophagic
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
4.8%
1/21 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
6.2%
1/16 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Blood and lymphatic system disorders
Hypokalemia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
12.5%
2/16 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
6.2%
1/16 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Cardiac disorders
Atrial Fibrulation
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
6.2%
1/16 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Infections and infestations
Escherichia bacteremia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.1%
1/11 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.1%
1/11 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Nervous system disorders
CVA
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.1%
1/11 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Infections and infestations
Pseudomonal bacteremia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.1%
1/11 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Blood and lymphatic system disorders
Tongue Hemorrhage
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.1%
1/11 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
4.8%
1/21 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
4.8%
1/21 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
14.3%
3/21 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
4.8%
1/21 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Gastrointestinal disorders
Pelvic Pain
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
4.8%
1/21 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
4.8%
1/21 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Infections and infestations
Pyrexia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
4.8%
1/21 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
4.8%
1/21 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
Other adverse events
| Measure |
Dose Regimen B (DR-B) Escalation (1.5 mg/kg)
n=4 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.0 mg/kg)
n=5 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (2.7 mg/kg)
n=6 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) PTCL Expansion
n=21 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen C (DR-C) PTCL Expansion
n=16 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Combination With Palbociclib Expansion
n=34 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
n=5 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
n=3 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
n=4 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (1.25 mg/kg)
n=3 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (2.1 mg/kg)
n=6 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (3.1 mg/kg)
n=9 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen A (DR-A) Escalation (4.4 mg/kg)
n=11 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
n=3 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
n=5 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (0.8 mg/kg)
n=3 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
Dose Regimen B (DR-B) Escalation (1.1 mg/kg)
n=4 participants at risk
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
ALRN-6924: ALRN-6924 will be administered as an IV infusion
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomitting
|
50.0%
2/4 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
40.0%
2/5 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
2/6 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
14.3%
3/21 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
12.5%
2/16 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
38.2%
13/34 • Number of events 13 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
66.7%
2/3 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
66.7%
4/6 • Number of events 4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
77.8%
7/9 • Number of events 7 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
36.4%
4/11 • Number of events 4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
40.0%
2/5 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
100.0%
3/3 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
50.0%
2/4 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Gastrointestinal disorders
Nausea
|
100.0%
4/4 • Number of events 4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
100.0%
5/5 • Number of events 5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
50.0%
3/6 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
47.6%
10/21 • Number of events 10 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
43.8%
7/16 • Number of events 7 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
55.9%
19/34 • Number of events 19 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
50.0%
2/4 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
100.0%
3/3 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
83.3%
5/6 • Number of events 5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
100.0%
9/9 • Number of events 9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
54.5%
6/11 • Number of events 6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
100.0%
3/3 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
80.0%
4/5 • Number of events 4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
100.0%
3/3 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
75.0%
3/4 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
60.0%
3/5 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
2/6 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
14.3%
3/21 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
12.5%
2/16 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.6%
7/34 • Number of events 7 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
16.7%
1/6 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
22.2%
2/9 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
18.2%
2/11 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
100.0%
3/3 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
75.0%
3/4 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
2/6 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
14.3%
3/21 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
12.5%
2/16 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
40.0%
2/5 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
66.7%
2/3 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
50.0%
3/6 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
22.2%
2/9 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
4.8%
1/21 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
6.2%
1/16 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
16.7%
1/6 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
22.2%
2/9 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
66.7%
2/3 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
General disorders
Fatigue
|
75.0%
3/4 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
80.0%
4/5 • Number of events 4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
2/6 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
42.9%
9/21 • Number of events 9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
37.5%
6/16 • Number of events 6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
35.3%
12/34 • Number of events 12 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
60.0%
3/5 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
50.0%
2/4 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
100.0%
3/3 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
83.3%
5/6 • Number of events 5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
44.4%
4/9 • Number of events 4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
81.8%
9/11 • Number of events 9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
66.7%
2/3 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
40.0%
2/5 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
75.0%
3/4 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
General disorders
Asthenia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.5%
2/21 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
6.2%
1/16 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
11.1%
1/9 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
18.2%
2/11 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
16.7%
1/6 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
4.8%
1/21 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
12.5%
2/16 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
11.1%
1/9 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.1%
1/11 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
50.0%
2/4 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
16.7%
1/6 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
4.8%
1/21 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
12.5%
2/16 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
11.8%
4/34 • Number of events 4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
66.7%
2/3 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
50.0%
2/4 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
66.7%
2/3 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
50.0%
3/6 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
3/9 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.1%
1/11 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
66.7%
2/3 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
16.7%
1/6 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
4.8%
1/21 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
6.2%
1/16 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
2.9%
1/34 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
11.1%
1/9 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
40.0%
2/5 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
60.0%
3/5 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
2/6 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
19.0%
4/21 • Number of events 4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
4/16 • Number of events 4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
66.7%
2/3 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
2/6 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
22.2%
2/9 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
18.2%
2/11 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
40.0%
2/5 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
50.0%
2/4 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
2/6 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
22.2%
2/9 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
18.2%
2/11 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
66.7%
2/3 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
16.7%
1/6 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
11.8%
4/34 • Number of events 4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
16.7%
1/6 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
40.0%
2/5 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
66.7%
4/6 • Number of events 4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.5%
2/21 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
6.2%
1/16 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.6%
7/34 • Number of events 7 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
50.0%
3/6 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
55.6%
5/9 • Number of events 5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.1%
1/11 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
66.7%
2/3 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
40.0%
2/5 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
50.0%
2/4 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
2/6 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
14.3%
3/21 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
6.2%
1/16 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
35.3%
12/34 • Number of events 12 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
11.1%
1/9 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.1%
1/11 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
16.7%
1/6 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
4.8%
1/21 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
12.5%
2/16 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
70.6%
24/34 • Number of events 24 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
18.2%
2/11 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
35.3%
12/34 • Number of events 12 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
16.7%
1/6 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.1%
1/11 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
22.2%
2/9 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
18.2%
2/11 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.5%
2/21 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
11.8%
4/34 • Number of events 4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
2/6 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
22.2%
2/9 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.1%
1/11 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
14.3%
3/21 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
18.8%
3/16 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
18.2%
2/11 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
2/4 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
4.8%
1/21 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
6.2%
1/16 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
2/6 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
3/9 • Number of events 3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
18.2%
2/11 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
11.8%
4/34 • Number of events 4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
2/6 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
14.7%
5/34 • Number of events 5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
11.1%
1/9 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.1%
1/11 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
40.0%
2/5 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
16.7%
1/6 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/21 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
14.7%
5/34 • Number of events 5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
33.3%
1/3 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
General disorders
Malaise
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
20.0%
1/5 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
16.7%
1/6 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.5%
2/21 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/11 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
9.5%
2/21 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/16 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/34 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
25.0%
1/4 • Number of events 1 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/6 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/9 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
18.2%
2/11 • Number of events 2 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/5 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/3 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
0.00%
0/4 • From Day 1 of treatment until the last post treatment visit 30 days after the last treatment dose, an average of 138 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place